Prime Medicine Gets FDA IND Clearance for PM577a; Global Phase 1/2

Prime Medicine announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for PM577a, an investigational in vivo Prime Editor for Wilson disease. This clearance, combined with a previously cleared New Zealand Clinical Trial Application (CTA), establishes a global Phase 1/2 clinical program. PM577a targets the H1069Q mutation in the ATP7B gene, which is the most prevalent WD-causing allele in North America and Europe. The company expects to initiate the Phase 1/2 trial in the second half of 2026, with initial clinical data anticipated in 2027.