Viridian Therapeutics Submits IND Application for an IGF-1R Antibody for the Treatment of Thyroid Eye Disease
Viridian Therapeutics, Inc. recently announced the submission of an investigational new drug (IND) application to the United States Food and Drug Administration (FDA). The company is seeking authorization to initiate a Phase 1/2 clinical trial of VRDN-001, an anti-insulin-like growth factor-1 receptor (IGF-1R) monoclonal antibody in development for the treatment of thyroid eye disease (TED), a debilitating disease that can cause proptosis (bulging eyes), double vision, and potential blindness.
The company believes this clinical trial could provide key proof of concept clinical data in TED patients, with the potential to show clinically meaningful improvements in signs and symptoms of TED, including proptosis. The Company expects to announce top line clinical data from the proof of concept portion of the proposed trial in the second quarter of 2022.
“Our IND filing is an important milestone as we continue to advance the development of VRDN-001 as a potential treatment for patients suffering from Thyroid Eye Disease. We look forward to launching this trial upon IND activation,” said Jonathan Violin, PhD, President and Chief Executive Officer of Viridian. “Our IND submission features a trial protocol designed to rapidly evaluate proof of concept, with flexibility to subsequently assess different doses and treatment regimens that may differentiate VRDN-001 from currently available therapies.”
VRDN-001, Viridian’s lead TED program, is an intravenously administered anti-IGF-1R monoclonal antibody. This antibody was previously in development as AVE1642 and was studied in more than 100 oncology patients. The pharmacokinetic, pharmacodynamic, safety, and tolerability data from the AVE1642 program inform Viridian’s development plans for VRDN-001.
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). 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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