Viridian Reports Positive Long-Term Data from Phase 3 Veligrotug Trial in Thyroid Eye Disease

Viridian Therapeutics, Inc., a biopharmaceutical company based in Waltham, Massachusetts, has revealed positive long-term results from its THRIVE phase 3 clinical trial. This study focuses on veligrotug, an intravenously administered antibody targeting the insulin-like growth factor-1 receptor (IGF-1R), designed for patients suffering from active thyroid eye disease (TED). TED is an autoimmune condition that leads to inflammation and tissue damage around the eyes. The trial evaluates the efficacy of veligrotug through five infusions given every three weeks, with a primary analysis at week 15 and follow-up until week 52.

Steve Mahoney, President and CEO of Viridian, expressed confidence in the durability and safety data from the trial, suggesting that veligrotug is on track to become the preferred treatment for TED patients if approved. The company aims to submit a Biologics License Application (BLA) in the latter half of the year, with an eye toward a potential commercial launch in 2026.

The company’s phase 3 clinical trials, THRIVE and THRIVE-2, have demonstrated that veligrotug meets all primary and secondary endpoints. The trials reported a rapid onset of therapeutic effects, showing significant improvement in symptoms such as diplopia, a common issue for TED patients. THRIVE-2 marked the first instance of a global phase 3 trial indicating statistically significant relief from diplopia among chronic TED patients. This makes these trials the most extensive programs conducted for TED to date.

Veligrotug is designed to be a leading intravenous treatment for both active and chronic TED. It targets IGF-1R, a validated target both clinically and commercially, which saw U.S. revenues of approximately $2 billion in 2024. Veligrotug’s differentiated dosing regimen is notable for its fewer and shorter infusions compared to currently approved IGF-1R inhibitors, potentially enhancing patient experience.

The robust clinical profile of veligrotug positions it strongly in the TED market, should it receive approval. This could also aid in the introduction of VRDN-003, a promising subcutaneous therapy for TED under Viridian’s development.

Viridian is dedicated to creating innovative treatments for serious and rare diseases. Their expertise in antibody discovery and protein engineering allows them to develop unique therapeutic candidates for previously validated drug targets in established disease areas. Alongside veligrotug, the company is advancing VRDN-003 through its REVEAL-1 and REVEAL-2 trials to further evaluate its efficacy in active and chronic TED patients.

Beyond their focus on TED, Viridian is also developing a novel range of neonatal Fc receptor (FcRn) inhibitors, such as VRDN-006 and VRDN-008, which hold potential for treatment across multiple autoimmune diseases.

Viridian’s work reflects a commitment to advancing care in areas of unmet medical need, aiming to bring transformative treatments to patients suffering from rare and serious conditions.