Viridian Therapeutics announces plans for clinical trial program evaluating VRDN-003 in TED treatment

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Two randomized, double-masked, placebo-controlled, Phase 3 trials named REVEAL-1 and REVEAL-2 are expected to start in August 2024.

(image Credit: AdobeStock/Dilok)

(image Credit: AdobeStock/Dilok)

Viridian Therapeutics has released details on its planned Phase 3 clinical trial program evaluating VRDN-003 for patients with moderate-to-severe Thyroid Eye Disease (TED).

According to the company, the announcement of the trials comes following a “positive Type C meeting with the FDA.”

Two randomized, double-masked, placebo-controlled, Phase 3 trials named REVEAL-1 and REVEAL-2 are expected to start in August 2024. They will be evaluating the efficacy and safety of subcutaneously administered VRDN-003 in patients with active and chronic TED.1

The REVEAL-1 trial will have approximately 84 patients and be randomized in a 1:1:1 ratio where patients will receive VRDN-003 SC or placebo every 4 weeks or every 8 weeks. Patients in the REVEAL-1 trial will receive an initial 600mg loading dose given as 2 separate 300mg injections. This will be followed by single injections of 300mg for a total of 6 injections in 4 weeks.1

The REVEAL-2 trial will have approximately 126 patients enrolled and will be randomized in the same manner as the REVEAL-1 trial for the same dosing regimens.1

The primary endpoint in both trials will be proptosis responder rate, which will be based on the achievement of at least 2mm improvement in proptosis from baseline at week 24, versus placebo. Patients will be followed for an additional 28 weeks. Furthermore, additional outcome measures in each trial will include changes from baseline in proptosis, clinical activity score (CAS), and diplopia.1

“The current standard of care in TED requires 8 intravenous doses, representing a significant burden for patients,” said Tom Ciulla, Viridian’s Chief Medical Officer in a press release from the company. “Subcutaneous VRDN-003 could transform the treatment experience for patients with TED.”

At the end of 2023, Viridian announced it would be moving forward with VRDN-003 as its lead subcutaneous program for TED based on positive data from a Phase 1 clinical study in healthy volunteers. The Phase 1 results showed a VRDN-003 half-life of 40-50 days which is 4-5x the half-life of VRDN-001, another product from Viridian. With the announcement of VRDN-003 moving forward as the lead candidate, Viridian also stated it was the goal to advance VRDN-001 as a best-in-class IV therapy.

VRDN-003 is a subcutaneously administered anti-IGF-1R antibody. According to the company, IGF-1R inhibition is the only approved mechanism of action that has been clinically and commercially validated for TED and has shown to be highly effective in treating the disease.

Viridian stated it anticipates topline data for both clinical trials to be available in the first half of 2026 and to file a BLA by the end of 2026.1

References:
  1. Viridian Therapeutics Announces Details of Subcutaneous VRDN-003 Phase 3 Clinical Program for Patients with Active and Chronic Moderate-to-Severe Thyroid Eye Disease. Press release; June 11, 2024. Accessed June 11, 2024. https://www.businesswire.com/news/home/20240611897132/en/Viridian-Therapeutics-Announces-Details-of-Subcutaneous-VRDN-003-Phase-3-Clinical-Program-for-Patients-with-Active-and-Chronic-Moderate-to-Severe-Thyroid-Eye-Disease
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