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Recce Pharmaceuticals (ASX:RCE) selects CMAX for phase I/II UTI clinical trial

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ASX:RCE      MCAP $108.9M
20 February 2023 12:20 (AEDT)

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Recce Pharmaceuticals (RCE) has selected CMAX Clinical Research in South Australia as the independent facility for a clinical trial to treat urinary tract infections (UTIs).

The phase one and two intravenous clinical trial will assess the company’s lead drug candidate, RECCE 327 (R327), in approximately 12 healthy male and female subjects.

Plasma and urine will be collected at various time points during and following dosing to evaluate R327’s concentrations and antibacterial effect in the urine on various bacterial strains.

The trial follows an independent in-vitro study that found R327 in the presence of human urine was able to have a fast effect against E. coli bacteria, which is responsible for around 90 per cent of UTIs.

Initial dosing is scheduled for this quarter and will evaluate the drug as an intravenous dose at faster infusion rates across three cohorts.

In selecting the facility, Recce Pharmaceuticals CEO James Graham said the company was “thrilled” to be building upon the successes of a recent phase one study with the team at CMAX.

The study demonstrated R327 could be administered safely and achieve concentrations in the urine that were 20-fold those achieved in plasma.

Principal Investigator Nicholas Farinola said a high concentration of R327 in the human bladder suggested R327 may be used as a broader anti-infective treatment in urosepsis.

UTIs are responsible for about 30 per cent of all sepsis infections and Recce said there were currently no drug therapies approved for treatment.

Recce shares were trading at 58 cents at midday AEDT.

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