Viridian Therapeutics Announces First Patient Enrolled in the THRIVE Phase 3 Trial in Patients With Thyroid Eye Disease

Viridian Therapeutics announced that the first patient has been enrolled in its THRIVE phase 3 trial evaluating the efficacy and safety of the investigational agent VRDN-001 in patients with active thyroid eye disease (TED). The global THRIVE phase 3 trial will be conducted in approximately 50 centers across North America and Europe.

"We are pleased to enroll the first patient in the THRIVE trial, which is designed to confirm the compelling early results we’ve seen in TED patients," said Jonathan Violin, PhD, President and CEO of Viridian Therapeutics. "The study is a significant milestone for Viridian, and reinforces our commitment to the TED community. It is an important and meaningful step in our efforts to provide new and improved treatment options to patients with TED."

The THRIVE phase 3 trial is a double-blind, placebo-controlled, randomized study enrolling approximately 120 patients with active TED. The study participants will be randomized 1:1:1 across three arms: VRDN-001 10 mg per kilogram administered once every 3 weeks for 8 cycles, an accelerated course of VRDN-001 10 mg per kilogram administered once every 3 weeks for 5 cycles, and a placebo arm.

The primary efficacy endpoint for THRIVE is proptosis (eye bulging) responder rate, defined as the proportion of patients who achieve a reduction of proptosis of at least 2 millimeters compared to baseline at week 24. Secondary endpoints include overall response rate, change in proptosis as measured by exophthalmometer and magnetic resonance imaging (MRI), change in clinical activity score, and rate of diplopia resolution. Following week 24, trial participants may roll over into an open-label extension study followed by a longer-term registry study.

Viridian Therapeutics is also planning a second global phase 3 trial in patients with chronic TED called THRIVE-2. The THRIVE and THRIVE-2 phase 3 trials will support global health authority registration for marketing approval in both active and chronic TED.

VRDN-001 is an investigational therapy not approved for any use in any country.