- THRIVE-2 exceeded its enrollment target due to patient demand; 188 patients enrolled with approximately 40% from US sites -
- THRIVE topline readout in patients with active TED on track for September 2024 -
- THRIVE-2 topline readout on track for year-end 2024
Viridian Therapeutics, Inc. announced that enrollment is complete in THRIVE-2, its phase 3 clinical trial for VRDN-001 in patients with chronic TED.
THRIVE-2 enrolled 188 patients globally and exceeded the enrollment target of 159 patients due to patient demand. Approximately 40% of the enrolled patients were from US sites.
Topline data from THRIVE-2 is on track for readout by year-end 2024. Previously, Viridian announced that THRIVE, its phase 3 clinical trial for VRDN-001 in patients with active TED, completed and exceeded enrollment in March 2024 with approximately 50% of patients enrolled from US sites. Topline data for THRIVE is on track for readout in September 2024.
“We are very pleased with our overall clinical trial enrollment for the VRDN-001 trials,” said Steve Mahoney, Viridian’s president and CEO. “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.”
About VRDN-001
Viridian’s lead product candidate, VRDN-001, is an intravenously (IV) delivered monoclonal antibody that acts as a full antagonist of the insulin-like growth factor-1 receptor (IGF-1R). IGF-1R is a clinically and commercially validated target for thyroid eye disease (TED) that had US revenues of approximately $1.8 billion in 2023. VRDN-001 has the potential to improve patient experience with a differentiated dosing regimen that features a shorter infusion time and fewer infusions compared to the currently approved and marketed IGF-1R inhibitor.
Viridian is evaluating VRDN-001 in two global phase 3 clinical trials, THRIVE and THRIVE-2, for the treatment of active and chronic TED, respectively. THRIVE and THRIVE-2 are each designed to compare a five-dose treatment arm of VRDN-001 to placebo, each dosed three weeks apart. In phase 2 clinical trials in active and chronic TED, VRDN-001 was shown to improve the signs and symptoms of TED at six weeks after two infusions in all dose cohorts and was generally well-tolerated.
Viridian believes that the differentiated VRDN-001 has the potential to establish a strong foothold in the multi-billion-dollar TED commercial market, if approved, and will help facilitate the introduction of VRDN-003, its potential best-in-class subcutaneous IGF-1R antibody for TED.