Recce Pharmaceuticals has finished dosing the first cohort of patients in a Phase I/II urinary tract infection (UTI) clinical trial evaluating R327 at faster infusion rates.

The study of R327 for UTI (ACTRN12623000448640) will see four cohorts, each comprising four patients, administered different doses. The first cohort will receive a single dose of R327, 2500mg at a dose concentration of 8mg/ml, intravenously (IV) for 45 minutes, followed by 48 hours of safety surveillance and pharmacokinetic data collection.

All participants will receive a second dose of R327, 2,500mg at the same dose concentration by IV for 30 minutes and with a minimum time elapsed of 48 hours from the start of the first dose to the second dose. Cohorts two to four will be dosed twice like the first cohort but the dose will range from 2,000mg to 3,000mg, infusion duration will range between 15 minutes to 45 minutes, and R327 concentration will range from 4mg/ml to 8mg/ml.

Preliminary data

R327 was safe and well-tolerated at two faster infusion rates of 2,500mg via IV administration. An independent safety committee has reviewed the complete cohort dosing data and is expected to recommend continuing the study.

Recce Pharmaceuticals CEO James Graham said: “R327 via two faster infusion rates of 2,500mg across male and female subjects continues to be shown as safe and well-tolerated. Completing dosing well ahead of schedule is a welcomed confirmation that we are on track to achieve the study’s objectives.”

What is R327?

Recce Pharmaceuticals is developing a new class of synthetic anti-infectives such as R327 to address the urgent global health problems of antibiotic-resistant superbugs and emerging viral pathogens.

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R327 is an intravenous and topical therapy in development to treat serious and potentially life-threatening infections caused by gram-positive and gram-negative bacteria.

It is also being trialled in a number of indications, including Escherichia-coli Infections, Methicillin-Resistant Staphylococcus aureus (MRSA) Infections, Staphylococcus aureus Infections, Bacterial Sepsis, and Influenza A Virus.

The US Food and Drug Administration (FDA) awarded R327 Qualified Infectious Disease Product designation under the Generating Antibiotic Initiatives Now (GAIN) Act. It was also labelled for fast-track designation and given ten years of market exclusivity post-approval.

R327 has also 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.