Recce Pharmaceuticals to begin Phase 3 trials in Indonesia for diabetic foot infection treatment

Recce Pharmaceuticals Limited has received ethics approval from Indonesia’s Human Research Ethics Committee to initiate Phase 3 clinical trials of its topical gel, RECCE® 327 (R327G), designed for diabetic foot infections (DFIs). This green light enables the Australian-based company to move forward with its large-scale study in Indonesia, a country with one of the world’s largest diabetes patient populations, marking a significant step toward potentially transforming diabetic wound care across the Asia-Pacific.

Ethics Approval Marks Major Step Toward Groundbreaking Treatment

Recce Pharmaceuticals’ CEO, James Graham, highlighted this ethics approval as a critical milestone in the company’s clinical development program, made possible through substantial collaboration with Indonesian government and healthcare partners. Graham expressed gratitude for the support from Indonesia, describing it as “unparalleled.” The approval represents an essential first step in a bilateral initiative, involving both Australian and Indonesian governmental support, in partnership with PT Etana Biotechnologies.

Study to Target Over 300 Patients with Potential for Market Expansion

The double-blind, placebo-controlled trial, set to launch in mid-December, will recruit up to 300 participants, with 200 receiving R327G and 100 on a placebo. Conducted over 12 months, this study is anticipated to read out results by late 2025, with regulatory submissions expected soon after. If successful, R327G could launch commercially in the first half of 2026, addressing a substantial unmet need for innovative DFI treatments in a market valued at around US$5.2 billion globally.

Indonesia’s demand is particularly high, with 11% of the population affected by diabetes and a significant proportion at risk of foot infections and related complications. Market forecasts estimate the DFI treatment sector in Indonesia to be worth around US$189 million, positioning Recce to capture a significant portion of this emerging market with potential to expand throughout ASEAN, including Malaysia, Singapore, Thailand, and the Philippines.

Addressing a Market Critical for Combating Antimicrobial Resistance

Diabetic foot infections, which affect up to half of all diabetic foot ulcers, are a major cause of complications, often leading to severe infections, gangrene, and amputation. With increasing cases of antimicrobial resistance, Recce’s new synthetic anti-infective formulation holds promise for regions facing this growing challenge. R327G’s unique polymer formulation aims to tackle resistant pathogens, positioning it as a crucial solution in both infection control and diabetic care. The World Health Organization (WHO) has recognized Recce’s work on antimicrobial-resistant infections, adding R327G to its list of antibacterial products for priority pathogens.

Significant Economic Backing and Proprietary Technology

The Phase 3 trial, budgeted at US$2 million, benefits from financial support via Australia’s 43.5% R&D rebate scheme. Recce wholly owns the intellectual property for R327G and operates an automated manufacturing process designed to sustain trial production. This setup not only supports current clinical trials but also fortifies Recce’s competitive positioning for future scale-up and distribution.

Expert Opinion on R327G’s Prospects

Clinical analysts view R327G as a promising addition to diabetic wound care options, given its potential to significantly reduce infection risks associated with diabetic ulcers. The formulation’s distinct mechanisms offer new hope in addressing the bacterial resistance that has stymied traditional antibiotics. “The anticipation surrounding R327G is justified, as it targets a niche yet expanding market that requires advanced therapeutic solutions,” noted one industry analyst specializing in diabetic care innovation.

Recce’s proprietary synthetic polymer approach provides a multi-pronged solution, tackling pathogens through various pathways, making it more difficult for bacteria to develop resistance. This advancement is expected to place Recce in a favorable position within the global biotech landscape, as the company continues to leverage its synthetic anti-infective expertise.