Viridian Therapeutics To Test Next-Gen IGF-1R Antibody In Thyroid Eye Disease


The FDA has signed off Viridian Therapeutics Inc's 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.
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Posted In: BiotechNewsHealth CareSmall CapFDAGeneralBriefsPhase 1 Trial
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