Viridian Announces Positive Data From Phase 1/2 Trial Of Low Dose VRDN-001 In Thyroid Eye Disease

(RTTNews) - Viridian Therapeutics, Inc. (VRDN) announced positive topline clinical data from the third, low dose cohort in Phase 1/2 clinical trial of VRDN-001, an anti-insulin-like growth factor 1 receptor (IGF-1R) antibody, in patients with active thyroid eye disease or TED.

According to the company, the data supports development of VRDN-001 as a patient-friendly low volume subcutaneous injection, which could reduce the burden of care for patients suffering from TED.

The proof-of-concept portion of this double-blind, placebo-controlled Phase 1/2 trial evaluated two infusions of VRDN-001 administered intravenously, three weeks apart, with efficacy measured six weeks after the first dose. VRDN-001 was evaluated at doses of 3, 10, and 20 mg/kg, with each cohort designed to include six patients randomized to drug, and two patients randomized to placebo.

The company noted that among 3 mg/kg VRDN-001 treated patients, 67% were proptosis responders, 56% were overall responders, 67% achieved a Clinical Activity Score (CAS) of 0 or 1, and 20% had complete resolution of their diplopia.

The company specified that across all 21 VRDN-001 treated patients to date, 71% were proptosis responders, 67% were overall responders, 62% achieved a CAS of 0 or 1, and 54% had complete resolution of their diplopia, with a favorable safety profile seen across all dose levels

The company believes this data expand overall data set to 21 drug-treated patients and build additional confidence in our ongoing Phase 3 'THRIVE' trial evaluating VRDN-001 in patients with active TED.

The data also support the planned dosing interval for Viridian's VRDN-002 and VRDN-003 subcutaneous programs of up to once monthly.