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Viridian Announces Positive Data from Ongoing Phase 1/2 Trial Evaluating VRDN-001 in Patients with Thyroid Eye Disease (TED)
- Significant and rapid improvement in both signs and symptoms of TED after two infusions of 20 mg/kg VRDN-001, generally consistent with 10 mg/kg results at
About this update from Viridian Therapeutics, Inc.
[{"type":"text","content":"- Significant and rapid improvement in both signs and symptoms of TED after two infusions of 20 mg/kg VRDN-001, generally consistent with 10 mg/kg results at week 6 - - Global Phase 3 THRIVE clinical program initiated - - Across all VRDN-001 treated patients to date: 75% were proptosis responders, 75% were overall responders, 58% achieved a Clinical Activity Score (CAS) of 0 or 1, and 75% had complete resolution of their diplopia - - Safety profile favorable at 20 mg/kg dose, with no reported SAEs, no drug-related hyperglycemia, no hearing impairment, and no infusion reactions - - Low volume SC programs on track for proof-of-concept data in 2H23; final Phase 1 data for VRDN-002 demonstrates half-life up to 43 days - - Company well capitalized with cash, cash equivalents, and short-term investments of $431M, providing cash runway into 2H25 - WALTHAM, Mass., Nov. 14, 2022 (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 positive topline clinical data from the first two cohorts in its ongoing Phase 1/2 clinical trial of VRDN-001, an anti-IGF-1R antibody, in patients with active thyroid eye disease (TED). TED is a rare autoimmune disease in which the body’s own immune system attacks the tissues around and behind the eyes causing inflammation, swelling, and damage that develops into debilitating signs and symptoms including double vision, bulging eyes, and ocular pain. “These additional Phase 1/2 clinical data continue to support the potential for VRDN-001 to be a new treatment option for patients suffering from TED,” said Raymond Douglas, M.D., Ph.D., director of the Orbital and Thyroid Eye Disease Program, Cedars-Sinai Medical Center and an investigator on the VRDN-001 trial. “The data show that a majority of patients experienced meaningful improvements in proptosis and clinical activity score, and complete resolution of diplopia after only two infusions of VRDN-001, with initial data suggesting a prolonged duration of benefit. This profile could offer substantial benefits to patients.” VRDN-001 – Phase 1/2 proof-of-concept trialThe double-blind, placebo-controlled Phase 1/2 trial is evaluating two infusions of VRDN-001 administered intravenously, three weeks apart, with effi...