Yahoo Finance

Carl Spana

Thank you, Steph. I'll now go over some of the operating highlights for the quarter. Joining with our Phase 2 signal detection study BMT-801 evaluating the safety and efficacy of the co-administration of the Melanocortin-4 receptor agonist Bremelanotide with Tirzepatide, a GLP-1 GIP-1 dual agonist. This is being done in patients with generalized obesity. This study has been completed and the database has been locked. Topline data from the study will be available later this month.
The study was designed to evaluate two primary research questions. Does co-administration result in increased weight loss and can treatment with monocor4 receptor agonists be used for weight loss maintenance by blunting the weight regain the posting treating treatment.
In addition to safety, the study's primary point is percent weight loss of the combined treatment compared to placebo control at the end of the treatment. A variety of secondary endpoints such as satiety and preservation of lean body mass were also evaluated.
Our obesity and weight loss management portfolio includes both long acting Melanocortin receptor selective peptide agonist and the orally active Melanocortin-4 receptor selective small molecule PL7737. We are on track to move both programs into IMD enabling activities and clinical studies in calendar 2025.
Our novel next generation selective Melanocortin-4 receptor compounds have reduced activity at the Melanocortin-1 receptor and therefore have reduced potential to cause skin darkening. The lack of MC1 activity, the once weekly dosing or oral dosing represents significant improvements over current FDA approved Melanocortin treatments.
You can find additional information on our clinical trial at clinicalTrials.gov, and our website has recent presentations on our novels Next Generation Melanocortin-4 receptor compounds.
For OPO 8177 for selective Melanocortin-1 receptor treatment for ulcerative colitis. The phase two study remains on track for release of top line data in the first quarter of calendar 2025. In anticipation of the data, there has been a significant increase in business development discussions with potential partners which is in line with our current strategy to out license this exciting program.
In December, 2024, we released the top line data from our phase two breakout study evaluating Bremelanotide as a treatment for patients with diabetic kidney disease.
Key results from the study are that 71% of the patients in the study achieved a greater than 30% reduction in the urinary protein to creatinine ratio, and 71% of the patients had an improved or stabilized estimated glomerular filtration rate. The results validate the modulating the melanocortin system could potentially be a new therapeutic strategy and possibly.
And possibly disease modifying treatment option for people living with progressive kidney disease. The detailed results of the breakout study have been accepted for presentation at upcoming medical meeting. Based on the successful outcome of the study, we have initiated discussions with potential partners for out licensing this program, which is in line with our current strategy.
We previously announced that we are taking a multi-pronged approach to realizing the value of our [Ophthalmology] programs. In support of this, we are actively engaged in discussions with larger potential strategic partners for out licensing, investors interested in funding further development, and with peer companies concerning potential business combinations.
Before moving on to take questions, I would like to comment on our strategy. We are focusing our research and development efforts on our Melanocortin-4 Receptor obesity assets. We believe that the pharmacological treatment of obesity in the early stages of a multi-year cycle of innovation will have a market value in excess of $100 billion per year.
The Melanocortin system plays a critical role. In regulating stored energy and food intake, we strongly believe that Melanocortin receptor agonists will be an important part of the future of obesity treatment and weight loss management.
Palatin has a long-standing research effort to develop Melanocortin therapeutics that selectively activate Melanocortin-4 Receptor as treatments for obesity and weight loss maintenance. With our extensive experience in the design and development of Melanocortin and agonist for treating obesity, including two clinical studies previously completed and published. We are well positioned to be a leader in the development of Melanocortin-based therapeutics for weight loss and importantly weight loss maintenance.
Thank you for your time. We'll now open the call to questions.

Question and Answer Session

Operator

(Operator Instructions)
Joseph Pantginis, HC Wainwright.

Joseph Pantginis

Hey guys, good morning, good afternoon. So, I wanted to focus on the upcoming obesity data. I know you can't say much right now after the database locks, but first I wanted to just discuss the benchmark, and you can correct me if my numbers are wrong. So, if you look at the Tirzepatide data alone, after 8 weeks we're looking at about a 6% weight loss and maybe around 4% for placebo adjusted.
So, with that benchmark in mind, what would you consider a win for your study with regard to weight loss at 8 weeks and whether it's the same or not, what would you consider to be enough percentage weight loss to move the program forward?

Carl Spana

Well that's a good question, but maybe we think about it slightly differently.
So, the question is this is a signal detection study, so we don't are not a prior going in with some preconceived number, right? What we're looking for is a very clear signal. So, what we'd like to see in the study is that the combined arm is a higher percentage of weight loss and in addition to that, we're looking at some other key metrics,
For example, the percentage of patients that are achieving 4%,5%,6%,7% or 8%. Weight loss in that 8 week period, combined versus combined versus just appetite alone because that's a little bit more important. It's more important than a clinical question, right? If you put somebody on this, how many of them are going to get, 5% weight loss, which is really clinically meaningful and the FDA level of approval. So that's one message you're looking at.
And the second way of looking at it also is Tirzepatide is going if you think about things in 4 week increments, right, Tirzepatide monotherapy is going to, probably have its maximal effect in the 1st 4 weeks and then it's going to start to slow down, as you go forward from there. So, can we reverse that slowdown, right? Can we see more patients losing more weight, the 2nd 4 weeks versus the 1st 4 weeks when we compare the co administration versus the monotherapy arm. So, those are the three things that we're looking for. We are looking for an increase in the absolute weight on a percentage basis.
There's no number for magical number, and what I mean by that is this is not an optimized study. This is very low dose of Bremelanotide, so you know we're not we're not optimized for, necessarily to see some big jump, but I think we are certainly you know dosing high enough to get a nice clear signal.
The other point that I do want to bring up. Is really we talk about you know combination versus the monotherapy arm, but let's think about the Bremelanotide alone arm versus the placebo arm. I expect you know placebo patients that are going on the placebo, they will have weight loss in their first treatment period on their appetite, they should regain weight, and we'd really like to see if this low dose can blunt that weight regain, really speaking to the concept of weight loss maintenance. So those are kind of the three major concepts that we're looking for a signal on.

Joseph Pantginis

No, I understand totally about how you're looking at it, and it makes sense, I guess, the reason for my question is, when you look at, I guess the analysts viewpoint and investment community viewpoint, I think they're going to be, automatically comparing, right or wrong, having a, comparing against the benchmark. So, I think that's what's driving. What would be expected to be a win from a percentage standpoint, but I understand your approaches here, and it makes sense.
I guess when you look forward for the program, are there additional indications you might consider beyond sort of the broader weight loss community, any sort of orphan indications that you might consider from MCR-4 standpoint?

Carl Spana

Sure, certainly, listen, there is a, I think a growing opportunity to think about the use of melanocortin force that agonists and, in rare and orphan syndromic diseases, there are a number of mutations in the melanocortin system.
There's Prader Willi syndrome, there's Barde Bartle, and these are things though this is not unknown. I mean, the rhythm is out there. They have their products in there, but hypothalamic obesity is a very key one because that's probably the largest market opportunity.
And it's one where we think we know our new compounds coming through will be very competitive and you know that gives us a in a nice way, there's two of us in Melanocortin-4 Receptor agonism in looking at that orphan rare space, when you go to the general obesity side, although I believe this is the best mechanism, we're going to get moved into a bunch of other mechanisms that are out there. So, I think so I think we'll be focusing likely to be focusing in that rare space.

Joseph Pantginis

No, it makes sense and good luck for the upcoming data thanks a lot for the details.

Operator

Thank you. And there were no other questions at this time. I would now like to hand the call back to Dr. Carl Spana for closing remarks.

Carl Spana

So thank you, for your questions and everybody, thank you for your time. Steph and I are always grateful that you give us your time and you take meetings with us, talk about the company. We like you have a great day. It's going to be an exciting quarter for us, and we're really looking forward to. It's actually going to be exciting 2025 for us.
So you really can be more excited than what we're doing here and look forward to reporting our results out. So, from Steph and I, thank you, everybody, and have a great day and a great quarter.
Thank you.

Operator

Thank you. This does conclude today's conference. You may disconnect your lines at this time.
Thank you for your participation.