Rece Pharmaceuticals Ltd. (ASX: RCE, FSE: R9Q) is excited to announce that their clinical trial for a new category of synthetic anti-infectives to be used in urinary tract infections (UTIs) has kicked off with its first subject dosing.
The Phase I/II study, conducted by Scientia Clinical Research, is looking at alternative infusion rates for the drug R327. This promising pharmacological development hopes to expand the access to effective treatments for the growing UTI problem.
The Company is making great strides towards patient recruitment and broadening its patient population by expanding its clinical trial sites to include Scientia Clinical Research in Sydney, New South Wales. This superb progression has enabled the subject to receive infusions of R327 at a significantly quicker rate of 2,500mg through IV administration, setting a new standard for speed and accuracy.
This week marks a major milestone for Scientia Clinical Research, with the final remaining subjects receiving their dose of the experimental treatment. The encouraging results of this study have set it on track to meet its primary endpoints, with data read-outs expected in 2H 2023.
About Recce Pharmaceuticals Ltd
Rece Pharmaceuticals Ltd (ASX: RCE, FSE: R9Q) is revolutionizing the way we combat antibiotic-resistant superbugs and emerging viral pathogens with their innovative New Class of Synthetic Anti-Infectives. This cutting-edge solution has the potential to transform the global healthcare landscape and improve the lives of millions of people.
Recce’s anti-infective pipeline encompasses three cutting-edge, patented polymeric anti-infectives: RECCE® 327 as an intravenous and topical therapy for combating serious and potentially life-threatening bacterial infections, Gram-positive and Gram-negative alike. RECCE® 435 is an orally administered treatment for bacterial infections, while RECCE®529 targets viral infections directly.
By attacking these pathogens at multiple angles, Recce’s biopolymer anti-infectives may overcome the challenge of hypercellular mutation of bacteria and viruses – a barrier that many existing antibiotics have failed to surmount.
The U.S. Food and Drug Administration has awarded RECCE® 327 with Qualified Infectious Disease Product designation, including Fast Track Designation and 10 years of market exclusivity after approval.
This milestone has earned RECCE® 327 a spot on The Pew Charitable Trusts’ Global New Antibiotics in Development Pipeline, making it the only synthetic polymer and sepsis drug candidate in the world. Though it is not yet approved for human use, further clinical testing is currently being conducted to assess safety and effectiveness.
Recce has taken the initiative in the clinical trials arena with its wholly-owned automated manufacturing capabilities. Streamlined operations have allowed Recce to develop its anti-infective pipeline, which is tailored to target unmet medical needs in an efficient and synergistic way.