Recce Pharmaceuticals Ltd (ASX:RCE, OTC:RECEF) has reported that an Independent Safety Committee data review of 10 healthy human subjects dosed in the Phase I intravenous (IV) clinical trial of RECCE® 327 (R327), demonstrated good safety and tolerability at 1,000mg.
RCE is developing a New Class of Synthetic Anti-Infectives designed to address the urgent global health problems of antibiotic-resistant superbugs and emerging viral pathogens.
36 human subjects were successfully dosed in the Phase I trial of R327 and with the Low-dose’ cohorts data review complete and end points achieved, the path was paved for the Independent Safety Committee to recommend ‘high dose’ Cohort 5 (R327, 2,000mg IV) dosing to begin.
Recce is wasting no time, with subjects already recruited and dosing underway.
James Graham, Chief Executive Officer of Recce Pharmaceuticals Ltd said, “Recommendation to commence ‘high dosing’ at 2,000mg – a 40-fold increase from initial dosing of 50mg in Cohort 1 by the independent safety committee is a welcome validation with first human subject dosing now underway.”
The news comes just a day after the company was granted an antiviral Patent Family 3 titled “Anti-Virus Agent and Method for Treatment of Viral Infection” by the Hong Kong special administrative region, furthering marketing, and manufacturing monopolies for its RECCE® suite of anti-infectives until February 2037.
Read: Recce Pharmaceuticals granted anti-viral patent in Hong Kong for RECCE Anti-Infectives
About Phase 1
The Phase I trial is an ascending dose, randomised, placebo-controlled, parallel, double-blind, single-dose study being conducted at Adelaide's CMAX clinical trial facility.
The study is evaluating the safety and pharmacokinetics of R327 in 7-10 healthy subjects per dose, across eight sequential dosing cohorts of 50-16,000mg (Trial ID ACTRN12621001313820) and is on track to have all Phase I dosing complete by Q2 2022.
According to PEW Charitable Trusts Global Antibiotic pipeline review, R327 is the only clinical stage new class of antibiotic in the world being developed for sepsis, the largest unmet medical need in human health.