Recce Pharma Completes Dosing Additional Cohort in Phase I/II UTI/Urosepsis Trial

SYDNEY, June 12, 2024 – Recce Pharmaceuticals Ltd. has successfully dosed another group of participants in its ongoing Phase I/II clinical trial for URTI/Urosepsis, utilizing their novel anti-infective agent RECCE® 327 (R327) in rapid infusion rates. This significant achievement involved administering a 4,000mg dose over a swift 20-minute infusion period, marking the highest dosage level reached in the trial to date.

James Graham, CEO of Recce Pharmaceuticals, remarked on this milestone, highlighting its importance in advancing R327 as a potential leading treatment for urinary tract infections (UTIs) and urosepsis. An Independent Safety Committee is currently reviewing the data from this six-subject cohort, with initial results anticipated in the coming weeks.

The data gathered from this trial is expected to be crucial in setting the stage for a subsequent Phase II efficacy trial focused on UTI/Urosepsis. The method of delivering antibiotics via rapid intravenous infusion has demonstrated both safety and effectiveness, significantly improving patient care by reducing wait times and easing healthcare providers' workloads globally.

Upon completion of the current trial, comprehensive data showcasing the effectiveness of R327 through intravenous administration will be disclosed, adhering to the study's protocol. Additional details about this trial can be found in the Australia New Zealand Clinical Trial Registry under the trial ID ACTRN12623000448640.

Recce Pharmaceuticals Ltd is dedicated to developing a new class of synthetic anti-infectives to address the critical global health issues posed by antibiotic-resistant bacteria and emerging viral pathogens. The company's portfolio includes three patented, broad-spectrum synthetic polymer anti-infectives. These are RECCE® 327, which is being tested both as an intravenous and topical therapy for serious bacterial infections, including those caused by superbugs; RECCE® 435, designed for oral administration to treat bacterial infections; and RECCE® 529, aimed at combating viral infections.

Recce's anti-infectives are built on multi-layered mechanisms of action, providing the potential to overcome the resistance mechanisms employed by bacteria and viruses. This innovative approach addresses a major challenge faced by current antibiotics. The World Health Organization (WHO) has acknowledged the significance of Recce's work by listing R327, R435, and R529 among antibacterial products in clinical development targeting priority pathogens.

In addition, 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 ensures Fast Track status and 10 years of market exclusivity post-approval. Furthermore, R327 has been featured in The Pew Charitable Trusts’ Global New Antibiotics in Development Pipeline as the only synthetic polymer and sepsis drug candidate currently under development.

Recce Pharmaceuticals maintains full ownership of its automated manufacturing processes, which support ongoing clinical trials. The company's anti-infective pipeline aims to address critical, unmet medical needs by leveraging its unique technologies and innovative solutions.

The continuous efforts by Recce Pharmaceuticals to advance their novel anti-infectives underscore the company's mission to address the mounting global challenge of antimicrobial resistance effectively. The progress in their clinical trials signifies a promising step forward in the fight against serious infections, with the potential to bring new, effective treatments to patients in dire need.