Coiled Therapeutics completes Phase I trial enrollment for AO-252 lipid formulation

Coiled Therapeutics plc has completed enrollment in the Phase I trial of AO-252, an experimental small-molecule inhibitor targeting genetically defined cancers, by dosing two cohorts of patients with a lipid-based softgel formulation. The study, identified as protocol NCT06136884, includes 3 patients in a 120mg twice-daily cohort and 3 in a 160mg once-daily cohort, marking the first administration of the new formulation on August 3, 2026. The company expects to dose up to 30 patients by the end of 2026, with initial safety and pharmacokinetic data anticipated for late-year readouts. The trial follows a previous tablet formulation, which demonstrated an 80% clinical benefit rate in twice-daily dosing and 40% in once-daily dosing across 10 patients, but the new lipid-based softgel aims to address absorption variability and enhance bioavailability. The dose-expansion cohorts will focus on ovarian and prostate cancers.