Recce Pharmaceuticals Ltd has commenced patient dosing in its registrational Phase 3 clinical trial of RECCE® 327 Topical Gel (R327G) for diabetic foot infections in Indonesia, marking a pivotal milestone in the development of what could become the first approved treatment specifically for this indication. The randomized, placebo-controlled study will enroll up to 310 patients across five activated clinical sites in one of the world's largest diabetic populations.
Addressing Critical Medical Need in High-Prevalence Market
Indonesia presents a compelling clinical and commercial opportunity, with an estimated 20.9 million adults living with diabetes—representing approximately 11.3% of the nation's adult population. The clinical significance extends beyond prevalence statistics, as around 60% of diabetic foot ulcers develop infections that can escalate to sepsis, gangrene, amputation, or death.
"Thanks to the positive engagements with Indonesia's Food and Drug Authority (Badan POM), we are pleased to have successfully activated multiple leading clinical sites across Indonesia, and the Registrational Phase 3 DFI patient dosing is under way," said Recce CEO James Graham. "With R327G positioned as the first potential treatment for DFI, we see ourselves well positioned to meet the infectious disease challenges among the global rise in diabetes."
Trial Design and Regulatory Framework
The Phase 3 study employs the FDA-recognized Lipsky Scale as its primary endpoint for assessing clinical response, with secondary measures including total wound score and safety parameters. The Indonesian Drug and Food Regulatory Authority has granted expedited review status to the trial protocol, which incorporates a built-in interim analysis expected in the first quarter of 2026.
Recce expects to achieve a "highly statistically-significant positive endpoint" after dosing the first 155 patients. If the Independent Data Management Committee confirms positive outcomes after approximately half the patient cohort has been dosed, the company intends to pursue accelerated approval, positioning for a potential commercial launch by end-2026.
The study benefits from bilateral support from both Indonesian and Australian governments, as well as backing from Recce's local partner PT Etana, providing a robust regulatory and operational foundation for the trial's execution.
Building on Phase 2 Success
The Phase 3 trial builds directly on earlier Phase 2 findings that demonstrated R327G's clinical efficacy in patients with acute bacterial skin and skin structure infections, including those with diabetic foot infections. The drug was reported as "very well tolerated" with no serious safety signals observed, aligning with FDA demands for novel broad-spectrum antibiotics to address antimicrobial resistance in skin infections.
Graham confirmed that Recce designed the Phase 3 trial with minimal changes to replicate the Phase 2 findings, suggesting confidence in the treatment's therapeutic profile. Recent preclinical data further supported R327G's potential, showing accelerated burn wound healing in infection models and reinforcing its prospects as a broad-spectrum topical therapy.
Broader Pipeline and Regulatory Recognition
Beyond the lead topical formulation, Recce is advancing a comprehensive pipeline of synthetic anti-infectives targeting antimicrobial resistance. The company is developing intravenous and oral formulations of RECCE® 327, while RECCE® 435 targets bacterial infections and RECCE® 529 is in development for viral diseases.
The pipeline has secured multiple regulatory recognitions, including US FDA Fast Track Designation and 10 years of market exclusivity under the GAIN Act, as well as inclusion on the World Health Organization's antibacterial pipeline list. These designations underscore the regulatory agencies' recognition of the significant unmet medical need that Recce's anti-infective candidates aim to address.
