Recce Pharmaceuticals' RECCE 327 Topical Gel Receives Indonesian Approval for Phase 3 Diabetic Foot Infection Trial
核心洞察
Recce Pharmaceuticals (搜索) has received approval from Indonesia's Badan POM to begin a Phase 3 trial of RECCE 327 topical gel for diabetic foot infections (搜索).
The trial will be a double-blinded, placebo-controlled study enrolling up to 300 patients across Indonesia, with results expected in late 2025.
This trial is supported by key Indonesian stakeholders and aligns with Indonesia's mission to enhance healthcare outcomes for its population.
Recce Pharmaceuticals (搜索) Ltd has secured approval from the Indonesian Drug and Food Regulatory Authority, Badan POM (BPOM), to commence a Phase 3 registrational trial of RECCE® 327 (R327G) topical gel for treating diabetic foot infections (搜索) (DFIs). This development marks a significant step forward in addressing the urgent need for innovative therapies in Indonesia, which has a large population of adults living with diabetes (搜索).
The approval follows the green light from the human ethics committee to start patient dosing, ensuring Recce's clinical research adheres to Indonesian regulatory and ethical standards. The company is on track to begin the Phase 3 trial this quarter.
Trial Design and Objectives
The Phase 3 trial is designed as a double-blinded, placebo-controlled study to evaluate the efficacy and safety of R327G in treating DFIs. It aims to enroll up to 300 patients, with 200 receiving R327G and 100 receiving a placebo. The trial is expected to last approximately 12 months, with results anticipated by late 2025. Recce projects regulatory approval and commercial launch in the first half of 2026.
Addressing an Unmet Need
With over 19.5 million adults in Indonesia living with diabetes (搜索), the need for advanced treatments for diabetes-related infections is critical. Diabetic foot infections (搜索) represent a significant challenge, often leading to severe complications. This Phase 3 trial is one of the largest DFI studies globally and the first of its kind in Indonesia.
Support and Collaboration
The trial is made possible through the support of key Indonesian stakeholders, including the Indonesian Ministry of Health, Badan POM, PT Etana Biotechnologies (搜索), and the Australian Government. This collaboration accelerates R327G's path to commercialization. The study is estimated to cost Recce around $2 million, before factoring in the Australian government's 43.5% R&D rebate.
Company Perspective
James Graham, CEO of Recce Pharmaceuticals (搜索), stated, "The approval from the Indonesian National Drug and Food Authority to initiate this pivotal Phase 3 trial in Recce’s clinical development is a significant achievement, bringing Recce closer to commercialization and profitability."
Future Plans
Recce is also in the final stages of a Phase 2 trial for acute bacterial skin and skin structure infections (搜索) (ABSSSI) in Australia and anticipates initiating a Phase 3 registrational study of R327G in Australia in the first half of 2025. This parallel program across the ASEAN region, initially focused on DFIs, allows for an expansive international strategy, bringing near-term revenue opportunities to the forefront.