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Viridian Therapeutics Announces Details of Subcutaneous VRDN-003 Phase 3 Clinical Program for Patients with Active and Chronic Moderate-to-Severe Thyroid Eye Disease
- On track to initiate two phase 3 clinical trials of VRDN-003 in August 2024 - - REVEAL-1 and REVEAL-2, will evaluate two active dosing regimens of
About this update from Viridian Therapeutics, Inc.
[{"type":"text","content":"\n- On track to initiate two phase 3 clinical trials of VRDN-003 in August 2024 -\n\n\n- REVEAL-1 and REVEAL-2, will evaluate two active dosing regimens of subcutaneously (SC) administered VRDN-003 in active and chronic thyroid eye disease (TED), with topline readout anticipated in the first half of 2026 for both trials -\n\n\n- VRDN-003 Biologics License Application (BLA) submission anticipated by year-end 2026 -\n\n\n- VRDN-003 is the only half-life extended anti-IGF-1R antibody in clinical development with the potential for convenient SC dosing as infrequently as every 8 weeks, for a total of 3 administrations -\n\n\n WALTHAM, Mass.--(BUSINESS WIRE)--\nViridian Therapeutics, Inc. (NASDAQ: VRDN), a biotechnology company focused on discovering and developing potential best-in-class medicines for serious and rare diseases, today reported details of its plans to initiate a phase 3 clinical trial program for its SC VRDN-003 product candidate for patients with moderate-to-severe TED.\n\n\n“We are very pleased to have completed a positive Type C meeting with the FDA and to take this next step towards rapidly bringing a highly differentiated treatment option to patients living with TED,” said Steve Mahoney, Viridian’s President and Chief Executive Officer. “We view VRDN-003 as a potentially best-in-class anti-IGF-1R product candidate that is designed to preserve the compelling IGF-1R clinical response we have seen in our earlier proof-of-concept studies of VRDN-001. We believe this product profile could maximize convenience as a low-volume, infrequent subcutaneous injection and provide better access to treatment for patients.”\n\n\nPhase 3 Clinical Trials in Active and Chronic TED\n\n\nViridian is planning to initiate two randomized, double-masked, placebo-controlled phase 3 clinical trials designed to evaluate the efficacy and safety of subcutaneously administered VRDN-003 in patients with active and chronic TED, named REVEAL-1 and REVEAL-2, respectively. These clinical trials are expected to initiate in August 2024.\n\n\nIn REVEAL-1, approximately 84 patients will be randomized in a 1:1:1 ratio to receive VRDN-003 SC or placebo every 4 weeks or every 8 weeks. Patients will receive an initial 600mg loading dose given as two 300mg injections, followed by single injections of 300mg thereafter for a total of 6 administrations in the 4-...