By Siddhi Mahatole
March 30 (Reuters) – Viridian Therapeutics said on Monday its experimental drug met the main goal in a late-stage study, when tested in patients with active thyroid eye disease.
Shares of the company, however, fell 36% in premarket trading.
Jefferies analyst Faisal Khurshid said the data reduces risk for Viridian since it now has two potential thyroid eye disease drugs, but there could be “fierce investor debate on commercial feasibility” as efficacy of the drug, elegrobart, fell short of rivals.
The 36% and 45% placebo-adjusted proptosis response rates came in below investor expectations of above 50%, while the double-vision data were harder to read and safety appeared acceptable, Khurshid added.
The injectable drug, elegrobart, was assigned to 132 patients in either of two dosing schedules – every four weeks or every eight weeks – or a placebo.
Thyroid Eye Disease, or TED, is an autoimmune condition causing inflammation, swelling, and fat expansion behind the eyes, often resulting in bulging, pain, redness, and double vision.
At 24 weeks, 54% of patients on the four-week dosing schedule showed an improvement in eye bulging, compared with 18% on placebo.
Patients also showed greater improvements in double vision, with 71% registering a response in the more frequent dosing arm versus 32% for placebo.
“We believe there is a significant opportunity with subcutaneous elegrobart in TED, including the potential to expand the market as an at-home and self-administered treatment option, if approved,” Chief Executive Steve Mahoney said.
The eight-week regimen also beat placebo, with 63% of patients showing an improvement in eye bulging and 54% reporting better double vision, compared with 18% and 32% on placebo respectively.
The company expects to submit a U.S. biologics license application for elegrobart in the first quarter of 2027.
The U.S. health regulator approved Amgen’s Tepezza, the only therapy for thyroid eye disease, in January 2020.
(Reporting by Siddhi Mahatole in Bengaluru; Editing by Shailesh Kuber)
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