Viridian Therapeutics Doses First Subject in First-in-Human Clinical Trial Evaluating a Next- Generation IGF-1R Antibody
Viridian Therapeutics, Inc. recently announced it has dosed the first subject in a Phase 1 clinical trial evaluating VRDN-002 for the treatment of thyroid eye disease (TED).
This is a first-in-human Phase 1 clinical trial of VRDN-002, 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 TED patients. The single ascending dose trial will explore safety, tolerability, pharmacokinetics and pharmacodynamics of intravenously administered VRDN-002 at doses of 3, 10, and 20 mg/kg in up to 16 healthy volunteers. Topline data from the trial are expected to be announced mid-year and will inform the feasibility of a low-volume SC dosing paradigm for TED patients.
“With VRDN-001 and VRDN-002, we are focused on developing a portfolio approach to advance patient care for TED patients. The initiation of this first-in-human trial of VRDN-002 delivers a key milestone as we execute our development strategy for VRDN-002 and ramp up clinical activity across our pipeline,” said Jonathan Violin, PhD, Viridian Therapeutics’ President and CEO. “Incorporating half-life extension technology that may enable SC administration is a significant step forward in the treatment of TED. The option of a SC injection would broaden the settings of care, either at home by patients via self-administration or in the prescribing physician’s office.”
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 humanized 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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