Recce Pharmaceuticals, a company focused on developing synthetic anti-infectives, has recently completed a new phase of clinical trials for its lead drug candidate, RECCE® 327. The trial involved administering the drug to four healthy participants at a dosage of 3,000mg over a period of 20 minutes. The results from this trial are anticipated to provide a foundation for a subsequent Phase II study, which will assess the drug's potential as a primary treatment for urinary tract infections (UTIs) or urosepsis.
James Graham, CEO of Recce Pharmaceuticals, highlighted the significance of this achievement, emphasizing the company's commitment to addressing the global health crisis of antibiotic resistance and improving health outcomes worldwide. An Independent Safety Committee will now assess the data from the trial, and the company is actively recruiting participants for the next phase.
The drug's delivery through rapid intravenous infusion has been recognized as a safe and effective method, which could positively impact patient care, reduce waiting times, and lessen the workload for nursing staff on a global scale. Further details about the trial can be accessed through the Australia New Zealand Clinical Trial Registry with the specific trial ID provided.
Recce Pharmaceuticals is advancing a new class of synthetic anti-infectives to combat antibiotic-resistant bacteria and emerging viral pathogens. Their pipeline includes RECCE® 327, which is being developed for serious infections caused by both Gram-positive and Gram-negative bacteria, including their antibiotic-resistant forms. The company's anti-infectives are designed with multi-layered mechanisms to counteract the rapid mutation rates of bacteria and viruses, a challenge that current antibiotics struggle with.
RECCE® 327 has received a Qualified Infectious Disease Product designation from the FDA under the GAIN Act, which includes a Fast Track Designation and a promise of 10 years of market exclusivity post-approval. The drug has also been recognized by The Pew Charitable Trusts as a unique candidate in the global pipeline for new antibiotics. However, RECCE® 327 is not yet approved for human use and requires further clinical trials to confirm its safety and effectiveness.
The company operates its own automated manufacturing facility, which is instrumental in supporting ongoing clinical trials. Recce's pipeline aims to address medical needs that are currently unmet, leveraging the distinctive features of their technology.
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