Cyclarity Therapeutics Launches Phase 1 Trial for Heart Disease Drug UDP-003 in Australia
January 13, 2025
Dr. Matthew O’Connor, CEO of Scientific Affairs at Cyclarity, explained that delays in starting the trials were due to a backlog at the MHRA following Brexit.
Originally, the clinical trials were planned for Cambridge, UK, but the decision to relocate to Australia was made to streamline the process.
All required documentation for trial authorization has been submitted and approved, with the trial expected to begin shortly.
UDP-003 is designed to target 7-ketocholesterol, a detrimental oxidized cholesterol variant linked to atherosclerosis and heart disease, which is the leading cause of death worldwide.
The manufacturing process for UDP-003 has been completed in accordance with Current Good Manufacturing Practice (CGMP), ensuring the drug's quality and safety for human use.
This Phase 1 clinical study will evaluate the safety and preliminary efficacy of UDP-003, which includes a segment involving 12 patients with acute coronary syndrome.
If proven successful, UDP-003 could potentially reverse heart disease in 70-80% of patients, marking a significant improvement over existing treatments such as lifestyle changes and statins.
This trial represents a crucial milestone for Cyclarity, emphasizing the potential to tackle age-related diseases by addressing their root causes.
Cyclarity Therapeutics, a biotechnology firm located at the Buck Institute in California, has launched its inaugural human clinical trial for the candidate drug UDP-003.
The trials are set to take place at CMAX in Australia, in partnership with Monash University and overseen by Dr. Stephen Nicholls, a well-respected cardiologist.
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Lifespan Extension Advocacy Foundation • Jan 13, 2025
Cyclarity Launches Human Trial for Atherosclerosis