Viridian Therapeutics, Inc. announced the submission of an investigational new drug (IND) application to the United States Food and Drug Administration (FDA) for VRDN-002, a humanized monoclonal antibody that incorporates half-life extension technology and is designed to support administration as a convenient, low-volume, subcutaneous injection for the treatment of thyroid eye disease (TED). Viridian submitted the IND for VRDN-002 in December 2021. The company is seeking authorization to initiate a Phase 1 single ascending dose clinical trial to explore safety, tolerability, pharmacokinetics, and target engagement of intravenous VRDN-002 in healthy volunteers.

Data from this Phase1 trial aims to test the feasibility of a low-volume and/or low-frequency dosing paradigm and are expected to be announced in mid-2022.