Recce Pharmaceuticals Doses First Participants in Next Cohort of Phase I/II Urinary Tract Infections and Urosepsis Rapid Infusion Clinical Trial

• First participants (male/female) dosed at 4,000mg over 20 minutes, with remaining subjects to be dosed in the near future – 4,000mg highest dosage to date in this clinical trial
• RECCE^® 327 (R327) tested at four fast IV infusion times (15-mins, 20-mins, 30-mins, 45-mins) over various dosage levels
• Minimum Inhibitory Concentration (MIC) activity against bacteria already identified among existing clinical samples, a dose optimization exercise for regulatory purposes

SYDNEY, Australia, May 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 it dosed the first male and female participants at 4,000mg over 20 minutes in the next cohort of a Phase I/II urinary tract infection/urosepsis trial, evaluating its lead candidate, RECCE^® 327 (R327).

The Company has explored multiple infusion times of R327 within this study, ranging from 15-45 minutes. 4,000mg is the highest dose tested in participants in this trial. With Minimum Inhibitory Concentration (MIC) activity against bacteria already detected in existing clinical samples, increasing dose optimization becomes a pivotal exercise for regulatory compliance.

The full efficacious potential of R327 via intravenous (IV) administration will be made available at the completion of this trial in line with the study protocol.

More information on this trial can be found at the Australia New Zealand Clinical Trial Registry under the trial ID ACTRN12623000448640.

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 (R327) 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 (R435) as an orally administered therapy for bacterial infections; and RECCE^® 529 (R529) for viral infections. Through their multi-layered mechanisms of action, Recce’s anti-infectives have the potential to overcome the processes utilised by bacteria and viruses to overcome resistance – a current challenge facing existing antibiotics.

The World Health Organization (WHO) added R327, R435, and R529 to its list of antibacterial products in clinical development for priority pathogens, recognising Recce’s efforts to combat antimicrobial resistance. The FDA granted R327 Qualified Infectious Disease Product designation under the Generating Antibiotic Initiatives Now (GAIN) Act, providing Fast Track Designation and 10 years of market exclusivity post approval. R327 is also included on The Pew Charitable Trusts’ Global New Antibiotics in Development Pipeline as the sole synthetic polymer and sepsis drug candidate in development.

Recce wholly owns its automated manufacturing, supporting current clinical trials. Recce’s anti-infective pipeline aims to address synergistic, unmet medical needs by leveraging its unique technologies.

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