Recce Pharmaceuticals Ltd (ASX:RCE, OTC:RECEF) has received positive data from the fourth cohort of its Phase 1 intravenous clinical trial of RECCE® 327 (R327) at 1,000mg – a 20-fold increase on the first cohort, which was given a 50mg dose – that indicates good safety and tolerability profile among 10 healthy male subjects.
CEO of the company, James Graham, said: “Achieving a dosing level of 1,000mg is another significant milestone for the company.
“Indicating R327 to be safe and well-tolerated at a 20-fold increase of the initial dosing level of 50mg is pleasing, not only for the unmet medical need of sepsis, but so too for synergies across our wider infectious disease portfolio.”
Demonstrated safety and tolerability
R327 was indicated to be safe and well tolerated at 1,000mg, with no clinically significant changes in vital signs or adverse events associated with R327.
The Phase 1 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 evaluates the safety and pharmacokinetics of R327 in seven to 10 healthy subjects per dose, across eight sequential dosing cohorts of 50 to 16,000mg. The study is on track to complete all Phase 1 dosing by the second quarter of the year.
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, according to PEW Charitable Trusts global antibiotic pipeline review.
An independent safety committee is set to review the data from this fourth cohort and Recce expects that the recommendation will be to proceed. In anticipation of this outcome, the fifth cohort is underway in Sydney, with results to follow.
About Recce Pharmaceuticals
Recce Pharmaceuticals is developing new classes 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:
- RECCE® 327, 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;
- RECCE® 435, 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.
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.