Viridian Completes THRIVE-2 Enrollment for Chronic TED Therapy VRDN-001

Viridian Therapeutics, Inc. (NASDAQ: VRDN), a biotechnology firm dedicated to the discovery and development of potential leading-edge treatments for serious and rare diseases, has announced the completion of patient enrollment in its THRIVE-2 phase 3 clinical trial for VRDN-001, aimed at patients suffering from chronic Thyroid Eye Disease (TED). The trial enrolled 188 patients globally, surpassing its original target of 159 due to high patient demand. Notably, around 40% of these patients were from sites in the United States. The company anticipates releasing topline data from this trial by the end of 2024.

Previously, in March 2024, Viridian had also completed and exceeded enrollment for the THRIVE trial, targeting patients with active TED. Around half of the participants in this trial were from the US. The topline data for the THRIVE trial is expected to be available by September 2024.

Steve Mahoney, the President and Chief Executive Officer of Viridian Therapeutics, expressed satisfaction with the robust enrollment for their VRDN-001 trials. He noted the successful enrollment in both THRIVE and THRIVE-2, attributing the high numbers to significant patient interest in the US. Mahoney also highlighted the company's readiness to begin two additional phase 3 clinical trials, REVEAL-1 and REVEAL-2, for their subcutaneous VRDN-003, scheduled to commence in August.

VRDN-001, Viridian’s leading product candidate, is an intravenously administered monoclonal antibody that fully antagonizes the insulin-like growth factor-1 receptor (IGF-1R). This target is clinically and commercially validated for treating TED, which generated approximately $1.8 billion in US revenues in 2023. VRDN-001 promises to enhance patient experience by offering a dosing regimen that requires shorter infusion times and fewer infusions compared to the currently marketed IGF-1R inhibitors. The drug is being evaluated in two global phase 3 clinical trials, THRIVE and THRIVE-2, for active and chronic TED, respectively.

Both THRIVE and THRIVE-2 trials are structured to compare a five-dose VRDN-001 treatment arm with a placebo, with doses administered three weeks apart. Phase 2 trials demonstrated that VRDN-001 improved TED signs and symptoms after six weeks from two infusions across all dosage groups, and the drug was generally well-tolerated. Viridian believes that, if approved, VRDN-001 could secure a significant position in the multi-billion-dollar TED market, facilitating the introduction of VRDN-003, a potential best-in-class subcutaneous IGF-1R antibody for TED.

Viridian Therapeutics, based in Waltham, Massachusetts, specializes in developing advanced treatments for severe and rare diseases, leveraging its expertise in antibody discovery and protein engineering. The company is actively advancing multiple candidates for treating TED, including VRDN-001 and VRDN-003, which are currently in pivotal global phase 3 trials. Additionally, Viridian is exploring a novel portfolio of neonatal Fc receptor (FcRn) inhibitors, such as VRDN-006 and VRDN-008, aimed at various autoimmune diseases.

Viridian continues to push forward with its clinical programs and aims to provide new therapeutic options for patients with significant unmet medical needs.