Viridian Therapeutics Announces FDA Clearance of Investigational New Drug (IND) Application for VRDN-001, an IGF-1R Antibody for the Treatment of Thyroid Eye Disease (TED)

  • Phase 1/2 proof of concept trial for VRDN-001 is expected to report top line clinical data in the second quarter of 2022

WALTHAM, MA, USA I November 15, 2021 I Viridian Therapeutics, Inc. (NASDAQ: VRDN) (the “Company” or “Viridian”), a biotechnology company advancing new treatments for patients suffering from serious diseases underserved by current therapies, today announced the U.S. Food and Drug Administration (“FDA”) clearance of its Investigational New Drug (“IND”) application for VRDN-001, which the Company is developing for the treatment of thyroid eye disease (TED).

VRDN-001 is a monoclonal antibody that binds and blocks the IGF-1R signaling pathway with sub-nanomolar affinity. This mechanism of action is clinically and commercially validated for the treatment of TED. The Company’s first clinical trial for VRDN-001 is a Phase 1/2 proof of concept trial including multiple randomized, placebo-controlled cohorts of TED patients to assess the potential for VRDN-001 to provide rapid improvement of signs and symptoms of TED, including proptosis. The protocol for this trial allows for additional patient cohorts to assess differing treatment paradigms that may offer advantages over currently available therapies and mitigate patient treatment burden. The Company expects to announce top line data from the proof of concept portion of the trial in the second quarter of 2022.

“Our first clinical trial for VRDN-001 is designed to rapidly test proof of concept while enabling data-driven evaluation of dosing paradigms that could offer TED patients new and differentiated therapeutic options. With the IND accepted by the FDA, we remain on track to report top line clinical data for VRDN-001 in the second quarter of 2022,” stated Jonathan Violin, Ph.D., Viridian’s President and CEO. “This is the first milestone in what we expect to be a busy 12 months as we advance the development of our clinical and preclinical pipeline of potential best in class therapeutics.”

About Viridian Therapeutics, Inc.

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, Massachusetts.

SOURCE: Viridian Therapeutics

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