Key points from article :
Cyclarity Therapeutics has received regulatory approval to initiate its first-in-human clinical trial at CMAX, one of Australia’s top clinical research facilities, in collaboration with Monash University. Led by Dr. Stephen Nicholls of the Victorian Heart Institute, a renowned expert in cardiovascular medicine, the trial will include a traditional single-ascending dose (SAD) and multiple-ascending dose (MAD) phase. It will also assess the safety of Cyclarity’s drug, UDP-003, in 12 patients with Acute Coronary Syndrome (ACS) to explore its potential impact on plaque buildup, addressing a critical unmet medical need.
The trial's readiness underscores Cyclarity’s meticulous preparation, with clinical trial materials manufactured and validated, investigational new drug (IND)-enabling studies completed without toxicological concerns, and all regulatory submissions finalized. This marks a pivotal step for the company, transitioning it into a clinical-stage biotech with a focus on disease-modifying therapies for cardiovascular conditions.
Dr. Nicholls, known for landmark studies like the SATURN trial for Crestor and recent innovations targeting Lp(a), brings a legacy of groundbreaking research to the project. Cyclarity’s CEO of Scientific Affairs, Matthew O’Connor, emphasized the significance of this milestone in tackling cardiovascular disease, the world’s leading cause of death. The company invites continued engagement as it advances its mission to transform cardiovascular care.
