Viridian Therapeutics, Inc. has announced positive topline results from its Phase 3 REVEAL-1 clinical trial evaluating elegrobart (VRDN-001) for the treatment of active Thyroid Eye Disease (TED). The trial met its primary endpoint and all secondary endpoints, showing statistically significant and clinically meaningful improvements compared to placebo.
Thyroid Eye Disease is a serious, progressive, and vision-threatening autoimmune disease. The REVEAL-1 trial assessed the efficacy and safety of elegrobart, an investigational subcutaneous monoclonal antibody designed to inhibit the insulin-like growth factor-1 receptor (IGF-1R).
According to the company's press release, the results support the potential of elegrobart as a new treatment option. Viridian plans to engage with regulatory authorities and is preparing for a potential Biologics License Application (BLA) submission to the U.S. Food and Drug Administration.
The safety profile observed in REVEAL-1 was reportedly consistent with prior studies. Viridian is also conducting a second Phase 3 trial, REVEAL-2, with topline data expected in the second half of 2026.
