Recce Pharmaceuticals Doses First Participants in Next Phase of UTI and Urosepsis Trial

Recce Pharmaceuticals Ltd. (ASX: RCE, FSE: R9Q), based in Sydney, Australia, has made significant progress in its clinical trial for RECCE® 327 (R327), a leading candidate in their anti-infective pipeline. On May 17, 2024, the company announced that the first male and female participants were dosed at 4,000mg over a 20-minute period in the latest cohort of a Phase I/II clinical trial focused on urinary tract infections (UTIs) and urosepsis. This dose marks the highest administered so far in this trial.

The trial is evaluating the efficacy and safety of R327, a synthetic anti-infective, when administered intravenously. The study has explored various IV infusion times ranging from 15 to 45 minutes. The focus on different infusion durations aims to optimize the dose for regulatory purposes, especially considering the Minimum Inhibitory Concentration (MIC) activity of R327 against bacteria identified in existing clinical samples.

The results from this trial will provide comprehensive insights into the full therapeutic potential of R327 when delivered via IV administration. The completion of the study will align with established protocols and provide crucial data for further regulatory assessments.

Recce Pharmaceuticals is dedicated to addressing the pressing global health challenges posed by antibiotic-resistant bacteria and emerging viral pathogens. Their innovative approach involves the development of a new class of synthetic anti-infectives designed to counteract resistance mechanisms that render current antibiotics ineffective.

The company’s anti-infective portfolio includes three patented, broad-spectrum synthetic polymer compounds: RECCE® 327 (R327), RECCE® 435 (R435), and RECCE® 529 (R529). R327, which is being tested both as an intravenous and topical therapy, is targeted at treating severe infections caused by both Gram-positive and Gram-negative bacteria, including their superbug strains. R435 is developed as an oral therapy for bacterial infections, while R529 is focused on viral infections.

Recce’s anti-infectives operate through multi-layered mechanisms of action, which may provide a robust solution to overcome bacterial and viral resistance processes. This innovative approach has earned significant recognition. The World Health Organization (WHO) has included R327, R435, and R529 in its list of antibacterial products in clinical development for priority pathogens. Additionally, the U.S. Food and Drug Administration (FDA) has granted R327 Qualified Infectious Disease Product (QIDP) designation under the Generating Antibiotic Initiatives Now (GAIN) Act. This designation includes Fast Track status and offers 10 years of market exclusivity upon approval.

Furthermore, The Pew Charitable Trusts has recognized R327 in its Global New Antibiotics in Development Pipeline, highlighting it as the only synthetic polymer and sepsis drug candidate currently in development. This recognition underscores Recce’s significant contributions to the fight against antimicrobial resistance.

Recce Pharmaceuticals owns and operates its automated manufacturing processes, which support its ongoing clinical trials. This capability ensures that the company can meet the production demands necessary to advance its pipeline and address unmet medical needs effectively.

This latest milestone in the clinical trial of R327 marks a crucial step towards developing a new, effective treatment for UTIs and urosepsis, potentially offering hope to millions affected by these severe infections. The ongoing research and development efforts by Recce Pharmaceuticals continue to push the boundaries of medical science in the fight against antibiotic resistance and emerging infectious diseases.