Recce Pharmaceuticals Doses Next Cohort in Phase I/II Trial of RECCE® 327 for Urinary Tract Infections and Urosepsis

• The next cohort of healthy subjects dosed at 3,000mg over 20 minutes, with the remaining subjects to be dosed over the coming days
  
• RECCE^® 327 now tested at four infusion times, achieving these timestamps in line with intended future regulatory submissions

SYDNEY, Australia, March 14, 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 next cohort of healthy subjects at 3,000mg within a fast infusion rate of 20-minutes in a Phase I/II trial evaluating its lead candidate, RECCE^® 327 (R327).

“We're pleased to continue advancing the clinical profile of R327, which has demonstrated safe and efficacious potential against a broad range of antibiotic-resistant pathogens across multiple studies,” said James Graham, Chief Executive Officer of Recce Pharmaceuticals. “We've observed efficacy when applied topically to patients with diabetic foot ulcer infections, and the additional infusion time at 3,000mg over 20 minutes in this study highlights a compelling safety profile with the potential to treat the millions of patients worldwide that suffer from UTIs or urosepsis each year.”

Recce is exploring multiple infusion times of 15, 20, 30, and 45 minutes, and 1 hour at 3,000mg, which is viewed as R327’s optimal dosing therapeutic window. The Company has established that the dose of 3,000mg, administered at varying infusion times between 15 and 60 minutes, has been proven safe in participants. The efficacy of R327 via intravenous administration will be made available at the completion of the Phase I/II 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 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 as an orally administered therapy for bacterial infections; and RECCE^® 529 for viral infections. Through their multi-layered mechanisms of action, Recce’s anti-infectives have the potential to overcome the hypercellular mutation of bacteria and viruses – the challenge of all existing antibiotics to date.

The FDA has awarded RECCE^® 327 Qualified Infectious Disease Product designation under the Generating Antibiotic Initiatives Now (GAIN) Act – labelling it for Fast Track Designation, plus 10 years of market exclusivity post approval. Further to this designation, RECCE^® 327 has been included on The Pew Charitable Trusts Global New Antibiotics in Development Pipeline as the world’s only synthetic polymer and sepsis drug candidate in development. RECCE^® 327 is not yet market approved for use in humans with further clinical testing required to fully evaluate safety and efficacy.

Recce wholly owns its automated manufacturing, which is supporting present clinical trials. Recce’s anti-infective pipeline seeks to exploit the unique capabilities of its technologies targeting synergistic, unmet medical needs.

Corporate Contact
James Graham
Recce Pharmaceuticals Ltd
+61 (02) 9256 2571
[email protected]

Media & Investor Relations (AU)
Andrew Geddes
CityPR
+61 (02) 9267 4511
[email protected]

Media (USA)
Michael Fitzhugh
LifeSci Communications
[email protected]

Investor Relations (USA & EU)
Guillame van Renterghem
LifeSci Advisors
[email protected]