Viridian Therapeutics Announces FDA Clearance of Investigational New Drug Application to Initiate Clinical Development of VRDN-002, a Next-Generation IGF-1R Antibody for the Treatment of Thyroid Eye Disease
Viridian Therapeutics, Inc. recently announced the US 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.
“We are excited to advance our VRDN-002 clinical development plan. We believe the incorporation of half-life extension technology into VRDN-002 may enable a differentiated, low volume subcutaneous injection, offering TED patients improved convenience and broader settings of care,” stated Jonathan Violin, Ph.D., Viridian Therapeutics’ President and CEO. “This IND acceptance is the first of multiple regulatory, clinical, and operational milestones expected in 2022, including top-line data from our VRDN-001 Phase 1/2 proof of concept trial in the second quarter of 2022, and top-line data from our VRDN-002 Phase 1 trial in mid-2022.”
Viridian Therapeutics is a biotechnology company advancing new treatments for patients suffering from serious diseases but underserved by today’s therapies. Viridian’s most advanced program, VRDN-001, is a differentiated monoclonal antibody targeting insulin-like growth factor-1 receptor (IGF-1R), a clinically and commercially validated target for the treatment of thyroid eye disease (TED). Viridian’s second product candidate, VRDN-002, is a distinct anti-IGF-1R antibody that incorporates half-life extension technology and is designed to support administration as a convenient, low-volume, subcutaneous injection. TED is a debilitating autoimmune disease that causes inflammation and fibrosis within the orbit of the eye which can cause double vision, pain, and potential blindness. Patients with severe disease often require multiple remedial surgeries to the orbit, eye muscles and eyelids. Viridian is based in Waltham, MA.
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