Recce Pharmaceuticals Ltd (ASX:RCE, OTC:RECEF) has received a unanimous recommendation from an independent safety committee to proceed to cohort four of a Phase I intravenous (IV) clinical trial of RECCE® 327 - the only clinical-stage new class of antibiotic in the world being developed for sepsis.
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.
Looking ahead, the study is on track to have all Phase I dosing complete by the June quarter of 2022 with cohort four subjects already recruited and R327 1,000mg IV dosing starting today.
“Wonderful endorsement”
Recce CEO James Graham said: “Recommendation to start IV dosing of Cohort 4 (R327 IV; 1,000mg) is a wonderful endorsement for the compelling Safety and Tolerability profile demonstrated among 10 subjects of Cohort 3.
“With subjects in Cohort 4 recruited and dosing starting today, we are on track to complete Cohort 4 this week.”
Phase I trial
The Phase I trial is an ascending dose, a randomised, placebo-controlled, parallel, double-blind, single-dose study being conducted at Adelaide's CMAX clinical trial facility.
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® 327
RECCE® 327 is an intravenous and topical therapy that is being developed for the treatment of serious and potentially life-threatening infections due to Gram-positive and Gram-negative bacteria including their superbug forms.
The FDA has awarded RECCE® 327 Qualified Infectious Disease Product designation under the Generating Antibiotic Initiatives Now (GAIN) Act – labelling it for Fast Track Designation, plus 10 years of market exclusivity post-approval.
Further to this designation, RECCE® 327 has 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.
RECCE® 327 is not yet market approved for use in humans with further clinical testing required to fully evaluate safety and efficacy.
About Recce
Recce 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.
Recce’s anti-infective pipeline includes three patented, broad-spectrum, synthetic polymer anti-infectives including RECCE® 327, RECCE® 435 as an orally administered therapy for bacterial infections; and RECCE® 529 for viral infections.
Through their multi-layered mechanisms of action, Recce’s anti-infectives have the potential to overcome the hypercellular mutation of bacteria and viruses – the challenge of all existing antibiotics to date.