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Viridian Therapeutics submits BLA for veligrotug by end of 2025?
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Viridian Therapeutics' Veligrotug Shows Strong Efficacy in Phase 3 Trial for Thyroid Eye Disease
Dec 16, 2024, 12:26 PM
Viridian Therapeutics Inc. announced positive topline results from its Phase 3 THRIVE-2 clinical trial evaluating veligrotug, an intravenously administered anti-IGF-1R antibody, for the treatment of chronic thyroid eye disease (TED). The trial met all primary and secondary endpoints, showing statistically significant improvements in proptosis, diplopia, and Clinical Activity Scores (CAS) after only five infusions. The study involved 188 patients, with veligrotug demonstrating a 56% proptosis responder rate (PRR) compared to 8% for placebo, and a 56% diplopia response rate against 25% for placebo. The drug was generally well-tolerated, with a 9.6% placebo-adjusted rate of hearing impairment. Viridian is preparing for a Biologics License Application (BLA) submission in the second half of 2025, aiming to offer a differentiated product profile for TED patients. Additionally, the company is advancing its subcutaneous VRDN-003 program, with topline data expected in the first half of 2026.
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