At Scientia Clinical Research, our research team has made incredible progress in evaluating the safety and efficacy of the RECCE® 327 (R327) drug. We completed cohort dosing ahead of schedule and showed that the drug was well-tolerated at two faster IV administration rates, 2,500mg. Furthermore, an independent safety enquiry committee has analyzed the cohort dosing data and now aims to recruit new subjects for the future. We are proud of our achievements and are excited to move forward with our research.
Recce Pharmaceuticals Ltd (ASX: RCE, FSE: R9Q) is thrilled to announce that the dosing of the first cohort in their pivotal Phase l/ll clinical trial of R327 to treat Urinary Tract Infections (UTIs) has been completed at Scientia Clinical Research. The trial involves both male and female subjects, and evaluated the medication at faster infusion rates. Results from the trial will inform the development and understanding of this novel drug, setting the scene for a more effective, safe and reliable battle against the common infection.
Recce Pharmaceuticals’ Chief Executive Officer James Graham has welcomed the news that the study on R327 via two faster infusion rates of 2,500mg across male and female subjects is progressing ahead of schedule. Graham was pleased to find that the dosing has been determined to be safe and well-tolerated. He anticipates that the study will meet all its objectives.
The newly developed drug, GLR327, has been deemed safe and well-tolerated through two quicker infusion rates of 2500mg through IV administration. An independent safety committee examined the data of the entire trial cohort, expressing its approval to move forward. As a result, GLR327 is now ready for its next stage of development.
About Recce Pharmaceuticals Ltd
Recce Pharmaceuticals Ltd (ASX: RCE, FSE: R9Q) is revolutionizing the fight against antibiotic-resistant superbugs and emerging viral pathogens with their New Class of Synthetic Anti-Infectives – setting the path for a healthier, global future.
Recce has developed a revolutionary anti-infective pipeline consisting of three uniquely synthesized polymer compounds. Operating under a broad spectrum, RECCE® 327, 435 and 529 have the potential to overcome the most dreaded challenge that existing antibiotics have failed to conquer: hypercellular mutation of bacteria and viruses. Intravenous and topical RECCE® 327 is ideal for tackling serious and potentially fatal infections due to Gram-positive and Gram-negative bacteria, including their superbug forms.
Meanwhile, orally administered RECCE® 435 can be used to address bacterial infections and RECCE®529 can target viral infections. With their multi-layered mechanisms of action, Recce’s anti-infectives have the potential to revolutionize the way we treat antibiotic-resistant infections.
The FDA has awarded RECCE® 327 a Qualified Infectious Disease Product designation, Fast Track Designation, plus 10 years of market exclusivity post approval. This accolade is highly sought after and puts RECCE® 327 in a league of its own. Moreover, through The Pew Charitable Trusts Global New Antibiotics Development Pipeline, RECCE® 327 is the world’s only synthetic polymer and sepsis drug candidate in development. It has yet to be approved for human use, and clinical testing is required to fully evaluate its safety and efficacy.
Recce’s anti-infective pipeline is pushing the boundaries of technology, aiming to address unmet medical needs with its automated manufacturing capabilities. This manufacturing is currently playing an important role in a number of clinical trials, which are all wholly owned by Recce.