Viridian Therapeutics – Positive Phase 3 Results for Veligrotug in Chronic Thyroid Eye Disease

By Tamara Parker • Monday, December 16 15:21 • Permanent Link

Viridian Therapeutics, Inc. has recently announced positive topline results from the phase 3 Thrive-2 clinical trial of Veligrotug (Veli), an intravenously delivered anti-insulin-like growth factor-1 receptor (IGF-1R) antibody, in patients with chronic thyroid eye disease (TED). The trial demonstrated impressive efficacy and safety outcomes, meeting all primary and secondary endpoints with high statistical significance.

In the Thrive-2 trial, Veligrotug achieved a week 15 proptosis responder rate (PRR) of 56%, with a placebo-adjusted PRR of 48% (p < 0.0001). Additionally, the study showed a statistically significant and clinically meaningful 56% diplopia responder rate, with a placebo-adjusted rate of 31% (p = 0.0006), and a 32% rate of diplopia complete resolution, with a placebo-adjusted rate of 18% (p = 0.0152).

The trial enrolled a total of 188 patients, randomized to receive Veligrotug or placebo. The mean time since onset of TED in this patient population was 69.8 months. Notably, Veligrotug was generally well-tolerated, with 94% of patients completing their treatment course and a 9.6% placebo-adjusted rate of hearing impairment.

The company also reported a strong cash position of $753 million as of September 30, 2024, providing cash runway into the second half of 2027. Viridian is on track for the BLA submission for Veligrotug in the second half of 2025.

Veligrotug’s differentiated clinical profile demonstrated in the broadest population studied in a global phase 3 study across active and chronic TED patients to date has the potential to transform the standard of care in TED.

The company anticipates reporting topline data from the global phase 3 clinical trials of subcutaneous VRDN-003 in the first half of 2026, with a BLA submission in the second half of 2026. VRDN-003 is a half-life-extended anti-IGF-1R antibody with the same binding domain as Veligrotug.

The market has reacted to these announcements by moving the company's shares 22.4% to a price of $21.85. For more information, read the company's full 8-K submission here.

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