Good afternoon and welcome to the Relmada Therapeutics virtual KOL event. At this time, all attendees are in a listen-only mode. A question-and-answer session will follow the formal presentations. If you'd like to submit a question, you may do so by using the Q&A text box at the bottom of the webcast player. As a reminder, this call is being recorded, and a replay will be made available on the Relmada website following the conclusion of the event. Before we begin, the company would like you to refer to slide 2 for a cautionary statement regarding today's discussion. I'd now like to turn the call over to Sergio Traversa, Chief Executive Officer at Relmada Therapeutics. Please go ahead, Sergio.
Thank you, Tara, and good afternoon, everyone, and welcome to the Relmada NDV-01 KOL call. On today's call, Dr. Boris Certin will review the top-line phase 2 data of NDV-01, as presented earlier today at the American Urological Association. Professor Certin is the Chairman of the Department of Urology and Pediatric Urology at the Shaare Zedek Medical Center. Professor Certin is the principal investigator of the phase 2 trial of NDV-01 in high-risk non-muscle invasive bladder cancer and presented the data today at the AUA. Following the NDV-01 data presentation, we'll have a discussion and question-and-answer session with Dr. Lotan and Dr. Certin. Now, turn the call to Dr. Certin to review the first top-line phase 2 results for NDV-01 presented today. You can move to the next slide.
Before you do that, I just would like to give you a quick overview of what NDV-01 is, and if you can move to the next slide. NDV-01 is an intravesical therapy that is designed for an extended release of gemcitabine and docetaxel through chemotherapy they used in the treatment of cancer. NDV-01 is an in-situ reservoir that stays inside the bladder and delivers simultaneously a fixed-dose combination of gemcitabine 1,000 milligrams and docetaxel at 40 milligrams. NDV-01 releases the drug into the bladder continuously over 10 days of time. It is biodegradable, and it gradually disintegrates and is safely excreted in the urine. NDV-01 has been demonstrated in the interim phase 2 data to be safe, highly tolerable, and resulting in good patient compliance. It is supplied in a prefilled syringe that is easily installed in the office, in the doctor's office, in less than 10 minutes.
You can go to the next slide. It is a graphical representation of how NDV-01 forms a matrix inside the bladder, and the chemotherapy is released over 10 days through different mechanisms of action. At this point, with no further delays, I would like Dr. Certin to go through the data. Boris, you have the stage.
Sergio, thank you very much. May I have a next slide, please? Thank you very much for the very kind presentation. As Sergio told, my name is Boris Certin. I'm the Chairman of the Urology Department at Shaare Zedek Medical Center in Jerusalem, and I was a PA, and hopefully still will be a PA in this study. It's an ongoing study, open-label, single-arm, single-centered. We aim to evaluate the efficacy and durability of NDV-01 in high-risk non-muscle invasive bladder cancer patients. Just in general speaking, this is a very difficult group of patients. The bladder cancer, high-risk patients, very nasty disease, very hard to treat, and the consequences of untreated patients are very, very devastating.
In order to avoid the further development of disease and avoid the disease will become to be muscle-invasive and metastatic disease, we have to do everything in order to avoid it and to try to delay when we are going with our patient for radical cystectomy or different treatments. The inclusion criteria for this study was high-grade disease, the patient with Ta carcinoma in situ patients, patients with T1 with carcinoma in situ, or Tis patients. We decided to include patients with BCG naive patients, so patients that never got any BCG intravesical treatment, BCG unresponsive patients, or patients who were not able to proceed with BCG intravesical therapy because of the side effects of BCG. As Sergio told before, our main purpose was to evaluate with this pivotal study the potential of NDV-01 as a safe and effective treatment for these patients.
The primary endpoint is safety and complete response at 12 months during the therapy. The second point was disease efficacy. We wanted to see if overall survival was patients, and of course, we would like to measure the concentration of gemcitabine and docetaxel, which are inside of this formulation during the study period, to see if it would not cause any systemic events. The study design is very simple. We wanted to enroll 70 patients with high-risk, non-muscle invasive bladder cancer. The study protocol is biweekly, once in two weeks, instillation of the NDV. If the patients are free of disease, we are going for the maintenance therapy every six weeks, instillation as a maintenance. The follow-up is very clear. It is like in every patient with bladder cancer. We are taking urine cytology. We do the cystoscopy examination every three months.
We do proceed with the hypertrophic imaging, and we do TURBT or bladder biopsy if it's necessary, and also confirmatory biopsy in the patient with carcinoma in situ, just to be sure, as per indication of the FDA, there's no recurrence when we don't see any macroscopic lesions. We would like to be sure that there's no recurrence of carcinoma in situ in a normal bladder. Next slide, please. Okay, this is the patient demographic data. Actually, I think it reflects the general population of bladder cancer patients, the majority of male. The smoking status is equally divided by smokers and non-smokers, and the performance status of the majority of patients who were enrolled in this study was good. Next slide, please.
Okay, the pathology was divided, as shown in this slide, the 11% of patients with carcinoma in situ, TA high grade, 61% of the patients, and the remaining 27 patients with T1 high grade. Our status of our patients also, as we expected, we have half of the patients with BCG unresponsive disease, 11% of the patients who did not tolerate the BCG and required to switch them to alternative therapies, and nine patients, overall 34% of the patients with BCG naive, who never got any intravesical therapy. Next slide, please. It is very important to emphasize the negligible ratio of the side effects of our patients. If you look at the data, our data, the eight cases of very mild dysuria, which resolved during two days following the therapy, five cases of unspecific flank pain, which we attributed probably to the musculoskeletal origin.
It's very important that we ask our patients who had a history of the BCG therapy to compare the quality of life following BCG therapy and NDV-01, and the quality of life improved dramatically in all of patients who had a history of BCG therapy by 0.5008 points. The quality of life dramatically increased in patients who are able to compare the previous treatment with the current one. Next slide, please. This is the graph which shows you the durability and the response of the patients who are currently on the study. We currently enrolled 26 patients. Out of those, 20 patients completed three months of the follow-up. We have 85% high-grade recurrence-free survival. It's a very nice result.
It's very important that three patients who actually did show on the first cystoscopy examination recurrency, all three patients, they received another course of the induction therapy, another six-weekly installation. Out of those, one patient already concluded this course and underwent cystoscopy examination only last week and showed complete response. There's no recurrence whatsoever in any part of the bladder. The recurrence rate even went up after this patient. Next slide, please. At this slide, you can see the clinical activity at three months' point. As I told you before, on the left part of this slide, you can see the pathology of those patients. As I mentioned before, 85% showed no recurrence at three months of period. On the right side of the slide, you can see the response in naive, BCG naive, and BCG experienced patients. Next slide, please.
Next slide, please.
Next slide.
That's new. That's new.
What?
That's new.
Okay. Okay, sorry. That's another slide. It showed you the clinical activity of our patients at any time. You can see if you look at the overall survival, it's 90% of our patients actually showed a high-grade recurrence-free survival at this current stage of the study. That's at the right side of the slide. You can see the pathology, the status of those patients if you divide them according to BCG naive and BCG experienced patients. It's very important to show, although it's a very small group of patients, the complete response in carcinoma in situ patients, which are a very difficult group of patients, are over 100%. None of the carcinoma in situ patients, actually, all of them, they showed the complete response, which we proved by confirmatory biopsy. Next slide, please.
I think, Sergio, here, I can just forward the slides up to you.
Sure. This is a summary of the benefit that NDV-01 can bring to doctors and to patients. It's very easy to administer. It can be administered in the doctor's office without any anesthesia in less than 10 minutes, and that makes the workload much easier for the doctor and for the patients. It's a much less burden to take this form of delivering gemcitabine. With that said, I would like to open for the questions, and Tara, you can coordinate the question and answer.
Great. Thank you, Sergio. Yes, at this time, we'll be conducting a question-and-answer session with our speakers. As a reminder to the audience, if you'd like to submit a question, you may do so by using the Q&A text box at the bottom of the webcast player. To our analysts that are joining us live, please use the raise hand feature to indicate you have a question. Please hold for a brief moment. Our first question comes from Oi Ir at Mizuho. Please go ahead.
Thanks. Yeah, congrats on the data, guys. It seems like an exciting technology. Maybe our first question we've been sort of getting from investors was sort of, I think people were kind of surprised by the small number of patients with cysts versus the larger number of patients with papillary. Maybe just help us to understand, was that just the nature of the site, the number of patients who went there, or was this by design? Why did you choose to pursue this route instead of, I think, show data that are sort of more cyst-related as some of the other competitors have? Thanks.
Thank you, Oi. Dr. Certin, maybe this question can be answered by you.
I think if you look at the general population of the patients with bladder cancer, I think that approximately 10% of those patients presented with carcinoma in situ. As I told you before, our demographic data just showed reflects what actually happened in this population. I suppose Dr. Lotan will endorse me on this one. The first enrollment in this study was by the end of October last year, so we're just six months in the study. I think it's just the beginning of the study, and it's very, very initial data what we are showing up. Of course, the main purpose is to enroll more patients with carcinoma in situ. For this reason, we will open this study for multiple centers. At this stage, I think the demographic data of this group of patients just reflect exactly what happened in the general population.
Okay. If I can follow up, how do you sort of view the data relative to some of the competing therapies, like from J&J, TAR-200, as well as the CREDO, CG's, CREDO's data that was presented as well this weekend?
I understand. I think as a urologist, as a urologist, as somebody who's not only sitting in the academical center, I think you have to have in the end design, the device, the pharmacological formulation to be able to apply in every place very easy and for the broad group of the patients, not only for some selective patients. You have to have some device. I'm talking device, what I mean, pharmacological formulation, what you can apply in every place. You don't need to have any dedicated facility to prepare, any dedicated facility to supply, any dedicated facility to keep it. In this term, you can't compare NDV-01 with any current formulations. Very easy to prepare. It's coming out with the prefill ready-to-use syringe. You can use it in every place. You don't need any dedicated facility to do it.
You can do it in every clinic, in every general urology facility. To install it, it takes less than five minutes to do it. You just put the cutter in, you put two syringes, you're done. That's just easy for everyone. You don't need to train somebody else to do it in the proper place. You don't need any special office facility. You don't need cystoscopy to take you to the device and replace with something else. I think it's just for somebody who is doing everyday practice, that's the win-win situation.
Dr. Lotan, you have a lot of experience also with other programs. Maybe you want to add to the question.
Yeah, thank you. You know, I think, first of all, a lot of people are trying to make comparison between relatively small single-arm trials. Most of these trials have 80-100 patients, and they're not randomized. I think it's not really fair to make comparisons, even though eventually, as physicians, we're going to have to make recommendations to patients based on CR rates. I think there was a question about the prevalence of CIS, which is about 10%. We do see concomitant CIS. Not unexpected to see three patients out of 26. That sort of falls within the typical incidence for carcinoma in situ. I would say that intravesical gemcitabine docetaxel is commonly used in academic centers in the US based on mostly retrospective studies and as off-label use.
Even though the results for intravesical gemcitabine are promising based on the retrospective data, we're always challenged with the fact that you need a cancer center pharmacy to mix it. We can't mix it without a hood. That is one of the reasons that intravesical gemcitabine docetaxel, and even intravesical chemotherapy at all, is not widely used in the community setting. One of the main advantages here is that we have a combination of drugs that historically has worked quite well, anywhere from chemoablation to adjuvant therapy for intermediate or high-risk disease, but was difficult to get access to in the US market because of the lack of cancer center pharmacies. This is a formulation that would be readily available to community urologists as well as academic urologists. I can't mix it in my office either.
I still have to wait for it from a cancer center pharmacy. That is the promise of the medication. The added bonus is that we think that prolonged exposure would be beneficial. If you look, for example, at TAR-200, it is gemcitabine with prolonged exposure from a device. This would be a combination, which we think usually works better than a single agent, and also providing prolonged exposure rather than a one-hour to two-hour dose that sits there during installation. Obviously, not recommending any comparisons at this point, but the data is promising, and there are a lot of potential advantages in terms of administration.
Sorry. Just another. Was the safety, as you expected, see anything that's out of the ordinary or anything to that effect? At least based on what you seem to present, it seems fine with us, but just.
Yeah, that's exactly the point. Yeah, that's what we presented. That's our real data. You can see just the main complaint of those patients is some dysuria, a very mild one, which completely disappeared after two days. You can see in every patient who underwent any procedure on the urethra, like you put the catheter inside, some of the patients have a dysuria. I suppose that we put the pharmacological formulation there, but the dysuria was very mild. None of the patients so far required any additional treatment in order to get rid of it. We did not see any systemic effects in any of our patients, which is very good proof that the material is very safe.
Can I ask Dr. Lotan a follow-up question? Can you speak a bit about the community doctors and perhaps the need for efficiency and how this could play into that? I think you mentioned some of that already. Just wanted to, relative to the other therapies that will come to market or that's already on the market.
Sure. I mean, I think that at least for most physicians, access is the most important thing. If you look at trials like Moonrise One and Pivot Six, they're enrolling extremely fast. That's because there are no competitors, even commercially in the community, which are readily accessible. Intravesical chemotherapy, which is recommended in the guidelines, is not readily accessible because community offices don't have ways of mixing the drugs. We can mix BCG, which comes in a powder, in our clinics, but we cannot mix chemotherapy, which requires a hood. It is very important for our community urologists to have access to a drug. Medical oncologists who do have access to chemotherapy don't give intravesical therapies. They're not familiar with placing catheters. For them, it's technically challenging and not familiar for them.
We have sort of a gap where we have drugs that we think we recommend in the guidelines, and yet no access to them. The accessibility is probably going to be the most important aspect of this drug. It can be given in two syringes and instilled through a catheter placement. That's going to make it very easy. Probably the most important thing for our community urologists is to be able to get their hands on and deliver the drugs.
Okay. Thank you.
Thank you, Oi.
Yes, thank you for the questions, Oi. Our next question comes from Mark Goodman at Leerink. He's asking, could you please provide some color on the market opportunity, such as size, treatment landscape, and competition, please?
Dr. Lotan, maybe this one is for you.
Sure. You know, I think that by and large, there's various potential applications to this drug. Chemoablation is something that's sort of a newer paradigm that could be explored. There have been multiple studies published on chemoablation using intravesical chemotherapy. It's not really been heavily utilized, but there has been an increasing awareness of the risk of TURBT, both from a standpoint of going under anesthesia with elderly patients, as well as the potential risk for increased risk for dementia from repeated applications of anesthesia. People are trying to avoid doing as many TURBTs. There's also risk of bleeding and perforation that we want to avoid. Especially in patients with low-risk or intermediate-risk low-grade cancers, a chemoablation is something that could be a potential use. There aren't really other drugs currently approved in that setting. Urogen has obviously done a trial called Envision in that setting.
It hasn't gone to the FDA yet. That's a single agent with mitomycin. That could be a potential competitor, but on the other hand, a dual agent could potentially be more effective. In terms of adjuvant therapies, chemotherapy, as I talked about, is commonly used in academic centers, but difficult to access. That probably represents about 30-40% of all prevalent bladder cancers. Probably over 100,000 patients have recurrent low-grade tumors. Those patients don't typically die of their disease, so they do continue to have recurrences throughout their life. Agents that will reduce recurrence in that population that are accessible to community urologists are going to be quite important.
Finally, as you see the presentations about BCG unresponsive disease, many people are using gemcitabine docetaxel in that setting, in large part because even the best presentations that came out for TAR-200 and CREDO imaging had about a 40-45% durability response at one year. Likely, there's going to be room for several lines of therapy, especially in patients with carcinoma in situ. You know, I think that on one hand, this is a new agent and offers some advantages in terms of delivery and in terms of having a much longer presence in the bladder, up to 10 days rather than one to two hours. On the other hand, we've been using intravesical chemotherapies for years. They're safe. They do have good effectiveness in general.
It is not like we're starting from scratch in terms of just a whole new formulation that we do not know will work.
Thank you, Dr. Lotan. Hope this answered the question.
Great. Thank you both. Our next question comes from Andres Maldonado at HC Wainwright. Please go ahead, Andres.
Hi, guys. Thank you for hosting this. Very helpful. And thanks for taking my question. A few from us. Number one, over the years, we've spoken to a number of urologists and have detected a true bifurcation of the original results that I guess were founded by Dr. Michael O'Donnell, who really started the gemdosi kind of angle to treat NMIBC. The first question is, for those urologists that kind of are a little bit more skeptical on the gemdosi regimen's place in NMIBC, you know, what do you have to say to them to win them over? What are they missing? I have a few follow-ups.
Yeah, Dr. Lotan, maybe you should answer this one too.
Yeah. I mean, so it's interesting. You know, I think when you go to academic meetings, you know, I think the main concern about gemdosi is a lack of prospective data in a true clinical trial sense, that most of the data is retrospective. Part of the reason for that has been that no company has sort of commercialized gemdosi and done prospective trials like the other agents. I think there's appropriate skepticism when you look at retrospective data and try to compare it to historical controls. Similarly, there is some skepticism with non-randomized trials in the BCG unresponsive space as well, where you hear people saying, "Well, how do you know that this is better than another agent?" I think that one of the important components of this drug is that there will be needed or it'll be necessary to have prospective data.
I think that will increase the level of confidence with it rather than relying on retrospective studies, which I think appropriately led to some concern. The second point that I'll make briefly is that many community urologists can't get their hands on the drug, and so they don't have any experience with treating patients with intravesical gemcitabine. I would say that the vast majority of academic urologists use it quite frequently. In fact, despite the fact that I have clinical trials and available agents like Adstiladrin and Jelmyto, I still use quite a bit more gemcitabine than I do either of these agents. We have a lot more familiarity with these agents than with the newer ones. I think if you have access to it and you are able to use it, you feel much more comfortable.
Sure. Thank you. Very helpful. The second question is, you know, in a hypothetical treatment landscape where CREDO and TAR-200 are approved, given that TAR-200 uses gemcitabine, what does that say for this product in terms of, is there a chance for resensitization given that it's a combination with docetaxel and with a secondary chemotherapy? Furthermore, CREDO announced CG Oncology announced that CREDO will now be studied in combination with gemcitabine. Naturally, does this exclude these patient populations? Can you help us just fill the gaps to where you see the best fit in this scenario?
Yeah, Dr. Lotan.
Yeah.
For you as well.
Yeah. No, I understand. First of all, I'm not sure that resensitization is sort of the appropriate terminology here. I think the question is, why do half the patients become resistant or recur despite getting single agent gemcitabine within the first year? We don't really have sufficient data to understand any mechanisms of that, nor do we understand why the immune therapies don't work well long-term either. Clearly, we don't have sort of a permanent tail on any of these drugs. You can even look at five-year data now for Adstiladrin. We were part of the phase two and phase three, and only about 9% of CIS patients are disease-free at five years. We don't see sort of extremely long-term cures. We just see recurrences. I suppose I don't have enough data to sort of explain one or the other.
I think in the question of sequencing, which I think is what you're suggesting of, can you use gemdosi in a patient who had gemcitabine previously? We do that fairly routinely in patients with intermediate-risk disease, at least in academic centers. We don't give everybody gemdosi right off the bat just because it's a little bit more intensive. We usually give single agent gemcitabine. If they don't respond, then we usually give gemdosi and still see a response. My personal experience is that you can get a benefit with dual drugs when a single agent doesn't work, but there's certainly no data post-TAR-200 for any agent, much less this combination. I think in the future, though, we will start seeing how well these drugs perform in second and third line, but that's going to take some time.
The only comment I would say is that, you know, I suspect that if people have access to drugs, you know, they'll have to decide later on how they want to sequence them best and whether or not they think that a dual agent is going to be better to start off with than a single agent.
Great. Very helpful. If I can ask another question, help us contextualize, you know, the pecking order of where this therapy ranks in terms of ease of administration. We've heard a lot of, you know, a lot of companies spinning on their drugs saying that, you know, this can be a plug and play into normal urology practices. I mean, given that this is really a disease that is majority treated by community urologists, I mean, I understand that the technology is supposed to aid in the helping of urologists being able to handle a chemotherapy agent. You know, can you talk a little bit about where this ranks in terms of ease of administration is the question?
Sure. Maybe we would love to hear the opinion of both Dr. Boris and Dr. Lotan as Dr. Chen is using the drug in the clinical trial. It would be interesting to have both points of view.
Sure. Listen, I'm obviously biased. We have used this and we install it for over the period of six months. Just Dr. Relmada will just take forward from them. I just can tell you that, you know, in terms of the urology practice, the general urology, you don't need to train somebody else. As I told before, it's very easy to install it. It takes approximately five minutes to do it. In my practice, the residents, the nurse practitioner can do it very easily. You don't need any dedicated facility to do it. It should be very easy for any urologist working in community center, community practice, or academic practice will be the same.
Yeah. I mean, I guess I can comment because I was part of Sunrise One, so I've instilled TAR-200 on multiple occasions.
On one hand, I would say if you're a urologist and you're facile with a cystoscope and graspers, it's easy to remove and instill. On the other hand, you have to do it, or at least a trained PA has to do it. A nurse cannot do it. The convenience, for example, for TAR-200 is every three weeks, but somebody with experience has to be present to do it. You just can't have your nurse do it. Adstiladrin has the benefit of only every three months, but it has to be defrosted over three hours. Community urologists would have to buy a minus 80 freezer. They would have to have delivery of it. We, in fact, don't start, you can't refreeze it. You can't start, I don't defrost it until I see the patient and make sure he's okay.
Because if the patient doesn't show up, then it's a $60,000 dose you can't do anything with. We literally will wait, ask the patient how they're doing, make sure they don't have an infection or a lot of symptoms. It's also one dose, so we're very concerned that if they don't hold it for an hour, what are we going to do? Some of these patients with BCG treatment have bladders with a lot of frequency and urgency. We actually pre-medicate with anticholinergics for several days so that they can actually hold that one dose. If they urinate it out after 15, 30 minutes, what are you going to do? You can't treat them for another three months. You don't know if you had the effectiveness. The convenience is the single use every three months.
The inconvenience is having the freezer and having to defrost it over three to four hours. As far as other drugs, you know, the CREDO imaging can be given by a nurse, but it's once weekly for six weeks. This is every other week. I don't know that there's a huge difference. I know that when you talk to CG Oncology and Sunrise and J&J, they're trying to compare each other because their efficacy is very similar. There is a lot of discussion about how inconvenient is it to have a cystoscopy and a procedure placed versus weekly treatments. I'm not sure if that's as critical, but certainly this drug, being able to be given by a nurse in, you know, 10 minutes, the main advantage over other chemotherapy is you don't need a hood, and it's safe to deliver and can be done very quickly.
Thank you very much.
Thank you, Andres.
Our next question comes from Leland Gershell at Oppenheimer. Please go ahead, Leland.
Oh, great. Good afternoon. Thanks for these data and discussion. Dr. Lotan, question for you here, maybe more kind of a mechanistic question and may relate to kind of sequencing down the road as these agents become available. You know, we're seeing in the high-risk NMIBC space, you know, sort of the immunotherapeutic approaches and then the chemotherapeutic approaches. One could argue that, you know, the chemo approaches may be potentially harmful or working against the immunotherapeutic approaches given that they may be, you know, destroying some of the components of the immune system that could be actively working to destroy tumor. Just wondering if that could affect how urologists may think about sequencing these agents, you know, as NDV-01 comes forward and then also, of course, the TAR-200 and so forth. I have a follow-up. Thank you.
Sure. I appreciate that. You know, I think there's a lot of basic science that we do not understand. One of the big questions I had when we started doing the FKD Adstiladrin trials is we had, you know, we had had studies with BCG plus interferon that were not better than BCG many years ago. We take a patient who had already gotten BCG and we're giving them more interferon, just happens to last for, you know, 7 to 10 days. How is that going to even work? I would say that I've tried to learn and forgotten immunology about three different times in my career as new agents have come on. We have not been able to personalize medicine yet. If you have a patient who is BCG unresponsive, we don't understand the microenvironment to see do they have a fatigued immune system?
Does it make sense to give any immune agent now, you know, like an IL-15 agonist or interferon or, you know, NGENE's IL-12? Who knows? We have not been able to say in that patient, if it's immune depleted, cold tumor, maybe chemotherapy makes a lot more sense. We don't know if giving a virus plus a chemotherapy makes sense at all. We don't know if giving a virus that stimulates the immune system and kills cells makes sense. It is an important question to ask, but we don't have a perfect answer. We know that certain patients who are immunosuppressed and even patients over the age of 80 don't respond as well to BCG in the first place.
It'll be interesting to see what the results of the BRIDGE trial, which is a cooperative group trial that's almost done enrolling, comparing gemdosi to BCG in the BCG naive setting, because maybe it's best to give the chemotherapy upfront before the immune system is, you know, impacted at all, and then give the immune therapies later. I think if anybody's really being honest, we just do not understand very well how to sequence, who should get what type of therapy. My personal belief is that you can't just give two or three or four lines of immune therapy and then hope that suddenly the immune system will kick in. Maybe we'll find that alternating chemotherapy with immune system just to give your immune system a chance to rest or, you know, revive itself might be the best strategy.
It is way too early to figure that out. Hopefully, my career will be long enough so we know.
Got it. Got it. Yeah, you know, for the Relmada team, just curious, as this trial presumably continues, you'll have further follow-up. Should we expect to see another interim from this trial later this year? Could that be at SUO or perhaps you don't, you have insurance plans? Yeah, just curious. Thanks.
Yeah, thanks, Leland. I can answer that. Yes, we will provide data at the traditional points. I believe the next one will be the six-month data that should be available for at least the 20 patients now in the June-July timeframe. We will provide updates.
Great. Thanks very much.
Great.
Great. Thank you for the questions, Leland. Our next question is, when is the next clinical update expected and when will you file for US IND?
Thanks for the question. The next update will be the six-month data, as soon as they will be available. We are planning now to have or to plan a pre-IND meeting with the FDA, and we'll propose and discuss what the potential clinical development plan is, and we will provide an update to the street as well on the conversation we'll have with the FDA. After that, we also provide the guidance when we will find the IND that will be the next step. I hope I answered your question.
Great. Thanks, Sergio. Our next question, can you contrast the technology and effectiveness versus your agent's reverse thermal gel?
Dr. Lotan, Dr. Certin? Any insight on this?
I think I can comment. I've been treating with Jelmyto for a while, but that is, you know, a temperature-based, you know, solution that dissolves over about four to six hours and then, you know, and then gets urinated out. This technology stays in place for about 10 days. One is mitomycin, and this obviously is gemcitabine docetaxel also. I would say those are the main differences. Boris, do you want to comment perhaps?
Thanks, yeah. Just, you know, I don't have any experience with the JMDA, so I'm not able to discuss. I can compare only the historical data or just the data which was published as I previously showed with the adverse effects that were negligible in our study. You know, I think we are just starting to measure the PK, and if you don't see, you don't see any, you know, any, it was a negligible concentration of the gemcitabine dose in the blood in the plasma of those patients. I don't see if also just compare our previous experience in this hydrogel formulation. If you don't see any peak values of the metabolites of gemcitabine dose in the plasma, you don't expect any systemic reaction.
I mean, our data in terms of the adverse effect as the patient reported right now are pretty good. That's what I can say. Again, I don't have any experience with different intravesical formulation. We used to have the mitomycin as a part of the integral part of instillation following TURBT. We stopped doing that because of some very serious side effects as a result of the post-operative, immediate post-operative instillation of mitomycin following the TURBT.
Thank you.
Great. Our next question, did any CIS patients require reinduction?
What we have, three patients in this study. All three patients showed complete response after three months. We do the cystoscopic examination six months on one of those patients, and we did a taken confirmatory biopsy. It happened last, it was happened like one day before I just left for AUA. Hopefully, we'll get the results when I'll be back to Jerusalem. All three patients with the in situ, all of them after three months got a confirmatory biopsy with clean of disease.
Thank you, Boris.
Great. This concludes today's Q&A session. I will now turn it back over to Sergio for closing remarks.
Thank you, Ara. Thank you, Tara. Thank you all. Before we close the call, I just would like to leave the audience with a few key takeaways. This was an important step in, you know, the evolution of Relmada in this field. We are preparing to enter the registration studies for NDV-01. The non-muscle invasive bladder cancer is a very large opportunity. In the US only, there is a prevalence of around 600,000 patients. There are treatments available, but the options are still limited as there is a considerable amount of patients that do not respond to all the options that are available. Today we presented the three-month phase two data for NDV-01, and it is a sustained release formulation of gemcitabine and docetaxel, so gemdoce.
The data presented showed that 90% of the patients treated with NDV-01 achieved high-grade disease-free status at any time point following the treatment, including 88% high-grade recurrence-free survival in papillary patients and 100% complete response in patients with carcinoma in situ. We believe that NDV-01 has the potential to become a class-leading therapy for NMIBC and across a wide spectrum of patients and based on the compelling proof of concept that we have shown today. We are very excited about advancing this, you know, differentiated ready-to-use gemcitabine/docetaxel formulation and to improve patients' outcome and expand, you know, the treatment option for NMIBC. With that said, thank you very much to all. On behalf of the management team of Relmada, I want to thank you for joining this call. I will turn the call back to Tara.
Thank you, Sergio. At this time, the webinar has ended. You may now disconnect.