Viridian announces REVEAL-2 phase 3 study met primary endpoint

Viridian Therapeutics (VRDN) announced positive topline data from the REVEAL-2 phase 3 clinical trial of elegrobart in patients with chronic thyroid eye disease, TED. Elegrobart is a subcutaneously delivered, half-life-extended monoclonal antibody targeting the insulin-like growth factor-1 receptor. REVEAL-2 evaluated two dosing regimens, every four weeks and every eight weeks, compared with placebo. Key Highlights: REVEAL-2 met its primary endpoint with a highly statistically significant treatment effect; Elegrobart Q4W and Q8W achieved 50% and 54% proptosis responder rates at week 24, respectively, versus 15% placebo, both highly statistically significant results; Elegrobart Q4W achieved a statistically significant 61% diplopia responder rate at week 24, versus 38% placebo ; Elegrobart was generally well tolerated in both dose groups, with a safety profile consistent with REVEAL-1 and low rates of hearing impairment; Elegrobart is the only subcutaneous program to demonstrate positive phase 3 data in both active and chronic TED pivotal clinical trials and has the potential to be the first autoinjector treatment for TED; BLA submission on track for Q1 2027