The FDA has signed off Viridian Therapeutics Inc's (NASDAQ:VRDN) 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 the administration as a convenient, low-volume, subcutaneous (SC) injection for the treatment of thyroid eye disease (TED).
- The Company will proceed with its planned Phase 1 trial of VRDN-002, a single ascending dose study to explore the safety, tolerability, pharmacokinetics, and pharmacodynamics of 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.
- The Company is also conducting a Phase 1/2 proof-of-concept trial for VRDN-001, a monoclonal antibody that blocks the IGF-1 receptor with sub-nanomolar potency for thyroid eye disease.
- Topline data is expected in Q2 2022.
- Price Action: VRDN shares are trading at 1.91% higher at $18.68 during the market session on the last check Monday.
