Recce Pharmaceuticals Ltd (ASX:RCE, OTC:RECEF) has received Human Research Ethics Committee (HREC) approval to expand its Faster Infusion, Phase I/II Urinary Tract Infections (UTI) intravenous clinical trial of lead product RECCE® 327 (R327).
The HREC approval will see study dosing at CMAX Clinical Research in South Australia expanded to include Scientia Clinical Research in New South Wales.
Further dosing in Sydney
It allows for further dosing at Scientia Clinical Research in Sydney, thus broadening patient population across multiple world-class facilities.
The clinical trial being conducted by RCE, which is developing a new class of synthetic anti-infectives, is assessing R327 at faster administration rates, potentially applicable for use at first patient presentation within a GP or Acute patient setting.
“To expedite trial progress”
Recce Pharma’s chief executive officer James Graham said: “We are pleased to expand our Phase I/II UTI studies with Scientia Clinical Research (NSW) joining present dosing at CMAX (SA).
"This now multi-state study expects to expedite our clinical trial progress and address the global health threats posed by UTIs and Urosepsis.”
R327 will be administered in approximately 16 participants as a broad-spectrum anti-infective across the full spectrum of UTIs (simple, complicated & recurring), with a Phase II in UTI patients expected to be initiated in the second half of this year.
About Scientia Clinical Research
Scientia Clinical Research is an FDA-audited world-class clinical trials facility in Sydney, NSW, specialising in first-in-human and first-in-patient studies, as well as single and multiple dose studies, food effect studies, drug interaction studies, ethnopharmacology, formulation studies.
It is co-located in a major research precinct with Prince of Wales Hospital, Royal Hospital for Women, UNSW and the Lowy Cancer Research Centre.
About Recce Pharmaceuticals
Recce Pharmaceuticals' anti-infectives are designed to address the urgent global health problems of antibiotic-resistant superbugs and emerging viral pathogens.
The company’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 lifethreatening 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 R327 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, R327 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.