Recce Pharmaceuticals Receives Approval for Additional Phase II Trial of RECCE® 327 Topical Gel for Diabetic Foot Infections
MWN-AI** Summary
Recce Pharmaceuticals Ltd has secured approval from the Human Research Ethics Committee (HREC) to expand its ongoing Phase II trial of RECCE® 327 Topical Gel (R327G), allowing for the inclusion of up to 20 additional patients suffering from diabetic foot infections (DFI). This strategic decision follows promising Phase II results in treating acute bacterial skin and skin-structure infections, particularly diabetic foot ulcers (DFU). Given the significant unmet medical need—where approximately 40% of patients experience ulcer recurrence within a year—the study aims to address the challenging landscape of DFI treatment.
The new cohort will continue to evaluate R327G's effectiveness, leveraging encouraging data that indicated an 86% clinical response rate after just seven days of treatment, with over 90% achieving the primary efficacy endpoint by day 14. R327G’s topical application offers a safer alternative to systemic antibiotics, which are often ineffective against such infections and come with adverse side effects.
This expanded trial will run concurrently with a planned Registrational Phase 3 trial in Indonesia for DFI and another for acute bacterial skin and skin-structure infections in Australia, both on track for H2 2025. Recce Pharmaceuticals aims to strengthen its data portfolio for future regulatory submissions while providing a critical solution for diabetic patients whose treatment options are currently limited.
The ongoing clinical developments, supported by insights from medical experts, reinforce Recce's commitment to addressing urgent health challenges presented by antibiotic-resistant infections, positioning R327G as a potential game-changer in the treatment of DFI.
MWN-AI** Analysis
Recce Pharmaceuticals Ltd (ASX: RCE) is gaining traction with its recent approval from the Human Research Ethics Committee for an additional Phase II trial of its innovative RECCE® 327 topical gel (R327G) for diabetic foot infections (DFI). With initial positive results from earlier trials showcasing an impressive clinical response rate of over 90% at 14 days, the company is on the cusp of a significant breakthrough.
Diabetic foot ulcers pose a considerable healthcare challenge, with recurrence rates of 40% within a year and escalating risks of severe health complications. The growing diabetes population, combined with the ineffectiveness of current treatments, highlights R327G’s potential market as a crucial alternative. This new study allows access for up to 20 additional patients under a compassionate use protocol, which can amplify positive outcomes while simultaneously enriching the clinical data portfolio ahead of the pivotal Phase 3 trials planned in Indonesia and Australia.
From a market perspective, investors should consider several factors: The urgency for effective DFI treatments presents a timely investment opportunity as Recce's data could attract favorable regulatory attention. Furthermore, with R327G’s designation as a Qualified Infectious Disease Product by the FDA, there’s potential for accelerated approval, enhancing potential revenue streams ahead of anticipated market exclusivity.
The parallel execution of trials and the backing of respected institutions like Barwon Health underscore the credibility and momentum of Recce within the competitive landscape of anti-infectives. As such, investors might view the current phase as a prime entry point, leveraging a diversified portfolio against emerging microbial resistance, thereby positioning Recce Pharmaceuticals as a potential leader in the evolving pharmaceutical market dedicated to combating high-stakes healthcare problems.
**MWN-AI Summary and Analysis is based on asking OpenAI to summarize and analyze this news release.
- Human Research Ethics Committee (HREC) approval received to allow up to 20 additional patients access to RECCE ® 327 Topical Gel (R327G) treatment under existing open-label study protocol
- Program enables access to R327G for diabetic foot infections (DFI), following recent positive Phase II results in acute bacterial skin and skin-structure infections (ABSSSI), including diabetic foot ulcers (DFU)
- Access focused on patients with DFU infections given the unmet medical need, as ~40% experience ulcer recurrence within a year of healing
- The study will start now, running in parallel to Registrational Phase 3 in Indonesia for DFI and planned Registrational Phase 3 for ABSSSI in Australia, on track for H2 2025
SYDNEY, April 23, 2025 (GLOBE NEWSWIRE) -- Recce Pharmaceuticals Ltd (ASX: RCE, FSE: R9Q), (Recce or the Company), a leading developer of a new class of synthetic anti-infectives, today announced it received Human Research Ethics Committee (HREC) approval to build upon its open-label Phase II trial of RECCE ® 327 Topical Gel (R327G) for the treatment of diabetic foot infections (DFI), enabling the enrollment of up to 20 additional patients.
“This approval allows us to build upon the strong clinical results of R327G and continue demonstrating its potential as a differentiated treatment for DFIs,” said James Graham, Chief Executive Officer of Recce Pharmaceuticals. “We are pleased to continue to provide access to R327G to diabetic patients in need, and to further build out our data portfolio alongside our Phase 3 programs in both Australia and Indonesia.”
The use of R327G under this protocol follows strong interest by investigators encouraged by the highly promising results of the recently released Phase II data, where R327G demonstrated, after 7 days of treatment, 86% of patients had a successful clinical response (the primary endpoint also used by the U.S. FDA). At 14 days of treatment, >90% of patients achieved a primary efficacy endpoint.
The investigators of the trial have expressed confidence in R327G as a safe and well-tolerated therapeutic, particularly in difficult-to-treat infections such as DFIs, where standard treatments often fall short. Using a gel avoids systemic (oral & IV) antibiotics with their associated adverse effects. This study offers an opportunity to further strengthen the clinical profile of R327G while addressing the urgent needs of patients currently lacking effective treatment options.
The study will start now and run in parallel with Recce’s Indonesian Phase 3 trial, which remains on track to commence shortly. This program does not impact the initiation timeline of the Registrational Phase 3 DFI study in Indonesia or the planned Registrational Phase 3 ABSSSI study in Australia. The study is designed to run in parallel and is expected to generate additional data to support future regulatory submissions. The study will be conducted by Barwon Health, further supporting the Company’s clinical momentum in Australia.
Alan W. Dunton, MD, Chief Medical Advisor and Non-Executive Director of Recce Pharmaceuticals, added, “It is important to provide additional therapeutic options to diabetic patients with infections. Recce’s compound has an optimal profile as a localised therapeutic for patients, in contrast to treatment with IV and oral antibiotics, which are often not effective and are accompanied by unwanted side effects such as diarrhea and gastrointestinal distress.”
The recurrence rate of DFI within 1 year after healing is 40%, the recurrence rate is 60% within 3?years, and 65% within 5?years. 1 The risk of a person with diabetes developing a foot infection has been estimated to be between 34% 2 and 50%. These infections can lead to sepsis, gangrene, amputation, and death. 3
About Recce Pharmaceuticals Ltd
Recce Pharmaceuticals Ltd (ASX: RCE, FSE: R9Q) is developing a New Class of Synthetic Anti-Infectives designed to address the urgent global health problems of antibiotic-resistant superbugs and emerging viral pathogens.
Recce’s anti-infective pipeline includes three patented, broad-spectrum, synthetic polymer anti-infectives: RECCE ® 327 (R327) as an intravenous and topical therapy that is being developed for the treatment of serious and potentially life-threatening infections due to Gram-positive and Gram-negative bacteria, including their superbug forms; RECCE ® 435 (R435) as an orally administered therapy for bacterial infections; and RECCE ® 529 (R529) for viral infections. Through their multi-layered mechanisms of action, Recce’s anti-infectives have the potential to overcome the processes utilised by bacteria and viruses to overcome resistance – a current challenge facing existing antibiotics.
The World Health Organization (WHO) added R327, R435, and R529 to its list of antibacterial products in clinical development for priority pathogens, recognising Recce’s efforts to combat antimicrobial resistance. The FDA granted R327 Qualified Infectious Disease Product designation under the Generating Antibiotic Initiatives Now (GAIN) Act, providing Fast Track Designation and 10 years of market exclusivity post approval. R327 is also included on The Pew Charitable Trusts’ Global New Antibiotics in Development Pipeline as the sole synthetic polymer and sepsis drug candidate in development.
Recce wholly owns its automated manufacturing, supporting current clinical trials. Recce’s anti-infective pipeline aims to address synergistic, unmet medical needs by leveraging its unique technologies.
Corporate Contact
James Graham
Recce Pharmaceuticals Ltd
+61 (02) 9256 2571
James.graham@recce.com.au
Media & Investor Relations (AU)
Andrew Geddes
CityPR
+61 (02) 9267 4511
ageddes@citypublicrelations.com.au
Media (USA)
Michael Fitzhugh
LifeSci Communications
mfitzhugh@lifescicomms.com
Investor Relations (USA & EU)
Guillame van Renterghem
LifeSci Advisors
gvanrenterghem@lifesciadvisors.com
1 https://pmc.ncbi.nlm.nih.gov/articles/PMC10088840/#iwj14017-bib-0004
2 https://www.ncbi.nlm.nih.gov/books/NBK409609/
3 https://www.uptodate.com/contents/evaluation-of-the-diabetic-foot
FAQ**
What specific criteria will the Human Research Ethics Committee (HREC) use to evaluate the safety and efficacy of R327G treatment for diabetic foot infections under Recce Pharmaceuticals Ltd RECEF's expanded study?
How does the successful clinical response rate in the Phase II trial of R327G inform the enrollment strategy for the additional patients under the HREC approval in Recce Pharmaceuticals Ltd RECEF?
What are the anticipated challenges Recce Pharmaceuticals Ltd RECEF may face in recruiting the additional patients for the DFI study, and how does HREC approval support this effort?
How does Recce Pharmaceuticals Ltd RECEF plan to integrate data from the additional patients into the existing results from the Phase II study and upcoming Phase 3 trials for regulatory submission?
**MWN-AI FAQ is based on asking OpenAI questions about Recce Pharmaceuticals Ltd (OTC: RECEF).
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