Viridian Cleared to Initiate Clinical Development of Thyroid Eye Disease Antibody

 Viridian Therapeutics, Inc. (NASDAQ: VRDN), a biotechnology company advancing new treatments for patients suffering from serious diseases underserved by current therapies, today announced the United States Food and Drug Administration (FDA) clearance of its investigational new drug (IND) application of VRDN-002. The Company’s next generation IGF-1R antibody, VRDN-002, is a humanized monoclonal antibody that incorporates half-life extension technology and is designed to support administration as a convenient, low-volume, subcutaneous (SC) injection for the treatment of thyroid eye disease (TED).

The IND application clearance allows the Company to proceed with its planned first-in-human Phase 1 clinical trial of VRDN-002, which is a single ascending dose study to explore safety, tolerability, pharmacokinetics and pharmacodynamics of intravenously administered VRDN-002 in healthy volunteers. Data from this Phase 1 trial are expected to be announced in mid-2022 and will inform the feasibility of a low-volume and/or low-frequency SC dosing paradigm for TED patients.

https://finance.yahoo.com/news/viridian-therapeutics-announces-fda-clearance-120000270.html