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Viridian Therapeutics Announces First Subject Dosed in Phase 1/2 Clinical Trial of VRDN-001 for Thyroid Eye Disease (TED)
- VRDN-001 targets and blocks IGF-1R, the only mechanism of action proven to deliver efficacy in TED -- Trial is on track to deliver top line proof of concept
About this update from Viridian Therapeutics, Inc.
[{"type":"text","content":"- VRDN-001 targets and blocks IGF-1R, the only mechanism of action proven to deliver efficacy in TED -- Trial is on track to deliver top line proof of concept clinical data in 2Q 2022 - WALTHAM, Mass., Dec. 20, 2021 (GLOBE NEWSWIRE) -- Viridian Therapeutics, Inc. (NASDAQ: VRDN), a biotechnology company advancing new treatments for patients suffering from serious diseases underserved by current therapies, today announced the first subject was dosed in a Phase 1/2 proof-of-concept clinical trial for VRDN-001, a monoclonal antibody that blocks the IGF-1 receptor with sub-nanomolar potency. IGF-1R blockade is a clinically validated mechanism of action for the treatment of TED. The Phase 1/2 trial is designed to evaluate safety, tolerability, pharmacokinetics, and potential efficacy of VRDN-001. The trial includes both healthy volunteers and randomized, placebo-controlled cohorts of TED patients and will assess multiple measures of the signs and symptoms of TED, including proptosis – the bulging of eyes characteristic of TED. The Company expects to announce top line data from the proof-of-concept portion of the trial in the second quarter of 2022. The trial protocol allows for additional TED patient cohorts to assess differing treatment paradigms that may offer advantages over currently available therapies and may reduce the burden of patient treatment. “We are excited to initiate our first clinical trial of VRDN-001. This trial is designed to quickly assess the potential of VRDN-001 to offer a new option for patients suffering from TED, and to inform how we can optimize VRDN-001 development to best meet patients’ needs,” stated Jonathan Violin, Ph.D., Viridian Therapeutics’ President and CEO. “VRDN-001 exemplifies Viridian’s patient-centric model of innovation that leverages proven biology and technology to efficiently craft medicines to meet the needs of patients and healthcare providers.” The clinical development plan for VRDN-001 was informed by safety, tolerability, pharmacokinetic, and pharmacodynamic data from more than 100 oncology patients who were previously administered this antibody under the name AVE1642. 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 pro...