Recce Pharmaceuticals Ltd ( ASX:RCE , OTC:RECEF ) earlier this week reached an important milestone in its Phase 3 program for RECCE® 327 Gel, with data from 75 patients in its Indonesian diabetic foot infection study submitted to an independent Data Monitoring Committee for review.
Chief executive James Graham told Proactive's Lauren Hayes that the trial was addressing a major unmet medical need, with diabetic foot infections representing a serious complication for patients with diabetes and limited treatment options available specifically for the condition.
Graham said a blinded review involving infectious disease experts had identified what he described as an "overwhelming efficacy signal", including patients whose infections had been cured or significantly improved, while maintaining a positive safety profile.
He cautioned, however, that the study remained blinded, meaning Recce could not yet determine whether the apparent efficacy signal was coming from patients treated with R327G or those receiving placebo.
The DMC review represents the key near-term catalyst for the company. Graham said the committee could recommend that the study had achieved its primary endpoints and support a move towards regulatory submission, or it could recommend that the study continue or be taken forward in another form.
Recce also has expedited regulatory review status with Indonesian regulator BPOM, which Graham said could place the company in a position to make a regulatory submission assuming a successful outcome.
Beyond the immediate trial, Graham highlighted the broader commercial opportunity in diabetic foot infections, citing an estimated global market of about US$6 billion. He said R327G was applied directly to infected ulcers and was designed to work against a broad range of bacterial species.
The company is also advancing a wider anti-infective pipeline. Graham said successful Indonesian study data could have relevance across ASEAN and potentially the Middle East, while Recce remained focused on a US development pathway for the same indication.
Additional programs backed by the US Department of Defense are targeting burn wound infections, surgical wound infections and chemical countermeasure threats including anthrax and plague.
With the DMC expected to provide feedback following a meeting that could occur as soon as mid-November 2026, investors are likely to focus closely on whether the committee recommends continued development or a potential path towards regulatory submission.
Interview highlights
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Recce Pharmaceuticals has submitted data from 75 patients in its Indonesian Phase 3 study of R327G for diabetic foot infections to an independent Data Monitoring Committee.
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James Graham said a blinded expert review showed what he described as an "overwhelming efficacy signal", including infections being cured or significantly improved, alongside a positive safety profile.
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Because the study remains blinded, Recce cannot yet determine whether the apparent efficacy signal is associated with R327G or placebo.
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The DMC could recommend moving toward regulatory submission if the data supports the study's primary endpoints, or it could recommend continuing or modifying the trial.
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Graham highlighted the significant unmet need in diabetic foot infections and cited an estimated US$6 billion market.
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He said R327G is applied topically to the infected ulcer and is designed to act broadly against bacterial species.
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Recce is also pursuing development opportunities outside Indonesia, including the US market and potential expansion into ASEAN and the Middle East.
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Graham pointed to three US Department of Defense programs involving burn wound infections, surgical wound infections and chemical countermeasure threats.
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The next major near-term catalyst is the DMC's feedback, with a meeting expected as soon as mid-November 2026.
Proactive: Recce 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 3 trial of a topical gel for diabetic foot infections. Here to tell us more is chief executive James Graham. James, welcome back.
James Graham: Hi, Lauren. Good to be with you.
Proactive: Firstly, can you give us an overview of the Phase 3 trial of R327G in Indonesia?
James Graham: Yes. This trial is focused on 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.
This is positioned to be the first standard of care for that treatment and, if successful, could be approved at least in Indonesia and into that region as early as early next year.
Proactive: 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?
James Graham: It's very significant. Firstly, the recommendation to submit this blinded data before the Data Monitoring Committee is based upon a review by both local and international infectious disease experts.
The blinded study data, while technically blinded in its fashion, really does allow you to 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.
Even in that review of the blinded data, there is an overwhelming efficacy signal present — patient infections cured, patient infections significantly improved — as well as other parameters and the positive safety profile.
So this has now gone to the DMC and the committee will come back with its findings.
Interestingly, if its findings are positive, it may recommend that the study could achieve its primary endpoints where it is and submit for approval. It may recommend the study continue. It may recommend a number of things, but it's a very positive step in the right direction.
Proactive: 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 at, and what could the DMC recommend?
James Graham: The study data itself does indicate a significant efficacy signal, while of course maintaining a safety profile.
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.
When that data is unblinded, we'll have a sure view on what that looks like, and we'll also have a recommendation.
We have an expedited regulatory review status with the Indonesian regulator, BPOM, and we would be in a position to make a regulatory submission, assuming success, or in a position to carry the study forward in whatever other form is recommended.
Proactive: You mentioned diabetic foot infections as a significant global healthcare challenge with substantial unmet need. How big is the market opportunity?
James Graham: They define the market at around US$6 billion in size.
If we bring it back to Australia by way of example, there are 10,500 hospitalisations in Australia each year for diabetic foot ulcers, and around 45% of those result in amputation.
Why? Because they can't control the infection.
You can imagine the pharmacoeconomic burden to the hospital, let alone the toll that takes on patients.
This, as a gel formulation, is applied directly onto the ulcer, or the infected diabetic ulcer itself. 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.
Proactive: Are there any updates on Recce's anti-infective pipeline?
James Graham: It really is a pipeline because, yes, we have one study in Indonesia. That study, if successful, is approval across the ASEAN group of countries, and the same study data pack is approval into the Middle East.
We have a leading pharmaceutical company with a licensing term sheet, as announced, in the background on that.
Back here in Australia, we're focused on the US FDA. A Phase 3 trial is running for that same indication of diabetic foot ulcer infections. That would, however, be submitted to the US, assuming success, at the end of next year.
In the background, we have three US Department of Defense programs covering burn wound infections, surgical wound infections and chemical countermeasure threats — things like anthrax and plague. In fact, plague quite recently became a bit topical.
So there's a lot of activity. It's really a platform technology and we push it forward.
Proactive: Lastly, the DMC is expected to meet as soon as mid-November, and R327 already has FDA Fast Track status. What should shareholders expect over the next few months?
James Graham: We'll await the committee's feedback. It's reviewing the data in its expert capacity and, from that perspective, there would obviously be an update, and we'll look forward to that.
Proactive: James, thank you so much for the update.
