Inhibikase Therapeutics announced enrollment of the first patient in its pivotal Phase 3 IMPROVE-PAH study for IKT-001 in pulmonary arterial hypertension, marking a major milestone toward potential NDA filing.
Key takeaways
First patient enrolled in global Phase 3 IMPROVE-PAH study (NCT07365332) for IKT-001 in PAH, a major milestone for the company.
Study is two-part adaptive design: Part A (140 patients) measures pulmonary vascular resistance; Part B (346 patients) measures 6-minute walk distance.
IKT-001 is an oral prodrug of imatinib designed to reduce gastrointestinal side effects, with over two decades of imatinib clinical experience.
Study includes 12-week dose-titration phase and permits sample size re-estimation for Part B based on Part A findings.
Trial expected to be conducted at up to approximately 180 sites worldwide, with uninterrupted enrollment between study parts.