other material
confidence high
sentiment positive
materiality 0.65
Inhibikase enrolls first patient in Phase 3 PAH study of IKT-001
Inhibikase Therapeutics, Inc.
- First patient enrolled in global pivotal Phase 3 IMPROVE-PAH trial (NCT07365332).
- Part A: ~140 patients, primary endpoint change in PVR at Week 24, double-blind placebo-controlled.
- Part B: ~346 patients, primary endpoint change in 6MWD at Week 24, seamless transition from Part A.
- Adaptive design includes a 12-week dose-titration phase; FDA confirmed study plan.
- Trial to be conducted at up to ~180 sites worldwide; NDA filing timeline accelerated.