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.
GMP covers all aspects of production, from the starting materials, premises, and equipment to the training and personal hygiene of staff. It prevents errors that cannot be eliminated through quality control of the finished product. Without GMP, it is impossible to be sure that every unit of medicine is of the same quality as the units tested in the laboratory.1
About Recce Pharmaceuticals Ltd
Recce Pharmaceuticals Ltd (ASX: RCE, FSE: R9Q) is developing a New Class of Synthetic Anti-Infectives designed to address the urgent global health problems of antibiotic-resistant superbugs and emerging viral pathogens.
Recce’s anti-infective pipeline includes three patented, broad-spectrum, synthetic polymer anti-infectives: RECCE® 327 as an intravenous and topical therapy that is being developed for the treatment of serious and potentially life-threatening infections due to Gram-positive and Gram-negative bacteria including their superbug forms; RECCE® 435 as an orally administered therapy for bacterial infections; and RECCE® 529 for viral infections. Through their multi-layered mechanisms of action, Recce’s anti-infectives have the potential to overcome the hypercellular mutation of bacteria and viruses – the challenge of all existing antibiotics to date.
The FDA has awarded RECCE® 327 Qualified Infectious Disease Product designation under the Generating Antibiotic Initiatives Now (GAIN) Act – labelling it for Fast Track Designation, plus 10 years of market exclusivity post approval. Further to this designation, RECCE® 327 has been included on The Pew Charitable Trusts Global New Antibiotics in Development Pipeline as the world’s only synthetic polymer and sepsis drug candidate in development. RECCE® 327 is not yet market approved for use in humans with further clinical testing required to fully evaluate safety and efficacy.
Recce wholly owns its automated manufacturing, which is supporting present clinical trials. Recce’s anti-infective pipeline seeks to exploit the unique capabilities of its technologies targeting synergistic, unmet medical needs.
Corporate Contact
James Graham
Recce Pharmaceuticals Ltd
+61 (02) 9256 2571
James.graham@recce.com.au
Media & Investor Relations (AU)
Andrew Geddes
CityPR
+61 (02) 9267 4511
ageddes@citypublicrelations.com.au
Media (USA)
Michael Fitzhugh
LifeSci Communications
mfitzhugh@lifescicomms.com
Investor Relations (USA & EU)
Guillame van Renterghem
LifeSci Advisors
gvanrenterghem@lifesciadvisors.com
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