Recce Raises A$4 Million to Advance R327 Trial in DFI

Recce Pharmaceuticals has raised A$4 million through an institutional placement to accelerate development of RECCE® 327 (R327), its investigational synthetic anti-infective. The proceeds will primarily support the ongoing Phase 3 registrational trial (ACTRN12624000527505) evaluating R327 topical gel (R327G) for diabetic foot infections (DFIs) in Indonesia, while advancing commercialization activities across ASEAN and the Middle East and North Africa (MENA). The company also plans to raise an additional A$4 million through a Share Purchase Plan, bringing the total capital raising to up to A$8 million.

RECCE 327

R327 is a synthetic anti-infective that targets bacterial adenosine triphosphate (ATP) production, disrupting cellular energy metabolism and rapidly killing bacteria through a mechanism distinct from conventional antibiotics. The candidate has been included in the World Health Organization’s List of Antibacterial Products in Clinical Development as the only ATP production disruptor and has received Qualified Infectious Disease Product (QIDP) designation from the U.S. FDA, supporting expedited development and extended market exclusivity if approved.

Phase 3 Development

The ongoing randomized, double-blind, placebo-controlled Phase 3 study plans to enroll 310 patients with mild diabetic foot infections across five sites in Indonesia. Participants receive either R327 topical gel or placebo.

The primary endpoint is clinical response assessed using the Lipsky Scale, while secondary endpoints include total wound score improvement and safety. An interim analysis is planned after 155 patients, with positive data expected to support the first regulatory submission in Indonesia. The study has received expedited regulatory review from Indonesia’s Badan POM.

The Phase 3 program follows encouraging results from the Phase II ABSSSI trial (ACTRN12621001275864), where 86% of evaluable patients achieved a successful clinical response after seven days and 93% met the primary efficacy endpoint after 14 days. R327G was generally well tolerated, with no serious adverse events reported.

Pipeline Expansion

Beyond diabetic foot infections, Recce is developing topical, intravenous and inhaled formulations of R327 for acute bacterial skin and skin structure infections (ABSSSI), urinary tract infections (UTIs), urosepsis, hospital-acquired pneumonia, ventilator-associated pneumonia, and burn wound infections.

A completed Phase I intravenous study (ACTRN12621001518897) showed R327 was generally safe and well tolerated at doses up to 6,000 mg, with no serious adverse events. Pharmacokinetic analyses demonstrated urine concentrations up to 20-fold higher than plasma levels, supporting continued development in UTIs and urosepsis.

Licensing and Market Expansion

Recce recently signed a non-binding 10-year exclusive licensing term sheet with a pharmaceutical company covering multiple MENA countries. The company expects positive Phase 3 data from Indonesia to support regulatory submissions in ASEAN and facilitate broader commercialization through regional licensing partnerships.

With fresh funding secured and a registrational study underway, the next major catalyst for Recce will be the interim Phase 3 readout, which could establish the first commercial pathway for R327 and mark an important milestone for a new class of synthetic anti-infectives targeting antimicrobial resistance.

Reference

ASX:RCE – RCE Investor Presentation