OV888/GV101

August 11, 2026: Graviton BioScience said the FDA cleared the IND for a novel capsule formulation of GV101, an oral selective ROCK2 inhibitor, for Friedreich’s ataxia; the company said clearance was received on August 7, 2026 after the 30-day review period. The IND enables a Phase 2 study in FA.

The planned Phase 2 trial is a 12-week, randomized, placebo-controlled, dose-finding study expected to enroll up to 48 participants at U.S. and international sites. The primary endpoint is change from baseline in frataxin levels measured in patients’ cells. An open-label extension is planned for completers, and participants may remain on existing FDA-approved standard-of-care therapy. Enrollment is expected to begin in Q1 2027.

Graviton said the capsule formulation showed improved pharmacokinetics and oral bioavailability in healthy volunteers in Phase 1. The company also reported favorable safety/tolerability in preclinical and clinical studies, with more than 500 participants exposed to GV101 for up to 24 weeks and extension studies beyond one year. It said preclinical and clinical studies showed increased frataxin mRNA and protein levels, including in patient-derived cells and PBMCs from an obesity study.