The Independent Safety Committee has approved an increase of Recce Pharmaceuticals Ltd (ASX:RCE, OTC:RECEF)’s R327 to 4,000mg intravenously (IV) over a fast infusion of 30 minutes.
The approval is for a high dose of 4,000mg in a Phase 1/2 urinary tract infection/urosepsis rapid infusion clinical trial.
R327 is part of the company’s development of a new class of synthetic anti-infectives. At 3000mg, it was successfully tested at four infusion times (15 minutes, 20 minutes, 30 minutes, 45 minutes and 1-hour).
Dosing has successfully achieved minimum inhibitory concentration (MIC) activity among existing clinical samples.
Subject recruitment is now underway for the next phase – the 4,000mg intravenously over a fast infusion of 30 minutes – and the company expects to start/complete dosing of six subjects in the coming weeks.
"We're thrilled the independent safety committee has unanimously cleared an increased R327 dose to 4,000mg, over a 30-minute fast IV infusion," CEO James Graham said.
“The high concentration potential to administer a broad spectrum anti-infective underscores the potential of a novel treatment for millions of patients worldwide that suffer from urinary tract infection/urosepsis each year.”
Potential optimum infusion time
Recce identified the 30 minute infusion time for its drug candidate R327 as optimal and has increased the concentration to meet regulatory standards, aiming to explore the drug's potential at higher concentrations.
The results from the intravenous administration of R327 will be disclosed upon the completion of the ongoing human clinical trial, adhering to the study protocol.
Simultaneously, in a separate clinical study, R327 demonstrated its effectiveness when applied topically to treat diabetic foot ulcer Infections, showing promising results against a variety of antibiotic-resistant infections.
Just last week, Recce successfully completed a batch production of 5,000 doses per week of its R327 under Good Manufacturing Practices (GMP), highlighting the company's enhanced full-spectrum manufacturing capabilities and the reproducibility of its patented process.
Anti-infective pipeline
Recce Pharmaceuticals' anti-infective pipeline features three patented, broad-spectrum, synthetic polymer anti-infectives, each designed to address significant unmet medical needs. RECCE 327, available for both intravenous and topical use, is targeted at treating serious infections caused by both Gram-positive and Gram-negative bacteria, including antibiotic-resistant 'superbug' forms. RECCE 435 is being developed as an orally administered therapy for bacterial infections, while RECCE 529 is focused on combating viral infections.
The unique multi-layered mechanisms of action of these anti-infectives are designed to address the rapid mutation rates of bacteria and viruses, a common challenge for current antibiotics. The US Food and Drug Administration (FDA) has recognised the potential of RECCE® 327, awarding it the Qualified Infectious Disease Product designation under the Generating Antibiotic Initiatives Now (GAIN) Act. This designation includes Fast Track status and guarantees 10 years of market exclusivity post-approval.
Further endorsing its innovative approach, RECCE 327 has been listed by The Pew Charitable Trusts on the Global New Antibiotics in Development Pipeline as the only synthetic polymer and sepsis drug candidate currently in development. However, RECCE 327 is not yet approved for market use in humans, with additional clinical trials needed to fully ascertain its safety and efficacy.
Recce Pharmaceuticals retains full ownership of its automated manufacturing processes, which support the ongoing clinical trials and enhance its capacity to meet critical healthcare needs through its innovative technologies.