Viridian Therapeutics completes enrollment in REVEAL-1 and REVEAL-2 clinical trials for VRDN-003

(Image Credit: AdobeStock/Antony Weerut)

Viridian Therapeutics announced it has completed enrollment in its REVEAL-1 and REVEAL-2, phase 3 clinical trials for VRDN-003 in patients with active and chronic thyroid eye disease (TED).

VRDN-003 is a subcutaneously delivered, half-life extended, potential best-in-class anti-IGF-1R antibody. Additionally, it has the same binding domain as veligrotug and was engineered to have a longer half-life.

REVEAL-1 enrolled 132 patients, while REVEAL-2 enrolled 204, with each exceeding the expected enrollment of 117 and 195 patients, respectively. According to the company, 67% of patients in REVEAL-1 and 56% of patients from REVEAL-2 are in the US.

Topline data from the trials is expected to be available in the first half of 2026.

Steve Mahoney, Viridian’s president and CEO, commented on the update in a press release from the company.

“Both REVEAL-1 and REVEAL-2 are larger than their veligrotug counterparts, and REVEAL-2 is the largest global phase 3 clinical trial conducted in TED to date. Taken together with the majority of patients in each study enrolling from the US, we believe these to be strong signals of patient demand for VRDN-003,” said Mahoney.

Viridian also noted that it plans to submit a Biologics License Application (BLA) for VRDN-003 by year-end of 2026. Additionally, if approved, the company plans to launch with a commercially validated, low-volume autoinjector, allowing patients to self-administer at home.

The company also updated its plans for veligrotug, stating it plans to submit a BLA in November of this year. The company noted it has the potential to commercially launch veligrotug in mid-2026 if approved under Priority Review, which is granted via the Breakthrough Therapy Designation, granted in May 2025.

References:

1. Viridian Therapeutics Announces Completion of Enrollment in both REVEAL Clinical Trials and Positive Portfolio Updates. Published September 15, 2025. Accessed September 15, 2025. https://investors.viridiantherapeutics.com/news/news-details/2025/Viridian-Therapeutics-Announces-Completion-of-Enrollment-in-both-REVEAL-Clinical-Trials-and-Positive-Portfolio-Updates/default.aspx