Urinary Tract Infection IV Infusion Candidate Increases Dosage

Recce Pharmaceuticals Ltd. 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 clinical trial evaluating its lead candidate, RECCE® 327 (R327).

The Company says it identified 30 minutes as the optimum infusion time and increased to a higher concentration per regulatory expectations to investigate R327’s high concentration potential.

“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, in a press release on April 30, 2024.

“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 (UTI) or urosepsis each year.”

Dosing has successfully achieved Minimum Inhibitory Concentration activity among existing clinical samples. The Company has now dosed 3,000mg at multiple infusion times: 15, 20, 30, 45 minutes, and 1 hour.

In accordance with the study protocol, the efficacy of R327 via IV administration will be made available at the completion of the ACTRN12623000448640 trial.

Recce’s New Class of Synthetic Anti-Infectives have a universal mechanism of action with the ability to overcome hyper-cellular mutation of bacteria and viruses. RECCE® 327 is not a preventive vaccine and is not approved for use in humans in any country.

The investigational recurrent UTI vaccine MV140 is available in Australia and various countries in 2024.