Cyclarity presented Phase 1 clinical data for its lead candidate UDP-003 at the American Heart Association Vascular Discovery Scientific Sessions, reporting the first clinical demonstration that 7-ketocholesterol (7KC) can be mobilized and excreted in humans, according to the company.
The trial was a first-in-human, randomized, double-blind, placebo-controlled study conducted at Monash Victorian Heart Institute with single and multiple dosing across six dose levels; the company reports that primary, secondary and exploratory endpoints for safety, pharmacokinetics and pharmacodynamics were met and exceeded.
Key findings included dose-dependent urinary excretion of 7KC, no serious adverse events across dose-escalation cohorts, a short half-life of approximately three hours with no meaningful bioaccumulation, and a linear dose-exposure pharmacokinetic profile that could support infrequent dosing.
Cyclarity describes UDP-003 as an engineered cyclodextrin that binds selectively to 7KC to render it soluble for renal elimination; the candidate is the first clinical-stage asset discovered using the company’s AI drug discovery platform.
The company is enrolling an acute coronary syndrome efficacy cohort with pre- and post-treatment coronary CT angiography and expects to initiate a Phase 2 trial later in 2026 designed to demonstrate plaque regression as a primary endpoint.
