Recce Pharmaceuticals Ltd (ASX:RCE, OTC:RECEF) has recruited its first cohort in a Phase I intravenous (IV) clinical trial of lead compound RECCE® 327 (R327), the company’s intravenous and topical therapy.
RCE 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® 327 is being developed for the treatment of serious and potentially life-threatening infections including sepsis due to gram-positive and gram-negative bacteria including their superbug forms.
While RECCE® 327 is not yet market approved for use in humans, the current clinical testing required to fully evaluate safety and efficacy, is a step forward in this direction.
Phase 1 trial
The cohort for this Phase 1 trial consists of 10 healthy male subjects.
This Phase I trial is an ascending dose, randomised, placebo-controlled, parallel, double-blind, single-dose study, evaluating the safety and pharmacokinetics of R327 in healthy male subjects (Trial ID ACTRN12621001313820).
In total, 80 healthy male subjects will be enrolled in the trial, which is being conducted at Adelaide's CMAX clinical trial facility.
R327 is administered as a single dose via a 1-hour IV infusion at a uniform rate, with all 80 subjects anticipated to have been dosed by the end of H1 2022.
“Only clinical-stage antibiotic being developed for sepsis”
“We are very pleased to have the first cohort recruited for the clinical trial of R327 (IV),” RCE CEO James Graham said.
“According to the Pew Charitable Trusts, R327 is the only clinical-stage antibiotic in the world being developed for sepsis, representing the largest unmet medical need in human health, the potential medical benefits are very significant indeed.”
The first cohort will be dosed from December 16, 2021, over a two day period with the first set of interim safety subject data expected at the end of 2021.
Further interim datasets on additional cohorts are expected to follow during H1 2022 as more cohorts of subjects are dosed.
More about RECCE® 327
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.
On top of this, 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 wholly owns its automated manufacturing supporting present human clinical trials and its anti-infective pipeline seeks to exploit the unique capabilities of its technologies targeting synergistic, unmet medical needs in human health.
The company has two other patented broad-spectrum synthetic polymer antibiotics: RECCE® 435 for oral administration and RECCE® 529 for viral infections.
Recce anti-infectives comprise of the world’s first multi-layered mechanism of action able to overcome the hypercellular mutation of bacteria and viruses – the challenge of all existing antibiotics to date.
Shares are up 3.7% to A$0.98 while the company's market cap is approximately A$163.36 million.