RECCE® 327 Phase I/II Trial Advances with Next Dosage Cohort for UTIs and Urosepsis

Recce Pharmaceuticals Ltd, a company focused on developing synthetic anti-infectives to combat antibiotic resistance and emerging viral threats, has initiated a new phase in its clinical trials. The latest group of participants in the Phase I/II study received a 3,000mg dose of the company's lead product, RECCE® 327 (R327), in a rapid 20-minute infusion. This dosage is part of a broader strategy to test various infusion times, including 15, 30, 45 minutes, and 1 hour, to determine the optimal therapeutic window for R327.

The company's CEO, James Graham, expressed optimism about the drug's potential, noting its demonstrated safety and effectiveness against a wide array of antibiotic-resistant pathogens. He highlighted the drug's topical application in treating diabetic foot ulcer infections and the promising safety profile for treating urinary tract infections (UTIs) and urosepsis, which affect millions globally.

Recce Pharmaceuticals is also exploring R327's intravenous administration, with the results expected upon the trial's conclusion. The trial is registered with the Australia New Zealand Clinical Trial Registry under the ID ACTRN12623000448640.

The company's anti-infective pipeline comprises three patented synthetic polymers, including R327 for serious bacterial infections, RECCE® 435 for oral bacterial infections, and RECCE® 529 for viral infections. These anti-infectives are designed with multi-layered mechanisms to counteract the rapid mutation rates of bacteria and viruses, a challenge that current antibiotics struggle with.

RECCE® 327 has received the Qualified Infectious Disease Product designation from the FDA under the GAIN Act, which includes a Fast Track Designation and a 10-year market exclusivity post-approval. It is also recognized as the sole synthetic polymer and sepsis drug candidate in development by The Pew Charitable Trusts Global New Antibiotics in Development Pipeline. However, R327 is not yet approved for human use and requires further clinical trials to assess its safety and efficacy fully.

Recce Pharmaceuticals maintains full ownership of its automated manufacturing process, which is instrumental in supporting ongoing clinical trials. The company's mission is to leverage its technological capabilities to address critical medical needs and develop innovative anti-infective treatments.

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