Viridian’s Enrollment Completion of REVEAL Clinical Trials

Image Credits: Ophthalmology Times

Announcement

Viridian Therapeutics Inc., a leading biotechnology company committed to developing, commercializing, and exploring capable medicines for rare and serious diseases, has completed the enrollment process in REVEAL-1 and REVEAL-2. These are the phase 3 clinical trials for VRDN-003 in chronic and active TED patients. The VRDN-003 is a hypodermically delivered, monoclonal, half-life extended antibody focusing on the insulin-like growth factor-1 receptor (IGF-1R).

Enrollment Procedure

Thyroid eye disease (TED) portfolio following the VRDN-003 enrollment, completed in REVEAL-1 and REVEAL-2. The REVEAL-1 and REVEAL-2 enrolled around 132 and 204 patients each, extending their aimed enrollment of 117 and 195 patients. In REVEAL-1, around 67% were enrolled from the US, and 56% in REVEAL-2 same enrolled from the US. The highlighted data from the studies is lined up for the first half of 2026. Following the BLA submission is planned for next year. On the approval, the VRDN-003 will be launched with a commercial stamp, a low-volume autoinjector enabling patients to self-monitor at home. The composition of matter received a reward by the USPTO with a term to 2041 and the capability to expand exclusivity.

Additionally, the investigational new drug (IND) submission is lined up for the year-end 2025. The VRDN-008 highlights a sustained IgG decline in head-to-head efgartigimod and longer half-life after one high dose in non-human primates. Also, VRDN-006 gained IgG reduction proof-of-concept in healthy individuals. With the enrollment completion, the company is aiming for drug development.

Views and Statements from a Biotech Leader

Virdian’s president and chief executive officer, Steve Mahoney, said, “We are excited to consistently maintain Virdian’s track record of robust enrollment in TED clinical trials with around 330 TED patients in these two studies, which brings the total number of TED patients involved in Virdian’s clinical trials this year to 500. The REVEAL-1 and REVEAL-2 are beyond their veligrotug counterparts. REVEAL-2 is a huge global phase 3 clinical trial held in TED to date. Integrating with the large number of patients in every study enrolling from the US, we hope these results will be powerful enough to indicate the patients' demand for VRDN-003.” He further added, “With veligrotug heading towards a BLA submission and a breakthrough therapy designation contributing eligibility for priority review, we see the VRDN-003 and veligrotug's potency to develop a new standard of care for patients. We thank every patient, clinical trial, and caregiver who are joining in our clinical studies.”