Viridian completes enrollment in THRIVE-2 trial for chronic thyroid eye disease

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Viridian Therapeutics has completed enrollment in its phase 3 clinical trial, THRIVE-2 (NCT06021054), the company announced in a press release.¹

The THRIVE-2 trial has enrolled 188 patients globally. According to the company, approximately 40% of patients enrolled were from US sites. The trial is a randomized, double-masked, placebo-controlled safety, tolerability and efficacy study of VRDN-001 in participants with chronic thyroid eye disease (TED). It will compare a 5-dose treatment arm of VRDN-001 to placebo, each dosed 3 weeks apart.^1,2

In phase 2 clinical trials, VRDN-001 was shown to improve the signs and symptoms of TED at 6 weeks after 2 infusions in all dose cohorts and was generally well-tolerated.¹

Steve Mahoney, president and CEO of Viridian said in a press release the company is “very pleased with [their] overall clinical trial enrollment for the VRDN-001 trials.” Mahoney continued saying “THRIVE and THRIVE-2 have now each exceeded their enrollment targets and enrolled substantial patient numbers in the US due to patient demand. We look forward to our topline data readout for THRIVE in September and for THRIVE-2 at the end of this year. We are also on track to initiate two subcutaneous VRDN-003 phase 3 clinical trials, REVEAL-1 and REVEAL-2, in August as planned.”

VRDN-001 is an intravenously delivered monoclonal antibody that acts as a full antagonist of the insulin-like growth factor-1 receptor (IGF-1R).

The THRIVE trial (NCT05176639), separate from the THRIVE-2 trial, is evaluating VRDN-001 in active TED and completed enrollment in March 2024.^1,3

Topline data for the THRIVE-2 is expected to be available by year-end of 2024, while topline data from the THRIVE trial is expected in September 2024.

References:

1. Viridian Therapeutics Announces Completion of THRIVE-2 Enrollment for VRDN-001 in Patients with Chronic Thyroid Eye Disease (TED). Press Release; July 25, 2024. Accessed July 29, 2024. https://investors.viridiantherapeutics.com/news/news-details/2024/Viridian-Therapeutics-Announces-Completion-of-THRIVE-2-Enrollment-for-VRDN-001-in-Patients-with-Chronic-Thyroid-Eye-Disease-TED/default.aspx

2. A Randomized, Double-masked, Placebo-controlled Safety, Tolerability, and Efficacy Study of VRDN-001, a Humanized Monoclonal Antibody Directed Against the IGF-1 Receptor, in Participants With Chronic Thyroid Eye Disease (TED) (THRIVE-2). NCT06021054. https://www.clinicaltrials.gov/study/NCT06021054?spons=Viridian%20Therapeutics,%20Inc.&rank=1&page=1&limit=10

3. A Safety, Tolerability and Efficacy Study of VRDN 001 in Healthy Volunteers and Persons With Thyroid Eye Disease (TED) (THRIVE). NCT05176639. https://www.clinicaltrials.gov/study/NCT05176639?spons=Viridian%20Therapeutics,%20Inc.&rank=2&page=1&limit=10