Cyclarity Therapeutics has announced the commencement of its first-in-human clinical trial for UDP-003, a novel therapeutic aimed at addressing atherosclerosis by removing arterial plaques. The Phase 1 trial, conducted at CMAX in Australia in partnership with Monash University and led by Dr. Stephen Nicholls, marks a significant step forward in the fight against cardiovascular disease, the leading cause of death worldwide.
Targeting Oxidized Cholesterol
UDP-003, Cyclarity's primary drug candidate, targets 7-ketocholesterol, a form of oxidized cholesterol that accumulates in cells and tissues with age and is a key component of arterial plaques. The drug is designed to stimulate the body's own immune cells, specifically macrophages, to engulf and remove plaque buildup. According to Dr. Matthew O'Connor, CEO of Scientific Affairs at Cyclarity, UDP-003 aims to "turn the foam cell back into a healthy macrophage and allows it to go back to doing its job," facilitating plaque shrinkage and arterial healing.
Trial Design and Endpoints
The Phase 1 trial includes a traditional single ascending dose (SAD) and multiple ascending dose (MAD) study in healthy volunteers. It also incorporates a unique segment involving 12 patients with acute coronary syndrome (ACS) to assess the safety of UDP-003 in individuals with existing plaque buildup and to gather preliminary evidence of efficacy. The trial's primary focus is on assessing the safety and tolerability of UDP-003, with secondary endpoints exploring potential effects on plaque volume and composition.
Addressing Unmet Needs in Cardiovascular Care
Despite existing treatments like statins, which slow down plaque accumulation, there remains a significant unmet need for therapies that can reverse atherosclerosis. Dr. Nicholls, a distinguished leader in cardiovascular medicine, noted that current lipid-lowering drugs only slow down the accumulation of plaque, while UDP-003 has the potential to reverse plaque buildup. Cyclarity hopes UDP-003 will offer a disease-modifying approach to cardiovascular care.
Future Directions
Cyclarity Therapeutics is also exploring the potential of UDP-003 in other age-related diseases, including Alzheimer's disease and non-alcoholic fatty liver disease, where oxidized cholesterol accumulation may play a role. The company is also investigating the use of its technology to address the accumulation of other toxic substances, such as nanoplastics, in biological systems and the environment.
