Viridian Therapeutics Submits IND Application for VRDN-002 to the US FDA
Viridian Therapeutics, Inc. recently announced the submission of an investigational new drug (IND) application to the US 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.
“This IND filing is an important step in the development of VRDN-002 and our broader clinical strategy execution for potential treatments for TED patients,” said Jonathan Violin, PhD, Viridian Therapeutics’ President and CEO. “2022 will be a significant year for Viridian. We have multiple upcoming clinical milestones in the year beginning with data from the Phase 1/2 proof of concept trial for VRDN-001 in the second quarter of 2022, followed by data from the planned Phase 1 trial for VRDN-002 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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