The company is advancing R327G, a novel synthetic anti-infective for diabetic foot infections, through a phase 3 clinical trial in Indonesia, marking a major step toward the first new anti-infective class approval in over 40 years.
Reece Pharmaceuticals CEO James Graham
Diabetic foot infections (DFIs) represent one of the most devastating complications of diabetes, responsible for significant patient suffering and immense healthcare costs worldwide. Up to half of all diabetic foot ulcers become infected, and roughly one in five severe cases lead to amputation—a life-altering outcome that carries a five-year mortality rate comparable to many forms of cancer. In Indonesia alone, more than one in ten adults live with diabetes, underscoring the urgent global need for new and effective treatments. Recce Pharmaceuticals aims to address this crisis through the development of R327G, a topical gel formulation from its innovative class of synthetic anti-infectives designed to act rapidly and resist bacterial adaptation.
Unlike traditional antibiotics that target specific bacterial structures or metabolic pathways, Recce’s R327 works by disrupting bacterial energy production at the cell surface, rapidly depleting ATP and causing irreversible bacterial death without triggering cell lysis. This broad-spectrum and universal mechanism enables R327 to kill both active and dormant bacteria, including multidrug-resistant strains. With R327G now in Phase 3 trials for DFIs and an intravenous formulation, R327, advancing in urinary tract and urosepsis studies, Recce is positioned to usher in a new era of synthetic anti-infectives—potentially redefining the global fight against antimicrobial resistance.
Recce Pharmaceuticals CEO James Graham spoke with Contagion about DFI, R327G, and the company's pipeline.
Contagion: Can you talk about the health burden for diabetic foot infections
Graham: Diabetic foot infections are among the most serious and costly complications of diabetes, often leading to lengthy hospital stays, amputation, or even death. Globally, around half of diabetic foot ulcers become infected, and roughly one in five of those severe infections result in amputation. The five-year mortality rate can reach up to 50 percent, comparable to many cancers. In Indonesia, where our phase 3 clinical trial is underway, more than one in ten adults live with diabetes, underscoring the urgent need for new treatment options. Through our new class of synthetic anti-infectives, designed to act rapidly and without signs of resistance, we aim to improve patient outcomes and help reduce the broader healthcare burden.
Contagion: R327G is being studied as a gel and IV therapy. Can you talk about where the IV treatment is in the pipeline?
Graham: The intravenous formulation of RECCE 327 (R327) has successfully completed multiple clinical trials (phase 2 and 1/2), confirming its safety and tolerability at high doses of up to 6,000 mg. The trial data also demonstrated that R327 concentrates safely in urine, up to 20 times higher than plasma, with results from these trials paving the way for R327 as a potential first-line treatment for patients suffering from UTI/Urosepsis. We now look ahead to an expanded phase 2 trial in UTI/Urosepsis to advance toward global regulatory submissions.
Contagion: R327G is part of a new class of synthetic anti-infectives—how does its mechanism differ from conventional antibiotics?
Graham: Unlike traditional antibiotics that target specific bacterial structures or metabolic pathways, R327 works through a novel mechanism that rapidly accesses and shuts down bacterial energy production at or near the cell surface. By depleting adenosine triphosphate, or ATP, R327 disrupts bacterial metabolism and causes irreversible bacterial death without inducing cell lysis.
This universal mode of action enables R327 to kill both active and resting bacteria across Gram-positive and Gram-negative strains, including those resistant to multiple antibiotics, with no loss of activity even after repeated exposures.
Contagion: Can you provide some insights on the broader anti-infective pipeline, including R435 and R529?
Graham: Beyond our clinical programs for R327G (topical gel) and R327 (intravenous), Recce continues to explore additional candidates that expand our synthetic anti-infective platform. These include R435 and R529, which represent our ongoing pre-clinical work investigating new formulations and delivery methods targeting serious infections such as hospital- and ventilator-associated pneumonias and other severe lung infections. Together, these programs complement our broad spectrum multi-asset approach to addressing the growing threat of antimicrobial resistance across infectious diseases.
Contagion: Looking ahead, with interim analysis and potential regulatory submission anticipated in 2026, what are the next strategic steps for Recce Pharmaceuticals if the phase 3 results meet your efficacy and safety goals?
Graham: If our phase 3 clinical trial in Indonesia successfully meets its endpoints, we will look to file for approval under the Expedited Regulatory Review framework with Indonesia’s Food and Drug Authority, Badan POM, in 2026. Which would allow for commercial launch and the first market approval of a new class of anti-infectives in more than 40 years. If approved, R327G would be the first topical anti-infective specifically approved for the treatment of DFI in Indonesia.
This would allow the company to then replicate submissions throughout the broader ASEAN region, Australia, the United States, and other global markets. These milestones would position Recce as a leader in synthetic anti-infectives and advance our goal of delivering R327G to patients across the broader ASEAN region and beyond.
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