To the eleventh, twenty twenty-four. My name is Joshua Korsen, and I'm an H.C. Wainwright Equity Research Associate. So today, I would like to introduce our presenter, Eric d'Esparbes, who is the CFO of Biora Therapeutics, which specializes in the development of innovative smart pill technologies to improve patient lives. The floor is yours.
Thank you very much, and want to thank H.C. Wainwright for inviting us to the conference, today. Good afternoon, everyone. I'll be happily presenting Biora Therapeutics and our programs. We're going to make some forward-looking statements today in this presentation, so we invite investors to read the risk factors in our SEC filings. Biora, we are a therapeutics company. We have two programs we're focused on. Both are drug device combination products. First one is NaviCap, where we aim to change the way we approach a treatment of GI diseases by delivering drugs precisely at the site of the disease in the GI tract and reducing exposure to the systemic circulation with those drugs. I'll talk about this program shortly.
The other program is BioJet, where we're trying to make biologics and large molecules available in oral form. It's a very large market. Patients have to have injections. A lot of patients don't like needles, so we've put together an approach and a way to deliver these drugs orally. So NaviCap first. We're focused initially in the IBD space on ulcerative colitis. There's about one million people in the U.S. annually who suffer from Ulcerative Colitis or UC. It's a disease of the colon.
There are different levels of disease, but it's largely a disease of the distal colon, so the descending colon and the rectum, which means that it's very difficult for the drugs to actually reach the area where the inflammation is located. It's a very active sector for drug companies. Here we show all the currently approved drugs that are in the market to treat UC. However, there is a clear therapeutic ceiling that exists, that is about 20%-30% above placebo, where drugs beyond that level have not been able to demonstrate efficacy, which means that you have, like, 60+% of the patients who really don't have a solution for them.
That's a really big problem because the disease can be extremely challenging for patients, leading ultimately to surgery and removal of sections of the GI tract, which is really not a great outcome. Why is there a therapeutic ceiling? We believe that the challenges have been... These molecules are very powerful and effective, but there's also a lot of toxicity associated with these molecule. Ultimately, what it means is that once those drugs are administered through IV or subcu, you have to expose the whole systemic circulation to those molecules, and only a fraction of it reaches the colon where the disease is located. Yet the whole system, the whole body, is exposed to toxicity. Effectively, it's almost like you have a dose-limited treatment.
The solutions, you know, to those problems can potentially be by delivering the drug locally at the site of the disease and bypassing the systemic circulation, or greatly potentially reducing exposure to the drug in the systemic circulation. The other challenge in treating UC is that there seems to be more than one mechanism of action that create this disease. Combination therapy, if you talk to KOLs and doctors, more and more are talking about that strategy where you hopefully would use more than one drug to treat it. But because of toxicity, it's extremely difficult to achieve.
So what Biora has done is developed a smart pill, a smart device, that actually directly delivers at the site of the disease, at the entrance of the colon, a liquid formulation that coats the colon. The UC is effectively a topical disease of the lining of the colon, rather than delivering the drug in the systemic circulation. We are in the clinic. We recently announced the results of our phase I clinical trial in healthy volunteers, and we were extremely happy with the results. Frankly, we could not ask for a better outcome of this study.
We had run a lot of functional studies with the device in healthy volunteers and UC patients, with without food, et cetera, but it was the first time we ran a study where we delivered the actual drug in combination with NaviCap. We had a KOL event a couple of months ago, where we're very happy to have Dr. Bruce Sands and Dr. Brian Feagan to come and speak about the unmet need and the implications of the results of our clinical trial, but also the potential for the platform. So what did we achieve? We achieved a PK profile that we wanted that is consistent with drug delivery in the colon. What that means is, drug in the blood was detected only after six hours or more.
That shows that the device took the time that was needed to reach the entrance of the colon, deliver the drug, and then, the drug reaches a systemic circulation. But because of that delivery approach, we're able to demonstrate two, three to four times lower drug in the blood than with the actual commercial drug, which is XELJANZ, the Pfizer drug. The other thing that we were able to demonstrate is pancolonic drug delivery. As you saw earlier, this disease is a disease of the entirety of the colon, but more precisely, the descending colon and rectum. So it's these are really hard areas to reach. We're able, through biopsies, to demonstrate pancolonic coverage. Device function was excellent. It was well tolerated.
So basically, we demonstrated this platform can potentially be used for UC with BT-600, but also potentially more broadly with other drugs. We've demonstrated that this technology, this platform can work. The results, and we have a KOL deck on our website. We invite you to consult it if you're interested in the clinical results. But here, we try to show the difference between BT-600 versus the commercial XELJANZ in terms of Tmax, in terms of, you know, Cmax and AUC. And what we see is that by delivering even a lower dose than the commercially available drug, we're able to achieve a lower exposure in the blood, and at the same time, as I'll present in the following pages, higher potential tissue concentration.
Why I say potential is that as part of the study, we had to take biopsies. After the last daily dose of the MAD phase of the study, we had to do a fair amount of bowel prep and took biopsies at three different sites in the colon. Even there, even after 24 hours after the last dosing, which represents approximately five half-lives for tofa, we were able to detect pancolonic coverage throughout the colon. If you look at the next page here, the concentration that we were able to achieve, even after 24 hours, bowel prep, et cetera, we're able to achieve more than IC50 tissue concentration.
But the other aspect that was very interesting was we saw a very clear correlation between blood and tissue concentration over time, which means we can project what the effective tissue exposure would likely be up to 16 hours after a dose. And we can clearly see here that it's the effective tissue concentration would be much higher than IC90 through at least 16 hours. And earlier last year, one KOL that is on our clinical advisory board ran a clinical study to try to identify why certain patients respond to XELJANZ while other don't. And they were able to clearly identify that responders to XELJANZ achieve tissue concentration above IC90. So that's why we're so excited with the result of this study. One, less blood exposure to the drug.
Second, well tolerated by the subjects. And third, very high potential for drug exposure to at the site of disease, which means that drug exposure tends to correlate with endoscopic healing. So we're very excited to move this program into the next phase of its clinical development, where we hope to run BT-600 in UC patients. So currently, we're in the process of establishing the right next step for next clinical study for this program, because our goal is to try to generate as much patient efficacy data as early as possible in a responsible way in terms of capital allocation. So we'll follow up in the not too distant future with our plan on the next clinical stage.
The other thing that I want to say is that we believe that this clinical trial proves that the platform itself, it works, it's safe, it performs as intended and can deliver any payload. So which means that it could work with not just with JAK inhibitors, but also TNF inhibitors, integrin inhibitors, et cetera. So we think that this platform, NaviCap, can truly be a platform play, where we can deliver multiple molecules for the treatment of IBD disease, and in this case, especially UC. The next program is BioJet. So BioJet, instead of delivering drug in a specific location in the GI tract, here, we're trying to replace needles.
A lot of patients who use biologics, and in this case here, we show the case of diabetes, there's a high proportion of patients who don't do all their injections, which leads to compliance issues, just because they don't like needles. Surprisingly, there's a lot of patients who actually, even though they need their drug, they're not compliant with their regimen just because of injections. So our goal with BioJet is to replace needles and deliver drugs through to the systemic circulation. Here is a simpler device compared to the NaviCap, where through, with an enteric-coated trigger, once the device enters the small intestine, it triggers liquid jets that basically deliver the drug through jets, through the mucosa-...
and into the capillary bed of the stomach for systemic absorption and circulation. We can deliver large payloads with this. We're talking about milligrams, not micrograms, and that means that it, it's amenable to a wide range of potential drugs. For this program, we've been focusing on trying to demonstrate its compatibility with a lot of different drugs, different type of molecules. So we've used semaglutide, we've had really great results. We've used adalimumab, and with pharma collaborators, early-stage collaborators, we've been able to generate data for them on top of the molecules that we've been running ourselves, which leads to a big body of data that has demonstrated that we can achieve very high bioavailability and a relatively consistent delivery.
These are two important principles for pharma to potentially consider this solution for their molecules, because these are very expensive drugs. You need to make sure that there's enough that goes into the systemic circulation, and it needs to be consistent so that the administration on a daily or bi-daily or every other day is effective to achieve the concentration level that is required in the blood. So we've generated, over the last few quarters, a fair amount of data for our pharma collaborators, and we're at the stage now where we've stated previously that our goal for this program is to partner it with pharma. And we announced a few months ago that we had an active partnering process.
And we're at the stage here where we are actively engaged with several of our pharma collaborators into potentially partnering this program. Our strategy, our goal, is to be able to generate multiple verticals for with different pharma companies, you know, to make sure that this becomes widely available, and also leverage pharma dollars to get through the clinic, so in this case, the goal is to really make sure we maximize non-dilutive source of capital, which could help extend runway for the company and provide well, validation, if you want, from big pharma. We're at the stage now where we're, and we've made statement recently about the status of our negotiations with our pharma collaborators, so we view BioJet as having category-leading bioavailability and performance.
We've heard a lot, a conversation in the markets around different potential solutions, but frankly, the data that we've shared in different conferences, in scientific conferences and scientific papers, clearly illustrate that we think we are creating the leading performance for oral delivery with BioJet. It has broad applicability. We've shown consistent performance with different types of molecules, and we are in advanced stage of working with pharma to partner the asset. So we're very excited. We're very close to having very interesting event and catalyst in front of us, and we think it should be very interesting in terms of potential outcome. So with NaviCap, we had great results.
We're at the stage we're moving into the next clinical stage for this program. And with BioJet, we're actively working on partnering the program. With that, I'll be happy to take any questions.
Thank you, Eric, for your presentation, and I'd like to open up the floor if anyone here would like to ask any questions, well, thank you again, Eric, for presenting at our conference this year, and for those on the webcast, please feel free to reach out to management for any questions or follow-up. Thank you.
Thank you.