Viridian Therapeutics has announced the completion of subject enrolment for its Phase III THRIVE-2 clinical trial of VRDN-001, aimed at treating patients with chronic thyroid eye disease (TED).
The trial enrolled a total of 188 patients worldwide, surpassing the initial target of 159 due to high patient interest.
Go deeper with GlobalData
Discover B2B Marketing That Performs
Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms.
Approximately 40% of participants were recruited from sites in the US.
The company is on schedule to present the topline readout from the THRIVE-2 by the end of the year.
Viridian earlier reported that its Phase III THRIVE trial for VRDN-001 in active TED completed enrolment in March with about half of the patients coming from the US.
The topline data from this trial is anticipated in September this year.
US Tariffs are shifting - will you react or anticipate?
Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis.
By GlobalDataVRDN-001, the leading product candidate of the company, is a monoclonal antibody for intravenous administration that fully antagonises the insulin-like growth factor-1 receptor (IGF-1R). It is said to be a validated target for TED.
The product is said to have the ability to enhance the patient experience through a dosing regimen that requires shorter infusion times and fewer infusions compared to the existing approved IGF-1R inhibitor.
Viridian president and CEO Steve Mahoney said: “We are very pleased with our overall clinical trial enrolment for the VRDN-001 trials. THRIVE and THRIVE-2 have now each exceeded their enrolment 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.”
Last month, the company announced plans to begin two Phase III clinical trials of the anti-IGF-1R antibody, VRDN-003, to treat moderate-to-severe TED.
Named REVEAL-1 and REVEAL-2, the trials aim to assess the efficacy and safety of the subcutaneous doses of VRDN-003 in people with both active and chronic TED, respectively.
