Viridian Therapeutics plans to initiate two phase 3 clinical trials (REVEAL-1 and REVEAL-2) for VRDN-003, an anti-IGF-1R antibody, in August 2024. The trials will evaluate VRDN-003 for treating moderate-to-severe thyroid eye disease (TED).
VRDN-003 is designed to be administered subcutaneously as infrequently as every eight weeks. The company believes this convenience factor could enhance patient access and adherence to treatment.
REVEAL-1 will involve around 84 patients randomized into three groups: placebo, VRDN-003 every four weeks, and VRDN-003 every eight weeks. REVEAL-2 will involve approximately 126 patients randomized in the same manner. The primary efficacy endpoint for both trials will be the proportion of patients achieving a minimum 2mm improvement in proptosis (eye protrusion) from baseline at week 24.
Topline results from both trials are expected in the first half of 2026. If successful, Viridian aims to file a Biologics License Application (BLA) by the end of 2026. The company intends to launch VRDN-003 with an autoinjector pen for convenient administration.
Viridian believes VRDN-003 has the potential to be a best-in-class treatment for TED, offering the convenience of subcutaneous dosing and potentially improving outcomes for patients.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
