Recce Pharmaceuticals Ltd (ASX:RCE, OTC:RECEF) has successfully completed the third cohort of testing for a Phase 1 clinical trial assessing the safety and tolerability of intravenously administered RECCE® 327 (R327) in healthy subjects.
The last three subjects were dosed with 500mg of intravenous (IV) R327, with results indicating a good safety and tolerability profile in 10 healthy male subjects.
Recce’s synthetic anti-infective targeting sepsis was indicated to be safe and well tolerated at 500mg with no clinically significant changes in vital signs or adverse events associated with R327.
“Compelling safety profile at a milestone dose”
Reece Pharmaceutical chief executive officer James Graham said: “Completing this cohort with the maximum number of subjects, sees R327 (500mg, I.V.) further a compelling safety profile at a milestone dose.
“We anticipate recommendation to start dosing Cohort 4 at higher concentrations again in near weeks.”
This Phase 1 trial is an ascending dose, randomized, 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 (absorption, distribution, metabolism, and excretion) of R327 in 7-10 healthy subjects per dose, across eight sequential dosing cohorts of 50-16,000mg (Trial ID ACTRN12621001313820).
The study is on track to have all Phase I dosing complete by the second quarter of 2022.
According to PEW Charitable Trusts global antibiotic pipeline review, R327 is the only clinical-stage new class of antibiotics in the world being developed for sepsis, the largest unmet medical need in human health.
About Recce Pharmaceuticals
Recce Pharmaceuticals is pioneering a new class of synthetic anti-infectives to address the urgent global health threat posed by superbugs and emerging viral pathogens.
Recce’s anti-infectives have been designed with a unique mechanism of action, with the goal of re-empowering physicians with an effective treatment that may be used repeatedly against a broad range of bacteria and viruses. They include:
➢ RECCE® 327 is a fast-acting, broad-spectrum antibiotic effective against Gram-positive and Gram-negative bacteria, including antibiotic-resistant superbugs;
➢ RECCE® 435 is a broad-spectrum synthetic polymer antibiotic formulated for oral use;
➢ RECCE® 529 is a synthetic polymer anti-infective focused on viral indications following Recce’s background antiviral research.
The US Food and Drug Administration (FDA) awarded RECCE® 327 a Qualified Infectious Disease Product (QIDP) designation under the Generating Antibiotic Initiatives Now (GAIN) Act - labelling RECCE® 327 for fast track designation, plus 10 years of market exclusivity post approval.