Recce Pharma R327G Phase 3 trial reaches key milestone

There is an overwhelming efficacy signal present. Uh patient infections cured, patient infections significantly improved.

Rey pharmaceuticals, ASX Ticker RCE is developing a new class of synthetic anti-infectives designed to tackle antibiotic resistant superbugs. The company has announced that an independent committee will review data from its phase three trial of a topical gel for diabetic foot infections. Here to tell us more is chief executive, James Graham. James, welcome back.

Hi, Lauren, good to be with you.

Now firstly, can you give us an overview of the Phase 3 trial of R327G in Indonesia?

Yes, so this trial is focused upon the unmet medical need of diabetic foot ulcer infections. In fact, Indonesia or the ASEAN Group of countries has an 11% diabetes rate. And there are currently no therapies approved specifically for the treatment of diabetic foot ulcer infections. So in the case of ASEAN, you've got 880 million people, 11% having diabetes. Half of those will develop a diabetic ulcer, and about 80% of those ulcers become infected. So this is positioned to be the first standard of care for that treatment, and if successful could be approved uh at least into Indonesia and the into that region as as early as early next year.

Now, data from 75 patients has now gone to the independent data monitoring Committee or DMC. Can you talk us through what the DMC does and why this is such an important milestone?

It's very significant. So firstly, the recommendation to submit or un unblind this data before the data management committee is based upon a review of both local and international infectious disease experts. So the blinded study data, whilst technically blinded in its fashion, you really can see what is going on. You just can't necessarily put your finger exactly on what is placebo and what is active. You let the data instead indicate that to you. So even in that review of the blinded data, uh there is an overwhelming efficacy signal present. Uh patient infections cured, patient infections significantly improved, and then of course other parameters as well as the positive safety profile. So this now goes towards that or to that DMC or has gone I should say, and they will come back with their findings. Interestingly, if their findings are positive, they may recommend that the study could achieve its primary endpoints where it is and to submit for approval. They may recommend the study continue, they may recommend a number of things, but it's a very positive step in the right direction.

While the data is still blinded, a review by clinical experts and a statistician pointed to strong efficacy and safety. What did that review look like and what could the DMC recommend?

Yes, so really the study data itself does indicate a significant efficacy signal, uh whilst of course maintaining a safety profile. Um, we can't say for sure whether that signal is in the placebo group or the active group, but I think we can use educated minds to consider which one it may be. So when that data is unblinded, we'll have a sure thing on on what that looks like. Uh and and we'll also have a recommendation. Uh we have an expedited regulatory review status with the Indonesian regulator, BPOM or Baden pom as they're known. and we would be in a position to make a regulatory submission assuming success, or in a position to carry the study forth in in whatever otherwise form.

You mentioned diabetic foot infections is a significant global healthcare challenge with substantial unmet need. How big is the market opportunity?

Yeah, look, so they they define the market of around 6 billion US dollars in size. Um if we bring it back to Australia by example, there's 10 and a half thousand hospitalizations in Australia each year for diabetic foot ulcer in ulcers, just the ulcer itself. And around 45% of those result in amputation. Why? Because they can't control the infection. So you can imagine the pharma economic burden, of course to the hospital, that learn the toll that takes on the patients. So this is a as a gel formulation is applied directly onto the ulcer or the infected uh diabetic ulcer itself. Uh it works broader than any other antibiotic known to date, which is important for killing any type of bacterial species that may be present, of course, leading to better patient outcomes.

And are there any updates on Rey's anti-infective pipeline?

Yeah, so it really is a pipeline because yes, we have one study in Indonesia. That study, uh if successful is approval across the ASEAN Group of countries. and the same study data pack is approval into the Middle East. and we have a leading pharmaceutical company uh for a licensing term sheet as as announced in the background on that. Back here in Australia, we're focused upon the US FDA. So a phase three running for that same indication of diabetic foot ulcer infections. That would be however submitted uh to the US FDA assuming success at the end of next year. In the background, we have three US Department of Defense programs, uh burn wound infections, surgical wound infections, chemical countermeasure threats, things like anthrax, and the plague, in fact, the plague quite recently became a bit topical. So a lot of activity, it's really a platform technology and and we're pushing it forth.

And lastly, the DMC is expected to meet as soon as mid November and R3 27 already has a FDA fast track status if you mentioned. So what should shareholders expect over the next few months?

Well, we'll await their feedback. So they're they're reviewing in their expert capacity uh and from from the uh their perspective, there there would obviously be an update uh and we we'll look forward to that.

James, thank you so much for the update.

Many thanks.