Viridian Therapeutics Submits Investigational New Drug Application for VRDN-001, an IGF-1R antibody for the treatment of Thyroid Eye Disease, to the U.S. Food and Drug Administration
– VRDN-001 program remains on track for key proof of concept clinical data in Thyroid Eye Disease patients in the second quarter of 2022 –
Excerpt from the Press Release:
WALTHAM, Mass., Oct. 14, 2021 (GLOBE NEWSWIRE) — Viridian Therapeutics, Inc. (NASDAQ: VRDN), a biopharmaceutical company advancing new treatments for patients suffering from serious diseases underserved by today’s therapies, announced today the submission of an investigational new drug (IND) application to the United States Food and Drug Administration (FDA). The Company is seeking authorization to initiate a Phase 1/2 clinical trial of VRDN-001, an anti-insulin-like growth factor-1 receptor (IGF-1R) monoclonal antibody in development for the treatment of thyroid eye disease (TED), a debilitating disease that can cause proptosis (bulging eyes), double vision, and potential blindness.
The Company believes this clinical trial could provide key proof of concept clinical data in TED patients, with the potential to show clinically meaningful improvements in signs and symptoms of TED, including proptosis. The Company expects to announce top line clinical data from the proof of concept portion of the proposed trial in the second quarter of 2022.
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