Recce Pharmaceuticals Finishes Dosing Another Cohort in Phase I/II UTI/Urosepsis Trial

Recce Pharmaceuticals Ltd. (ASX:RCE, FSE:R9Q), a company focused on developing a new class of synthetic anti-infectives, announced on June 12, 2024, that it had successfully completed dosing another cohort in its Phase I/II clinical trial for urinary tract infections (UTIs) and urosepsis. This trial is evaluating the effectiveness of RECCE® 327 (R327) administered at accelerated infusion rates.

James Graham, CEO of Recce Pharmaceuticals, revealed that a 4,000mg dose of R327 had been administered over a rapid 20-minute infusion to all participants, marking the highest dosage achieved so far in this clinical trial. Graham emphasized that this milestone is a critical step towards establishing R327 as a leading treatment option for patients suffering from UTIs and urosepsis.

An Independent Safety Committee will review the comprehensive data collected from the six-subject cohort. Preliminary results from this analysis are expected to be available in the upcoming weeks. This data is anticipated to play a significant role in advancing to a Phase II trial focused on assessing the efficacy of R327 for treating UTIs and urosepsis. The aim is to potentially position R327 as a frontline treatment in the medical community.

Administering antibiotics through rapid intravenous infusions has proven to be both a safe and effective approach, significantly improving patient care, reducing waiting times, and easing the workload on nursing staff worldwide. The full set of data demonstrating the efficacy of R327 through intravenous administration will be disclosed upon completion of the trial, adhering to the study protocol.

Recce Pharmaceuticals Ltd. is dedicated to addressing the urgent global health issues posed by antibiotic-resistant superbugs and emerging viral pathogens. The company's anti-infective pipeline includes three patented and broad-spectrum synthetic polymer anti-infectives. These are RECCE® 327 (R327) for intravenous and topical treatment of severe bacterial infections, RECCE® 435 (R435) for oral treatment of bacterial infections, and RECCE® 529 (R529) targeting viral infections. The multi-layered mechanisms of action of Recce’s anti-infectives offer the potential to overcome bacterial and viral resistance, a significant challenge in current antibiotic treatments.

The World Health Organization (WHO) has recognized the importance of Recce’s efforts by including R327, R435, and R529 in its list of antibacterial products in clinical development for priority pathogens. Furthermore, the U.S. Food and Drug Administration (FDA) has granted R327 the Qualified Infectious Disease Product designation under the Generating Antibiotic Initiatives Now (GAIN) Act. This designation provides Fast Track status and offers 10 years of market exclusivity following approval. Additionally, R327 is listed on The Pew Charitable Trusts’ Global New Antibiotics in Development Pipeline as the only synthetic polymer and sepsis drug candidate currently in development.

Recce Pharmaceuticals fully owns its automated manufacturing facilities, which support ongoing clinical trials. The company's anti-infective pipeline aims to meet synergistic, unmet medical needs by leveraging its innovative technologies.

By making these advances, Recce Pharmaceuticals is positioned to make significant contributions to the global fight against antimicrobial resistance and to provide new, effective treatments for challenging infections. The company remains committed to advancing its clinical programs and bringing new solutions to the market to address these critical health challenges.