Cohort dosing complete in healthy subjects, with the Phase I/II study on track to meet primary endpoints
RECCE® 327 was found to be safe and well-tolerated at a faster infusion rate of 30 minutes of 3,000mg via intravenous administration
Independent Safety Committee to review cohort data, with the subject recruitment for next underway
SYDNEY, Australia, Sept. 26, 2023 (GLOBE NEWSWIRE) -- Recce Pharmaceuticals Ltd (ASX: RCE, FSE: R9Q) (the Company), the Company developing a new class of synthetic anti-infectives, today announced it completed cohort dosing of healthy male and female subjects in its Phase I/II clinical trial evaluating its lead anti-infective candidate, RECCE® 327 (R327), at faster infusion rates. R327 is being developed as a potential treatment for urinary tract infections (UTIs), which, if left untreated, may lead to sepsis, defined as ‘urosepsis.’
R327 was shown to be safe and well-tolerated at a faster infusion rate of 30 minutes of 3,000mg, with an Independent Safety Committee reviewing the complete cohort data, expected to recommend go ahead, with recruitment well underway.
“We are pleased to see R327 administered at a faster infusion rate of 3,000mg, reinforcing R327’s safety profile among male and female subjects,” said James Graham, Chief Executive Officer of Recce Pharmaceuticals. “These results further support R327’s potential as a treatment option for patients with UTIs, which, if left untreated, could result in urosepsis. Today, urosepsis accounts for approximately 30% of all sepsis infections and significantly impacts both patients and the healthcare industry.”
The Phase I/II trial is evaluating the safety, pharmacokinetics, and pharmacodynamics of R327 following various intravenous doses and infusion rates in healthy subjects. More information on this trial can be found at the Australia New Zealand Clinical Trial Registry (ANZCTR) under the trial ID ACTRN12623000448640.
About Recce Pharmaceuticals Ltd
Recce Pharmaceuticals Ltd (ASX: RCE, FSE: R9Q) 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: RECCE® 327 as 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 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.
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.
Recce wholly owns its automated manufacturing, which is supporting present clinical trials. Recce’s anti-infective pipeline seeks to exploit the unique capabilities of its technologies targeting synergistic, unmet medical needs.
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