Viridian Therapeutics announces long-term durability data from THRIVE trial

Viridian Therapeutics (VRDN) announced long-term durability data from the THRIVE phase 3 clinical trial of veligrotug, an intravenously delivered anti-insulin-like growth factor-1 receptor antibody, in patients with active thyroid eye disease. TED is an autoimmune condition characterized by inflammation, growth, and damage to tissues around and behind the eye. The THRIVE phase 3 clinical trial in active TED evaluated 5 infusions of veli or placebo every three weeks with primary topline analysis at week 15 and then followed patients through week 52. 70% of veligrotug patients in THRIVE, who were proptosis responders at week 15 and continued follow-up to the end of the study at week 52, maintained their proptosis response. Maintenance of response is defined as responders at week 15 who still had at least a 2-millimeter reduction in proptosis compared to baseline at week 52, without worsening in the fellow eye, as measured by exophthalmometry. There were no changes to the safety profile in the follow-up period. The vast majority of adverse events reported at the week 15 primary analysis had resolved by week 52. As announced in late 2024, veligrotug met all of its primary and secondary endpoints and was generally well-tolerated in its pivotal phase 3 clinical trials, THRIVE and THRIVE-2, for active and chronic TED, respectively. Veligrotug demonstrated a rapid onset of treatment effect and statistically significant and clinically meaningful reduction and resolution of diplopia in both clinical trials. THRIVE-2 was the first data set from a global phase 3 clinical trial in chronic TED patients to demonstrate statistically significant diplopia response and resolution. Together, THRIVE and THRIVE-2 comprise the largest pivotal program to date in TED.