Recce Pharmaceuticals Completes 5,000 RECCE 327 Doses a Week under Good Manufacturing Practice (GMP)

• Successful production of 5,000 x RECCE 327 (R327) doses per week under Good Manufacturing Practises (GMP) campaign
• R327 manufactured under GMP standards in support of current and anticipated clinical trials, demonstrating compliance with guidelines set by regulatory authorities, such as the U.S. Food and Drug Administration (FDA)

SYDNEY, Australia, April 17, 2024 (GLOBE NEWSWIRE) -- Recce Pharmaceuticals Ltd. (ASX: RCE, FSE: R9Q), (the Company), the Company developing a new class of synthetic anti-infectives, today announced the successful batch completion under Good Manufacturing Practices (GMP) for its lead candidate, RECCE 327 (R327), with the patented manufacturing process now producing 5,000 GMP doses of R327 per week.

"We are thrilled to announce the successful batch completion of human pharmaceutical grade R327, representing a crucial step forward in our mission to address the global threat of antimicrobial resistance," said Arthur Kollaras, Head of Manufacturing of Recce Pharmaceuticals.

This week, the Company temporarily transported its manufacturing equipment from its Macquarie Park Facility to a third-party cleanroom-GMP facility, where it produced an increased quantity of 5,000 R327 doses under GMP, including fill and finish, the final step of the manufacturing cycle.

The manufacturing process is normally completed in-house, where the product is then transferred to a specialist clean room facility for GMP fill and finish. Due to the increased demand for R327 required for clinical studies, producing 5,000 doses of R327 per week is a significant achievement that provides surplus sample material for current Phase 1 and Phase 2 trials and an anticipated future registrational Phase 3 study for diabetic foot ulcer infections.

This marks a first for Recce’s full-spectrum manufacturing capability, which includes demonstrating the versatile, reproducible nature of its patented manufacturing process.

GMP certification signifies compliance with rigorous guidelines set by regulatory authorities, including the U.S. Food and Drug Administration (FDA), ensuring these doses can be used in Recce's clinical trials. This progress not only emphasizes the commitment to advancing this innovative antibiotic for patients in need but also represents a significant step toward the Company’s Investigational New Drug (IND) submission.