Recce Pharmaceuticals Advances Phase 3 Trial for Diabetic Foot Infection Gel in Indonesia

Highlights

• Milestone Approval: Recce Pharmaceuticals gains Indonesian regulatory and ethics approval for Phase 3 trial of its gel, RECCE 327 (R327G).
• Focus on Diabetes: Indonesia’s diabetes crisis underscores the urgency, with nearly 20 million affected in 2021.
• Innovative Treatment: R327G targets diabetic foot infections (DFIs), a leading cause of nontraumatic amputations.

Sydney-based Recce Pharmaceuticals Ltd (ASX:RCE) has reached a pivotal moment in its mission to address diabetic foot infections (DFIs). The company has secured approval from Indonesia’s Drug and Food Regulatory Authority (Badan POM) to proceed with a Registrational Phase 3 clinical trial for its innovative topical gel, RECCE 327 (R327G).

The trial, set to begin this quarter, also received human ethics committee approval to commence patient dosing. This alignment positions Recce to make significant progress in a region with a critical need for effective diabetes-related treatments.

Why Indonesia? A Diabetes Epidemic
Indonesia has one of the world’s largest populations of people living with diabetes, with cases rising steadily since the 1980s. According to the International Diabetes Federation (IDF), over 19 million Indonesians (10.6% of the population) were affected by diabetes mellitus in 2021. That number is projected to surpass 23 million by 2030.

A staggering 73.7% of diabetes cases in Indonesia remain undiagnosed, contributing to severe complications like DFIs. DFIs, which affect approximately 15% of diabetes patients, are the most common cause of nontraumatic foot amputations. These infections, often polymicrobial in nature, can involve pathogens such as S. aureus, P. aeruginosa, and E. coli.

The Promise of RECCE 327
R327G is a topical gel developed to treat bacterial infections, including DFIs, burns, and surgical wounds. In preclinical studies, R327 demonstrated strong antibacterial activity against resistant strains like Methicillin-resistant Staphylococcus aureus (MRSA).

This promising gel is part of Recce’s broader anti-infective portfolio, which includes ongoing Phase I/II trials for a topical spray variant targeting infected burn wounds. Early data has shown significant benefits, including reduced swelling, tissue penetration to combat underlying infections, and healthy skin regeneration.

Recce CEO James Graham emphasized the importance of the trial in advancing the gel’s commercialization. "This Phase 3 trial marks an important milestone for our company and reinforces our commitment to developing treatments for critical unmet medical needs," he said.

Expanding Assessment and Impact
R327G’s journey has included a Phase I/II proof-of-concept trial in South West Sydney to evaluate its safety and efficacy for mild diabetic foot infections. Building on these results, the Indonesian trial aims to be one of the world’s largest DFI studies and the first of its kind in the country.

Beyond addressing a major healthcare challenge in Indonesia, the trial strengthens Recce’s position in the global pharmaceutical market and highlights its ability to contribute to innovative solutions for infectious diseases.

Market Outlook
Recce Pharmaceuticals is trading at 48 cents at the time of writing on 9 December 2024, 2.13% higher than previous close.