Recce Pharmaceuticals Ltd. announced an Independent Safety Committee has approved the next cohort dosing at a faster infusion rate of 15 minutes of 3,000mg in a Phase I/II clinical trial evaluating its lead anti-infective candidate, RECCE® 327 (R327), which was shown to be safe and well-tolerated in healthy subjects at 1 hour and 30-minute infusion rates of 3,000mg. The next cohort of subjects has been recruited, with dosing to begin imminently. Receiving the committee?s approval to proceed with dosing R327 at a 15-minute infusion rate of 3,000mg is a positive indication of R327?s advancement as a broad-spectrum anti-infective across the full spectrum of urinary tract infections (UTIs), including simple, complicated, and recurring, for its all-out septic state, ?urosepsis.?

If left untreated, UTIs are responsible for about 30% of all sepsis infections, defined as ?urosepsis.?1 This clinical trial aims to showcase R327?s potential as a first patient presentation ?fast-in-fusion? therapy designed to stop any bacterial infection in its tracks. Antibiotics administered as an IV infusion, usually over 30 minutes, have benefits such as savings in nursing time, reduced costs, and improved safety.

In an outpatient setting, IV rapid infusion of antibiotics is useful, as the speed of medication infusion can impact the number of patients treated, patient wait times, and the duration that patients are connected to infusers.2 The 2021 Surviving Sepsis Campaign (SCC) guidelines strongly recommend administering IV broad-spectrum antibiotics as soon as possible, preferably within an hour of sepsis recognition. The Phase I/II trial is evaluating the safety, pharmacokinetics, and pharmacodynamics of R327 following various intravenous doses and infusion rates in healthy subjects. More information on this trial can be found at the Australia New Zealand Clinical Trial Registry (ANZCTR) under the trial ID ACTRN12623000448640.