Viridian Therapeutics, Inc. announced positive top-line 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 (IGF‑1R). REVEAL‑2 evaluated 2 dosing regimens, every 4 weeks (Q4W) and every 8 weeks (Q8W), compared with placebo, the company said in a press release.
REVEAL‑2 assessed the efficacy and safety of subcutaneous Q4W or Q8W elegrobart vs placebo in patients with chronic TED. The clinical trial enrolled 204 patients, randomized 1:1:1 to elegrobart Q4W (n=70), elegrobart Q8W (n=68), and placebo (n=66). According to the company, REVEAL-2 met its primary endpoint for both the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) with high statistical significance (P<.0001). In addition, REVEAL-2 met all its proptosis key secondary endpoints in the Q4W and Q8W treatment arms with high statistical significance, and the Q4W treatment arm showed a statistically significant diplopia responder rate at week 24. Efficacy was generally consistent regardless of baseline clinical activity score (CAS). Results from primary and all key secondary endpoints at week 24 are presented below:
Results with P<.025 are statistically significant.
1Participants with both proptosis and clinical activity score (CAS) response; CAS response defined as no worsening in CAS from baseline in study eye, without deterioration in fellow eye (≥2-point increase).
Elegrobart was generally well tolerated in REVEAL‑2 with a safety profile consisting of adverse events generally expected from the anti-IGF-1R class, the vast majority of which were mild. Rates of hearing impairment were low in both the Q4W and Q8W treatment arms (4.1% and 8.8% placebo-adjusted rates, respectively). Ninety-one percent of elegrobart-treated patients completed the full course of treatment, and there were no treatment-related serious adverse events, the company said in the press release.
REVEAL‑2 is the second successful pivotal phase 3 clinical trial for elegrobart, following positive results from REVEAL‑1 in active TED. Viridian said it remains on track to submit a Biologics License Application (BLA) to the FDA for elegrobart in Q1 2027. If approved, elegrobart has the potential to offer a convenient, at‑home treatment in as few as 3 doses for both active and chronic patients, the company said in the press release.
Viridian said it is prepared for the planned US commercial launch for veligrotug, its lead program for TED, and anticipates the veligrotug commercial and medical affairs infrastructure will support a potential elegrobart launch, if approved, with limited incremental investment. Veligrotug was granted Breakthrough Therapy Designation from the FDA, and its BLA is under Priority Review at the FDA with a Prescription Drug User Fee Act (PDUFA) target action date of June 30, 2026.