Cyclarity Therapeutics has received regulatory approval to commence its first-in-human clinical trial for UDP-003 at CMAX in Australia, partnered with Monash University and led by renowned cardiologist Dr. Stephen Nicholls. The trial will include a standard Phase 1 study and an exploratory component involving 12 Acute Coronary Syndrome (ACS) patients to evaluate both safety and potential efficacy in individuals with plaque buildup. This trial signifies a crucial step towards addressing the substantial unmet need in cardiovascular disease treatment.
This clinical trial initiation is a notable advancement in cardiovascular research, particularly given Dr. Nicholls’ involvement and his history of leading impactful cardiovascular trials, including studies on Crestor, bempedoic acid, and Lp(a). The inclusion of ACS patients in this early phase demonstrates Cyclarity’s proactive approach to assessing the therapy’s potential impact in a critical patient population. This provides valuable early insights into the drug’s efficacy and allows the company to gather preliminary data on its disease-modifying potential, significantly accelerating the development timeline.
The trial’s initiation is underpinned by several key achievements: the successful manufacture and preparation of UDP-003 clinical trial material, the completion of all necessary Investigational New Drug (IND) enabling studies with no significant safety concerns identified, and the successful submission of all required documentation for clinical trial authorization.
This first-in-human trial marks a pivotal transition for Cyclarity into a clinical-stage company. The results of this study will be highly anticipated, as they hold the potential to validate UDP-003’s mechanism of action and pave the way for larger-scale clinical trials to rigorously assess its efficacy in treating cardiovascular disease. The combination of a robust pre-clinical data package and the expertise of Dr. Nicholls positions Cyclarity to potentially reshape the landscape of cardiovascular therapeutics.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
