Recce Pharmaceuticals Announces Safety Committee Approves High Dose of 4,000mg in Phase I/II Trial of RECCE 327 for Urinary Tract Infections and Urosepsis

• Independent Safety Committee approves increase of RECCE^® 327 (R327) dose to 4,000mg intravenously (IV) over 30 minutes for six subjects, with dosing to start in near weeks
• R327 dosed at 3,000mg has successfully been tested at various infusion times (15, 20, 30, 45 minutes, and 1 hour)
• Minimum Inhibitory Concentration (MIC) activity identified among existing clinical samples, a dose optimization exercise for regulatory purposes
  

SYDNEY, Australia, April 30, 2024 (GLOBE NEWSWIRE) -- Recce Pharmaceuticals Ltd. (ASX: RCE, FSE: R9Q), (the Company), the Company developing a new class of synthetic anti-infectives, today announced an Independent Safety Committee approved an increase in dosing to 4,000mg over a fast infusion of 30 minutes in a Phase I/II trial evaluating its lead candidate, RECCE^® 327 (R327).

"We're thrilled the independent safety committee has unanimously clearly an increased R327 dose to 4,000mg, over a 30-minute fast IV infusion," said James Graham, Chief Executive Officer of Recce Pharmaceuticals. "The ability to administer high concentrations of a broad-spectrum anti-infective underscores the potential of a novel treatment for millions of patients worldwide with urinary tract infections or urosepsis each year."

The Company has now dosed 3,000mg at multiple infusion times: 15, 20, 30, 45 minutes, and 1 hour. Dosing has successfully achieved Minimum Inhibitory Concentration (MIC) activity among existing clinical samples. The Company has identified 30 minutes as the potential optimum infusion time and increased to a higher concentration as per regulatory expectations to investigate R327's high concentration potential.

The efficacy of R327 via IV administration will be made available at the completion of this trial in line with the study protocol. In a parallel clinical program, R327 was applied topically against diabetic foot ulcer infections and recently demonstrated its potential against a broad range of antibiotic-resistant infections.

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
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Andrew Geddes
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LifeSci Communications
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Guillame van Renterghem
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