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

• Four healthy subjects dosed with RECCE^® 327 at 3,000mg over 20 minutes
• Data received from this cohort will support preparations for a Phase II trial

SYDNEY, Australia, March 19, 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 completed dosing healthy subjects in the latest cohort of its Phase I/II trial, evaluating its lead candidate, RECCE^® 327 (R327), at fast infusion rates.

“Completing dosing of our latest cohort marks another milestone in our journey toward advancing R327 as a potential frontline treatment for patients with UTIs or urosepsis,” said James Graham, Chief Executive Officer of Recce Pharmaceuticals. “We are dedicated to delivering impactful solutions to combat infectious diseases and improve global health outcomes.”

An Independent Safety Committee will now review and evaluate the comprehensive data from the 4-subject cohort. Recruitment for the next cohort is underway.

Data from this trial is expected to pave the way for a Phase II trial to establish the potential of R327 as a frontline treatment for patients with UTIs or urosepsis. The administration of antibiotics via rapid intravenous infusions is a proven safe and effective method of administration, impacting patient treatment, wait times, and nursing workloads globally.

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
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