Cyclarity Therapeutics has initiated a Phase 1 human clinical trial for UDP-003, a drug aimed at eliminating arterial plaques, which are a major contributor to heart attacks and strokes.

Dr. Matthew O’Connor, CEO of Scientific Affairs at Cyclarity, highlighted the personal significance of this milestone after years of dedicated development.

The trial is being overseen by Dr. Stephen Nicholls, a well-respected cardiologist with extensive experience from the Cleveland Clinic and involvement in significant cardiovascular drug trials.

Conducted at CMAX in Australia in collaboration with Monash University, participant enrollment for the trial opened on January 22, 2025.

The trial will evaluate both single and multiple doses of UDP-003 to assess its safety and efficacy, with an additional $2.6 million needed for subsequent phases.

Cyclarity has successfully raised approximately $6.4 million in funding to support the initial safety phase of the trial, which will involve 72 healthy volunteers.

In addition to its focus on atherosclerosis, Cyclarity is investigating the potential of UDP-003 for treating brain aging and Alzheimer’s disease, given the implications of oxidized cholesterol.

Dr. O’Connor articulated a vision centered on saving lives rather than pursuing financial gain, aiming to make a significant impact on humanity.

UDP-003 operates by promoting macrophages, a type of immune cell, to consume arterial plaque instead of transforming into foam cells that contribute to plaque accumulation.

The drug specifically targets 7-ketocholesterol, an oxidized form of cholesterol that plays a role in the development of atherosclerosis as individuals age.

While Cyclarity anticipates interest from pharmaceutical companies, the company aims to first demonstrate positive results from the Phase 1 trial.

The Australian healthcare system provides a more flexible and iterative approach to clinical trial applications compared to the more rigid processes found in the US and UK.