First new class of antibiotics in over 40 years. We find ourselves in a privileged position with an advanced phase III trial underway at this moment for diabetic foot ulcer infections. We have multiple phase I and phase II candidates in unmet medical need patient populations, and we have a U.S. Department of Defense program running in parallel. We have over 40 granted patents, and our products are on track to be commercially available later this year. As a snapshot of our company to introduce ourselves, I actually started as the founding investor supporting my grandfather, a former Head of Johnson & Johnson Research Australasia, so a third of the globe in his retirement.
Together with Michele Dilizia, we really made our first discovery to really identify a compound that works and keeps on working with repeated use, one of the greatest challenges of antibiotics or antibiotic resistance today. Various members, of course, also joined me on the board, and particularly you'll hear from today Dr. John Prendergast, our Chairman, Michele Dilizia, our fellow board member and Chief Scientific Officer, and Dr. Alan Dunton, our Chief Medical Advisor and fellow board member. What makes Recce so different is we work broader than any other antibiotic known to date, and we work and keep on working with repeated use, which means we're valuable and useful today and will continue to be in the future.
We work in minutes and not hours or even days like some traditional antibiotics, and we have multiple forms available or formulations available to target the bacterial species no matter where it is. I'm pleased to present our guest speakers today over this presentation, and we'll be joining you at the end of this presentation for a Q&A.
I'm Dr. Alan Dunton. I'm the Chief Medical Advisor, and I'm also a Director of Recce Pharmaceuticals Ltd. Today I'd like to share with you some clinical highlights from our development program with our lead product, which is RECCE 327, and actually the lead product is the gel formulation. We also have an IV formulation, which has been studied. It's pointed to the excellent safety profile of RECCE 327. We've given up to 4 g of the product without any significant adverse events. We've never seen a serious adverse event with the intravenous product. That's provided a really good background and understanding of the pharmacokinetics of the product for the other programs. We also have a spray which will be used for respiratory infections and inhalation product.
We have some excellent preclinical data in mouse models of various very nasty bug infections like Acinetobacter baumannii, but that development is a little bit behind because we decided to focus on the gel product for diabetic foot infections. Why is that? If we could have the next slide, please. Infections of diabetic foot ulcers. Next slide, please. It's a very complex environment. You can imagine that thinking about your feet and your lower extremities. In diabetics, they have problems with their kidneys, they have problems with their vasculature. If any of you have members of your family that are diabetic and somewhat have had it for many years, you'll know that there's a lot of things that go wrong. They're also very susceptible to infections.
They don't have good sensations in their feet, and they tend to bang their feet walking, even with shoes on, and those slight bumps can become infected. It's very difficult to treat infections in these patients, and why is that? Well, they don't have good blood flow to their feet and their legs. So if you give an antibacterial or an antibiotic by an oral route or an intravenous route, guess what? It may not even get there. They also tend to have a very high bacterial count, and there's very delayed healing. As I mentioned, they have problems with their immune system, so healing takes a long time.
There's no standard of care of how to treat patients around the world, not just in any individual country, and most physicians who use these patients or take care of these patients, you know, use cocktails of medications, and it's almost like an art rather than a science at all. When even you manage these local infections, as I mentioned, there's no standard of care. The ideal would be where you could get an antibiotic directly on the wound, and that's why we are using a gel and why we're so excited about it, 'cause our product has a novel mechanism of action. It's very fast-acting. If you look in our test tubes and our in vitro studies against all bacteria, first of all, we've never had a bacteria tested that didn't succumb to the effects of RECCE 327, and it happens very quickly.
It's measured in minutes rather than in hours into days, what most antibacterial products take to have an effect. As I said, it has a broad spectrum of activity. It's a perfect compound to use in this type of situation where you don't even know what bug you're treating or bacteria you're treating at the time. So you don't have to go around, take biopsies, and see which bug is there. It's first-line therapy that can be used right away. So we designed this RECCE 327 gel with this complex situation in mind, because number one, it's easy to apply. You can imagine you open the tube, and it can be applied directly. You don't even need blood flow there because the drug is already there.
As I mentioned earlier, it has a very broad spectrum, and it could even work against an infection where you have many different types of bacteria that are present in the wound. It's a perfect setup for the use of this kind of product. To my knowledge, there's no gel product approved, topical antibiotic product approved for use in diabetic foot infections. If we can go to the next slide, let's talk a bit more about our product. There's the tube of RECCE 327 gel. As I mentioned, you don't even have to identify the pathogen or the bacteria that's being treated. You can use it as an outpatient very easily. You don't have to expose the patient to a very high level systemically of an antibiotic.
If you've ever been on antibiotics, they can cause havoc, especially oral products. They can give you upset stomachs, can produce diarrhea 'cause it wipes out all the bacteria in the gut. Not a pleasant thing to have to take an antibiotic for seven to 14 days. It's necessary sometimes, but we don't think you have to do it here. You can start with a topical gel early on in the course of infection, so it can be treated and not, you know, get worse and have some dire consequences. We've done testing and I'll come to that later, the actual data, but you can see a response within 24-72 hours of the first dose of the drug. You can see a decrease in that redness and the swelling, and you can also see a decrease or actual.
You can stop the pus that's formed by these infections, which is basically white cells that the body is sending there to attack the infection. It's a very rapid onset of effect. When some physicians use oral or intravenous antibiotics, they can be on these things for weeks. We hope that's not the case in our, all of our testing, and we have some very good data, which I'll share later in the presentation. It's very safe. We've looked at how much drug is absorbed from intact skin where the drug is applied or even in these wounds. If you have intact skin, there's absolutely no drug that gets into the systemic circulation.
In a diabetic foot ulcer or other types of infections where there's an open wound, you can see very, very small concentrations, which it's amounts to about 50 mg given systemically, which is a very, very small dose of this drug. It's very, very low. Even if it was absorbed, the drug is so safe, as we showed in the intravenous program that we have, there's no ill effects that it causes upon the body. You know, I've used it on a few infections I've had in my hands and my feet, and it's a clear gel. It's very soothing and actually feels pretty good. You can use it once daily, with a small bandage on top that's put in place. Next slide, please. Let's move on to this program.
It's an interesting history, actually. So the first study we actually did was a spray, liquid spray formulation of RECCE 327. We studied patients who had diabetic foot infections. It was a hospital in... it's called Liverpool Hospital in South Western Sydney Local Health District. We studied a handful of patients out there, and lo and behold, all of them responded to the drug. In fact, in some of them, over a very short period of time, we were seeing these diabetic wounds actually starting to close and to heal completely, which is an incredible feat, pardon the pun, but you know, most of these wounds take a very long time to heal. Now, one thing, you need to heal the infection before this open ulcer has any chance of closing.
Without this treatment, the patient wouldn't have had a chance to heal their wound and close it and prevent any further reinfection of the wound. That we looked at that data and said, "Well, let's go after a gel formulation, which would be much easier to use." We also did a phase I study in patients who had infected burn wounds, and we showed that it was safe. I believe none of the patients had any serious adverse events. One patient had a little bit of tingling. Patients with burns have very sensitive skin. Their nerves have all been shattered, if you will. There were no serious adverse events in this study. It was done at a hospital in Western Australia near Perth, which specializes in burn treatment. We were very pleased with that.
By this point, we had a gel which we were going to put in clinical trials, but we also used another way to understand the drug a little bit better. The Therapeutic Goods Administration in Australia has something called a special access scheme, where any physician can request an investigational product to treat their patients under their care as long as they abide by the TGA's requirements, which is basically to ask permission and if the company says yes. Well, we said yes to a number of these special access scheme requests, and we saw incredible results.
I think one of the physicians who's an orthopedist in North Sydney used it on a number of patients, and one patient who had an infected ulcer on his ankle, he saw a response within 24 hours. He was amazed, and that patient went on to completely heal that ulcer in very short order. He had a number of other very difficult patients that he couldn't cure with oral antibiotics, and he used the gel, and it resulted in a cure. He's been very pleased with the product and is looking forward to further developments as well.
We did proceed to start a phase II trial and complete a phase II trial, at least the first part of that trial, in patients that had something called acute bacterial skin and skin structure infections, affectionately known as ABSSSI. I'll come to a little more extended data on that, but the high percentage of those patients, I think it was greater than 90%, achieved a positive primary and secondary endpoint. It was healing of the ulcer from the infection, and the patients did very well. It was safe. We looked at absorption of the drug, as I mentioned earlier, and it was minimal absorption. This study also included patients with diabetic foot infections. They're in the broad category of ABSSSI, and they also responded nicely as well.
We decided to focus on diabetic foot infections going forward, and I'll talk about a little bit more about that in a couple of minutes. Can I have the next slide, please? This is the more complete results of that phase II study in patients with infections on their skin and skin structure infections. It enrolled 30 patients. There were 29 included in the final analysis. There was a patient that was withdrawn. She had some pain which existed before she entered the site, and the pain became problematic for her, so she dropped out within the first or second day of the study. Other patients went on to complete the study. As I mentioned, these 29 patients.
After seven days of treatment, seven days of once-daily treatment, 86 of the patients had a positive clinical response and a successful clinical response. We continued treatment for 14 days, and that number increased to 93% of patients. That's a really astounding number in a phase II trial. This is an open label study, meaning there was no comparator in the trial. There was no placebo or active other antibiotic that used in another set of patients, but still was dramatically positive to the point that we felt we could move into a phase III study. It was very safe. There was no adverse events or serious adverse events. I should just point out that the assessment method is something called the Lipsky scale.
For the infection, you look at 7 parameters such as redness and swelling and exudate and, you know, pus exudate, et cetera. They're scored from zero to three, three being the worst, if you will. It's really bad. For 7 parameters, you can have a score as high as 21. A positive in this study was significant improvement or an absolute cure over that course of therapy. You know, it takes time for the body to respond. You can kill the bacteria in minutes, but the body still has to catch up with the response and slow down the immune system, if you will, to get rid of the redness, swelling, and in many cases, irritation as well. We were so pleased with that study, we proceeded to then another study on the next slide.
If I could have the next slide, please, which is a phase III trial. We were actually working with the government of Australia and speaking to folks in Indonesia because they have a huge problem with diabetes in Indonesia. They have so many patients that have infected feet. I mean, I'm sorry, infected diabetic foot ulcer infections because that environment is very difficult, right? It's very humid. They wear primarily sandals or flip-flops, not complete shoes. Their diabetes, unfortunately, is not treated aggressively. We began at the end of last year, 2025, a phase III trial, which was approved by their local regulatory body in Indonesia called the Badan POM, B-P-O-M, BPOM. That study has been running now. It's where are we today? Is it mid of March.
We're open at five sites across Indonesia from the west to the east. As you can see, the population of Indonesia is very diverse, subpopulations, et cetera. The BPOM wanted us to study across the geography of Indonesia. The primary endpoint here is the clinical response to diabetic foot infection according, again, to the Lipsky scale. The second secondary endpoint is the total wound score, which is a measure of how wide and how deep the ulcer is primarily, and also obviously the safety of 327 gel. Really excited. We'll be performing an interim analysis this year, when we complete 155 patients. We're gonna enroll approximately 300 patients total, and then we'll look forward to registering the drug first in Indonesia.
The good news too is Indonesia is one of the ASEAN countries, and if you get a drug approved in one of the ASEAN countries, it opens up the door to all the other ASEAN countries as well to seek approval. We're very excited about this evolution. As I mentioned when I started the talk today, we're working in other areas. We have an IV formulation. We also have an aerosol formulation for lung infections. It's becoming very popular now to try to treat patients with an inhaled version of an antibiotic for the same reason we're giving a topical gel. You're getting the drug to the site of action where it is most needed, and you're not exposing the rest of the body to that drug.
I think that's the last slide if we can move this one forward. I think it is, and I really want to thank you for your attention. Keep your eye out for more good news from Recce Pharmaceuticals. Have a good day. Thank you so much.
Good day, everybody. My name is Nathan. I'm the CEO of Etana, and today I would like to introduce about Etana and Recce cooperation in Indonesia. Next. First, I would like to introduce about Etana. Etana is one of the few biopharmaceutical company in Indonesia. Indonesia, there's only three vaccine company, and we're one of them, and there's only two company focusing in biotherapeutic, and we're one of the two. As a company, we're really focusing in the whole biopharmaceutical field. One of the key purpose for us is really to provide a better standard care for the people in Indonesia. That's why we're very excited that today we have a very strong collaboration with Recce Pharmaceuticals to bring their new product, their new technologies to the Indonesian patient in Indonesia. Next.
With partnership with Recce, we also go through a very strong collaboration by doing a late-stage clinical trial in Indonesia. This will allow the Indonesian patient to get first-hand the treatment. It also gonna help tremendously the clinician how to treat the patient better with Recce technology. We also get a full support from both governments, both from Indonesian government, both from Australian government, to perform the clinical trial. It actually has been quite a very long time that there has been a very strong collaboration between two pharmaceutical companies in Indonesia and Australia. This has also marked a very significant milestone within the cooperation between the two countries.
We really hope that the clinical trial of Recce will run very successful, because it will not just also mark the collaboration successful, but also mark in term of the impact that we can do for the Indonesian patient. Obviously, what Recce offer bring us, you know, a tremendous opportunity, to have a better standard care in the Indonesian healthcare, which is actually really need a lot of upgrade. With Recce, we're doing phase three clinical trial in Indonesia. We're gonna involve hundreds of clinical trial patient, and then we hope we can complete it within this year. We can also hope that with the trial completed this year, we will also gonna get approval this year.
The topical product, although it looks simple, will represent a very major step for our cooperation in treating diabetic foot for patients, in Indonesia, where we don't really have a lot of options. By Recce providing that technology, it will provide a better option to support our patients' needs. We really thank you for the collaboration between us and Recce, and we're really sure that this product could really contribute to the better safety and better health for the Indonesian patients. Thank you so much.
Hi, everyone. My name is Dr. Jane. I'm currently stationed as the Clinical Research Department Head in Siloam Hospitals, Siloam Clinical Research . A bit of background for Siloam Hospitals. We are currently the largest private hospital network in Indonesia, and we are aiming to become the trusted destination for holistic and world-class healthcare. Having 41 hospitals, 76 clinics across 38 cities in Indonesia, we are in the position to advance technologies in healthcare, and we are always inspired to provide the healthcare that we can have for our Indonesian patients. We've been this, in these industries for more than 30 years now, and we are in the position to have so many firsts in Indonesia. We are the first hospital in Indonesia to have the first JCI-accredited hospital.
We have our top prime private center hospital as well in MRCCC in Jakarta and so on and so forth. One thing that we realized during, especially during the COVID pandemic is that if we want to keep advancing in technologies in healthcare, we need to also invest in clinical research because it is the future of medicine. Cannot just deliver services without contributing to the research welfare as well. That is why five years ago we decided to build this department in the hopes of being the one-stop center for all the clinical research activities in Siloam Hospitals because we do believe that clinical research is the foundation of advancing healthcare.
It will ensure that the medical intervention are not only safe and effective but also relevant to the people that we serve. In Indonesia alone, much of our medical practice has historically relied on research from other countries. While these global studies have offered great insights, such findings may not always address the specific health needs for our local populations. In Siloam, we have managed to bridge this gap and it is a clear mission for us to contribute meaningfully to global research while we strengthen the quality and relevance of clinical trials for Indonesian patients. Our portfolio has risen to 32 projects in the last four years. The top therapeutic areas would be oncology, infectious disease, and neurology. We've been receiving many tropical diseases trials.
I would say that it is contributing to the factor that we are in a tropical country and that leads us to one of our exciting projects with Recce Pharmaceuticals. We've been introduced to this project around two years ago and we know that through these clinical trials, the work with Recce Pharmaceuticals, we are able to provide some access to our Indonesian patient who has a diabetic foot ulcer condition. It's one of the way to find a new treatment regimens to the current DFU populations. We are looking forward to continuously support Recce Pharmaceuticals and this clinical trial.
We have been working with two Siloam Hospitals, one in Siloam Hospitals Lippo Village in Karawaci, and then the other one is in Bali, Siloam Hospitals Denpasar. We've supported them with the patient recruitment, doing the informed consent, monitoring the visit, we do the follow-ups and so far, all the patient has been treated with this, either Recce or the placebo that we provided. All in all, we're very excited. We will look into the preliminary result later on, and I'm looking forward to finish this study. Thank you so much.
I'm David Lasseter, the Founder and Partner at Horizons Global Solutions, and we've been working with Recce now for a couple of years to develop the strategy and to execute the strategy and working with the United States Federal government and specifically right now with the Department of Defense or Department of War.
My previous experiences most recently with the United States government were is serving as the Deputy Assistant Secretary of Defense for Countering Weapons of Mass Destruction. In that role, I oversaw all programs, policies, and strategies related to CBRN defense both internationally and working with U.S. government interagency partners. One of the major issues that I would oversee was the biological threat response and spectrum. What RECCE 327 is doing is exactly what the Department of Defense, Department of War are seeking. Ryan?
Thanks, David. Ryan Kane, Managing Director of RK Strategies. RK Strategies is a healthcare, life sciences and preparedness lobbying consulting firm, helping biodefense companies, public health companies navigate the U.S. government. Simultaneously, I also serve as the Vice President of a leading biodefense company, and previously worked for several United States senators, members of Congress, mostly in political but also policy capacities, and eventually turned to the private sector. David and I have been working together very closely to help develop Recce's U.S. government programs, and we're excited to share more with you today about that. Next slide, please.
Next slide. As we've been working together, you know, most of it is focused on ensuring that what Recce is doing is answering the call of the United States government and in this case for the Department of Defense and the war fighter. Now when we talk about, you know, providing the best capabilities, you know, we also talk about doing this at the point of care, doing this on the battlefield to provide a capability to as quickly as possible to the war fighter that being either, again, on the battlefield or at the closest level of care.
This is both for antimicrobials, but also, and probably most importantly in a lot of the research that Recce is undertaking now with the United States government, that is in burn and blast wounds as well as combat wounds. This is a very important area that the department wants to continue to try to get a hold on. Ryan, other thoughts?
Thanks, David. Other areas the government's looking very closely at, of course, is antimicrobials, which continues to pose a significant challenge. We've seen that out in the field, for instance, in Ukraine, Israel and other areas in the theater where there is significant infection on the battlefield and current antimicrobial candidates are not able to support those wounds. All that to say, the U.S. government has looked very closely at R327 and has supported it through several programs in large part because of its broad utility as a new antimicrobial candidate that also addresses the burn and blast areas, combat wound infections, and of course, biodefense threats. I would also point out that the U.S. government has moved towards the adoption of pathogen-agnostic approaches.
Think of drugs that can treat multiple bugs versus the old model, which was one drug to treat one bug, and that model's failed in the U.S. government. They've moved to look at rapid treatment options that can treat a wide array of threats, including threats that are unknown, that are easy to scale and shelf stable, and this sort of thing. R327 really fits the bill nicely. Next slide, please.
As we discussed a little bit previously, you know, the challenges for the United States military are quite significant in this area. We want to be able to save the limbs, to stave off infection, to provide a countermeasure as quickly as possible, because it will The department would then have a better chance of again providing the best solution to those wounds and then, you know, preventing the potential loss of limb and even more than that, life. Most of these are, you know, multiple potent bacteria.
Something like R 327 has the ability, as we've seen, to kill all of it, and that's absolutely essential because it enables that, you know, that application to be applied to any wound in any climate and place, which is something the Department of War obviously seeks routinely, you know, as a global environment for potential operations. Included this would be, you know, obviously relief for pain a war fighter might experience and to promote essential wound healing.
I know, Ryan, we talk about antimicrobial resistance being, you know, only growing and growing as the years go out, and such a capability as R 327 will provide the right solution for the United States government, and in this case, we've discussed the U.S. war fighter and our allies. Over to you.
Thanks, David. The other area I would add is that there's broad application as well within the biological threats. These are Category A and B agents that are incredibly deadly, and that are significant concerns. Adversaries to the United States and to our allies are actively developing some of these agents today, and the U.S. government is looking to develop medical countermeasures that may treat it. R327 really fits the bill nicely.
As we'll talk about in a future slide, the compound's been tested and is in testing against a number of these Category A and B agents. Meanwhile, it's also highly efficacious against more of the common infections. Across a variety of formats, a gel, a hydrogel. A number of other formats as well, such as IV, where there's a lot of different routes of administration to treat a lot of different infections and that really drives the utility of this compound. Next slide.
We're really excited. We've been working on three areas in particular with the U.S. Department of War. The first is the congressionally directed medical research programs. It's an annual program that the United States Congress funds specific areas for the Department of Defense, Department of War, to research and provide capabilities, medical countermeasures and other research, to the department. It's a really important program. This particular opportunity that Recce was selected for is providing a synthetic anti-infective, as we've talked about, R 327, for treatment of burn wounds and the downstream impact.
This has allowed for the work and development of this room temperature stable, R 327 hydrogel or pardon me, hydrogel dressing in sachets, for field use. This will allow the treatment on burn wound infections and the current work is on animal models, and it's showing some success. It's been great to see thus far and know the department is eager to continue this work with Recce. Ryan.
That award, the CDMRP, is a highly competitive award. In fact, it's one of your most competitive grants that a company can receive. It's especially notable that Recce, an Australian company, was able to win this award. To win this award involves a very significant amount of vetting at the highest levels of thought leadership in the infectious disease space. Recce was able to come out on top and secure that. That was a several million-dollar contract that supported this program and continues to this day. Additionally, there are two other programs that are underway, both CRADAs, which is Cooperative Research Agreements, Research and Development Agreements.
The first one with the U.S. Army, USAMRIID, which is the U.S. Army Medical Research Institute of Infectious Diseases, and that's looking at a number of the Category A and B indications that I mentioned on the prior slide, Burkholderia, Yersinia pestis, Pseudomonas, this sort of thing. Some of the worst pathogens that are causing the most problems or of the most concern to the U.S. government. This testing is well underway today in a U.S. government laboratory. That program is funded today through the Defense Threat Reduction Agency support into that USAMRIID lab. The other program is at the U.S. Army Institute of Surgical Research, looking at reducing the bioburden of Pseudomonas in burn wounds. That's yet another extension of the ongoing U.S. government efforts.
All this to say with the two CRADAs and then of course the grant, it just underscores the promise of R327 in the eyes of the U.S. government. They're really excited about it because it's fitting the need of the U.S. government and continue to invest in it, and we would expect to see more in the future given the wonderful capability that this compound brings. Over to you, David.
Yeah. I think you nailed it there, Ryan, at the end that these three opportunities are, in our experience and our knowledge, are likely to lead to other, bigger and even better opportunities, with the United States government, which we're excited about. There are even a couple of opportunities this year that we're already surveying, and we believe, there's a high likelihood of success that RECCE 327 could be very competitive to winning some of these even larger awards. We're looking forward to that work. We know this is this is a many-year effort, and it's going to pan out to be quite incredibly capable for the United States war fighter and as we talked about our partners and allies as well. Thank you.
Thank you all.
Hello and welcome. My name is Michele Dilizia, and I am Recce's Chief Scientific Officer and an Executive Director. I work as a medical scientist and medical microbiologist, and my background with Recce began at its inception some 13 years ago when I joined with its founder and inventor, Dr. Graham Melrose, ex Johnson & Johnson, and a pioneering polymer chemist. Together, we worked to develop our lead candidate antibiotic compound, RECCE 327, and establish a recognized and globally patented brand new class of antibiotic technology to tackle the increasing threat of antibiotic resistance to worldwide healthcare.
In this presentation, we will take a look at some of the contributors to antibiotic resistance and some of the areas of very high unmet medical need where antibiotic resistance is increasing and infections are getting more and more difficult to treat or even not able to be treated with our current and traditional classes of antibiotics. I will present some compelling preclinical data that demonstrates the consistent and powerful efficacy of R327 to treat serious infections, particularly those characterized by antibiotic resistance, such as pneumonias in hospitals and in the ICU and tuberculosis. Finally, we will consider how this solid preclinical data establishes the foundation for new and successful treatments in the clinic and in the face of dangerous drug-resistant bacterial infections.
There are multiple drivers of antibiotic resistance, all of which have contributed to serious infections and which continue to threaten and weaken the ability to treat common infections. These infections then go on to become serious and life-threatening. For example, I'm looking at the various points on this slide. There is an overall and widespread overuse and inappropriate use of antibiotics in both animal care and human health care. This mass exposure has given bacteria unprecedented opportunity to adapt and mutate against these antibiotics, developing resistance to the point where we now have antibiotic resistance in every class of our current and traditional antibiotics. Taking a look now at VAP, which is ventilator-associated pneumonia. Multidrug-resistant pathogens are a primary feature of this serious pneumonia.
VAP is considered a subset of HAP, which is hospital-acquired pneumonia, and that typically occurs after about 48 hours of mechanical ventilation. This is when microaspirations of pathogenic bacteria in the throat are inhaled, they travel down the endotracheal tube and straight into the lung tissue, which is highly vascularized and so vulnerable to infection. This significantly increases the risk of patient death, and mortality rates are very high in these patients, ranging from 30%-70%. Common pathogens in this scenario are the notorious and increasingly drug-resistant Gram-negative bacteria such as Pseudomonas and Acinetobacter. Looking also further at VAP, we've mentioned that the prevalence of multi-drug resistant pathogens is a big driver. And so too is the increasing weakness of our present arsenal of antibiotics.
For example, most patients, at 60%, do not respond to first-line therapy. This entire situation only increases their time on mechanical ventilation and all its risks and leaves just further time for the critically ill patient to deteriorate. However, we will see in the following slides that RECCE 327 as a brand-new class of antibiotic effectively treats multi-drug resistant pathogens such as we've seen in VAP and HAP. For example, looking at this, pivotal proof of concept data, we have in a validated mouse model of HAP caused by Carbapenem-resistant Acinetobacter baumannii, let's call it CRAB.
Now this organism has been identified and tagged by the World Health Organization's priority pathogens list, and it has been allocated the most serious category of critical significance in view of its resistance to last resort antibiotics, severity of the infection it causes, and the significance of its global health burden. In this model here, Recce was successfully nebulized for delivery straight into the infected lung tissue, enabling direct treatment at the various lung sites of infection. After only 24 hours treatment, the bacterial burden in the lungs was reduced by a remarkable four logs, which 99.99% of bacteria and very close to the limit of detection in this assay. We also administered RECCE 327 intranasally and both intranasal and nebulizer resulted in significant bacterial reduction in the lungs, and it was also well tolerated.
It's noted that the comparator antibiotic was meropenem, which is not able to be nebulized, hence it does not have that great lung delivery that's possible with RECCE, and it's also not well tolerated with known side effects in the gastrointestinal tract. A second and highly significant global infection is tuberculosis, and this one is also in the WHO priority pathogen critical group. TB is considered one of the world's top infectious disease killers, taking out around 1.5 million people every year and around 10.8 million new cases every year worldwide. It's a particular burden in Indonesia, where Recce is currently conducting a major clinical trial to treat diabetic foot infection. Indonesia accounts for about 10% of global TB cases and making it one of the largest TB healthcare markets in the world.
We'll see in the following slide how RECCE 327 is uniquely and strongly placed to address this market of very great unmet need. We have here on this slide good and solid preclinical data in a validated model of TB infection in mice using the related organism Mycobacterium fortuitum. It's a recognized proof of concept model, and after seven days of intravenous treatment with RECCE 327, the mice exhibited significant decreases in bacterial load in their kidneys compared to the vehicle controls. It was a bactericidal three-log reduction, well-tolerated, correlated with reduced kidney lesions. It was a result that was superior to the comparator antibiotic rifampicin. We've seen, of course, very good preclinical data. The question then, of course, is, okay, how is this going to translate in the clinic?
Pleasingly, we have moved from, you know, standard and reference validated in vivo models. We also backed that up with testing clinical isolates of bacteria from the Centers for Disease Control, from their infectious disease bank. We tested RECCE along with common everyday antibiotics against nearly 700 clinical multidrug resistant isolates. In all cases, they were susceptible to RECCE. However, in the comparator antibiotics, a significant proportion were resistant. Coming to our conclusion now, another significant and very pleasing feature of RECCE is that it acts very quickly, within minutes and not within hours. We're looking at a much less exposure time to affect potential systemic toxicity. In this assay, we tested against several common everyday antibiotics, all of which have tried to tackle bacteria in various ways through mechanisms of action.
For example, bacterial cell wall synthesis, that cefalexin, DNA replication, ciprofloxacin, cell membrane, colistin, and protein synthesis, the tetracycline. Recce outperformed all of these classes of antibiotics, and it did so quickly. It's been my pleasure to present this bank of outstanding preclinical data to you. I believe it resoundingly demonstrates the unique and powerful properties of the RECCE 327 antibiotic technology and its ability to tackle the rising global threat of antibiotic resistance. Thank you.
Hello, I'm John Prendergast. I'm the Executive Chairman of Recce Pharmaceuticals, and I'm delighted to be with you today to present a company overview and to give you a flavor of what we anticipate over the next 12 to 24 months. Before I do that, I want to draw your attention to the fact that there are almost 5 million deaths globally from antibiotic-resistant infections. Roughly 75% of antibiotics in development are derived from existing drugs, and it's inevitable that bacteria will develop resistance to these newly derived antibiotics. What does that mean? The antibacterial pipeline is in crisis, and as the WHO has pointed out recently, last year, this is due to a scarcity of products and a lack of innovation. So much so that in the past 10 years, only two have represented new chemical classes.
Effectively, this represents that the development of innovation in antibiotic space is essentially stagnant. When it comes to our company, we are looking at being truly innovative, just like other disease areas that have had high-impact innovative products over the last 20 years. For example, in the arena of cancer, PD-1 antibodies have transformed the treatment of certain cancers. In the area of obesity, which has been such a growing global problem, GLP-1 inhibitors have impacted that dramatically. When it comes to infectious diseases, there are no truly new innovative products.
Recce's polymer platform represents the opportunity to really innovate because it's a fully synthetic polymer platform that's designed to disrupt the essential component of any growing cell, particularly bacteria, and that's the production of energy. The World Health Organization recognized it last year as the only molecule that stands out as a fully synthetic compound that targets ATP production, which is the essential energy production arena within a bacteria or any growing cell. Confidence we've gained from knowing that we have a truly innovative product has allowed us to develop a proprietary program pipeline depicted in this slide. We have wanted to access the market as quickly as possible with this particular product, and consequently, we've developed a program in diabetic foot ulcer infections that originally was conducted in Australia.
Because of the enormous opportunity in diabetic foot ulcer infections in the ASEAN region, particularly in Indonesia, where there is a population of 280 million people with 10% of the population having diabetes, this has allowed us to develop a registrational strategy where we are conducting a phase III trial in Indonesia, and with that registration in the course of the next 12 months, that would allow us to expand into the ASEAN region. Behind that, we will continue, we can conduct our topical gel program in Australia that would then allow us to move over to other additional registration clinical trials that would support a registration package for the U.S.
Underpinning this all is a safety program where we administered RECCE 327 IV in over 150 human volunteers, where we saw no aberrant safety parameter or physical effect of the drug in any way, shape, or form. In addition to our lead program, we're looking to expand our pipeline through the inhalation of RECCE 327, particularly applied to lung infections. These particular lung infections are hospital-acquired pneumonia and ventilator-associated pneumonia. We have already conducted studies to demonstrate the efficacy of RECCE 327 when it's delivered to the lung. These two programs would also allow us to not only access those type of infections, but potentially be applicable to other diseases such as tuberculosis and potentially cystic fibrosis. This truly represents an exciting program.
We have recently been awarded a $2 million grant by the U.S. Department of War that would further our opportunities in the topical gel space, particularly as is applied to the war combat veteran, where in the field, any particular type of wound could be treated with a topical gel, as well as burn wound infections that we are conducting under a cooperative research and development agreement with two other agencies in the U.S. Department of Defense. As we roll out our commercial strategy, as I mentioned, we are conducting the phase III trial in Indonesia, and that allows us to access the other ASEAN countries by virtue of the harmonization guidelines between regulatory jurisdictions. Moreover, that opportunity would also lend itself to expanding our reach into the Middle East North Africa region. Why so?
Because between the two regions, MENA and ASEAN, there are over 120 million diabetic patients, of which there would be a representation of approximately 10 million diabetic foot ulcer infections. This is a significant market. In conjunction with that, we'll continue our regulatory and manufacturing base in Australia, and those critical studies will then allow us to expand into the world's largest infectious disease therapeutics market, which is obviously the U.S.A. We're very confident of being able to adopt an impactful global commercial strategy. When we look at Recce today, I want to present several key takeaways that really underpin the future value of the company as a true innovator in the infectious disease space.
It's important to recognize that this particular polymeric platform is broad spectrum because part of the significant problems associated with traditional antibiotic development has been the lack of antibiotics to target more than one bacterium at any one time. We target bacteria independent of resistance to other antibiotics. More importantly, we've tested the polymer in over 750 clinical isolates and never failed to kill the bacteria within minutes. That's part of the effective mechanism of action. It's not in hours or days like traditional antibiotics, but it demonstrates amazing lethality in minutes. In passaging experiments, which are truly the standard bearer for determining whether an antibiotic has the ability to kill multiple times, we've tested in passaging series of up to over 100 times and never seen development of resistance.
As I mentioned before, in our clinical studies, one of the key things going forward with these programs is to show that the product is safe and our safety profile is outstanding. When we consider what we are trying to achieve with the topical gel, we want it to be targeting the site and acting rapidly at that site, unlike oral or IV antibiotics, which can take hours to days to be effective. As we progress our studies of topical gel and success with our phase III program, we believe that this will become the standard of care for diabetic foot infections globally, and so would afford us the opportunity to price the product in a premium manner. In fact, all our pipeline opportunities are driven towards premium price therapeutic areas and will be used on a global commercial basis.
Currently, we've had several reports that have valued the company significantly above where our current market cap is. While this is really reassuring and represents opportunity, what I truly want to reflect is that the innovation and the other pipeline opportunities that are available within the company over the coming years have not been necessarily reflected in these valuations. We believe that the company has true upside above and beyond these current projected valuations. Why so? Because Recce is a pioneer in the development of a new era of anti-infectives. It has the world's first synthetic anti-infective platform that we believe will be able to engineer on an ongoing basis to outsmart superbugs and the superbug crisis. It is the first novel class of antibiotics in over 40 years, and we are rapidly de-risking this through our registrational phase III trials in Indonesia and potentially in Australia.
This will become the first topical anti-infective approved for the treatment of DFIs, and more importantly, from a global perspective, will be the first standard of care. We have multiple value-creating opportunities across a series of other pipeline programs that meet unmet global needs, as I mentioned, particularly in the area of lung infections for hospital-acquired pneumonia and ventilator-associated pneumonia. All these programs are designed to impact multi-billion dollar markets that are in dire need of innovative treatments. What I'd like to leave you with is that Recce is a pioneer, certainly, but we want to become a global leader in the anti-infective space, and we truly represent the first broad spectrum effective antibiotic/anti-infective in over 40 years. I wanna thank you for your attention, and I look forward to updating you over the course of the next 12 months on our programs. Thank you.
Thank you, John, and thank you for those joining us today. I'd like to say a particular thank you for our speakers and of course the many efforts that our team make to make this opportunity possible. That concludes the formalities of today's presentation, which will be made available on the company's YouTube, across our websites, and of course our social media. I have noticed a couple of questions that have popped through in the background, so we'll take a brief moment to touch upon those and of course welcome questions anytime along the way. The first question I see here from Warren is saying, "Assuming the phase III clinical results in Indonesia are positive, when do you think Recce would have a marketable product?" Well, I think Recce is purely focused upon getting a marketable product as quickly as possible.
As we heard today, from the CEO of Etana, Nathan, in fact, Etana being one of the largest, if not the largest Indonesian pharmaceutical company, we are focused upon a commercial approval and commercial sales that come with that approval this calendar year. We validate ourselves with the ability to do that based upon the sum of clinical data to date, the expedited regulatory review status we have with the Indonesian regulator, BPOM or Badan POM, and of course, the unique positioning that our product provides. The next question I have here is, fair enough, "Why can't the FDA accept the phase III trial result from Indonesia?" The simple answer is the FDA, like any regulator, has the ability to ask for more.
When we submit to the FDA in the timelines obviously mentioned, we will be submitting the Indonesian data and all data from all regions of the world. The FDA has the ability as the regulator to ask for a little more data, and we believe it's responsible and appropriate to assume they will ask for more data. We don't expect to do a large phase III in Indonesia or anything similar, but we would expect reasonably that there could be a local study. You know, some 20, 50 patients perhaps for the regulator to be specific of diabetic foot ulcer infection patients in their region, being the United States. Next question.
Can re-elaborate on the specific clinical and operational milestones should investors watch over the next six to 12 months?" Well, clearly our focus at this moment is this late stage registrational phase III study. It's an incredibly exciting stage because it's the stage just before market. One of the key pieces to watch is in fact the commerciality, and what I really mean by that is the partnering opportunities, the licensing opportunities or hybrids thereof. Where we have one compound or one indication being for diabetic foot ulcer infections in Indonesia currently, that regulatory pack is acceptable across the ASEAN group of countries, MENA group of countries, and potentially other regulatory authorities as well, which means we have commercial discussions in those markets, and those commercial discussions are happening right now.
Naturally surrounding that, clinical data are coming out, commerciality supporting the market launch of that, and then of course some U.S. Department of Defense engagements in the background. I'd also positively allude to our patent portfolio expanding. In fact, you know, anyone can log into the patent office and see how things are going. I saw only this week two additional patent offices, the United States and Brazil, have accepted our most recent patent claims, which means naturally, assuming no opposition, they progress to grant in the very near term.
That's a good step and extends our market monopolies. That concludes the formality of today's presentation. Like I expressed, please do email your questions or we'll do our best to come back to specific questions if I've missed any there in the background. Thank you very much for the opportunity of today.