VRDN - Viridian stock soars 39% as thyroid eye disease drug shows promise in trial

Viridian Therapeutics ( NASDAQ: VRDN ) said VRDN-001 was safe and showed clinical activity in an ongoing phase 1/2 trial in patients with with active thyroid eye disease (TED).

TED is a rare autoimmune disease in which the immune system attacks the tissues around the eyes causing inflammation and damage, which develops into symptoms of double vision, bulging eyes, and ocular pain, the company noted.

This ongoing trial is evaluating two infusions of VRDN-001 given intravenously. Each dose is evaluated in a group of eight patients, of which six receive VRDN-001 and two receive placebo.

In the group receiving a dose of 10mg/kg, VRDN-001 was well-tolerated by all patients and there were no reported serious adverse events. Two cases of mild muscle spasm were reported and did not require intervention, the company said in an Aug. 15 press release.

At week 6 on symptoms of Proptosis (bulging eyes): 83% proptosis responder rate was seen, defined as a ?2mm reduction in bulge of eyes from baseline; Rapid reduction with a median time to proptosis response of 3 weeks; 2.4mm average reduction in eye bulge from baseline.

In addition, the company said 83% of patients achieved maximal or near-maximal therapeutic effect on Clinical Activity Score (CAS), an assessment scales for TED.

Viridian added that 83% overall responder rate was seen, defined as a ?2mm reduction in proptosis and a ?2 point reduction in CAS.

The company noted that 75% complete resolution of diplopia (double vision) was seen.

"These data exceeded our expectations and compare very favorably to Tepezza, the only approved therapy in TED. The significant improvement in signs and symptoms observed after only two infusions of VRDN-001 is remarkable. We plan to accelerate the start of our Phase 3 THRIVE program, now starting later this year, in a broad TED population of both active and chronic disease," Viridian's  Chief Medical Officer Barrett Katz.

Tepezza is marketed by Horizon Therapeutics ( HZNP )

Meanwhile, in the ongoing second group evaluating 20mg/kg of VRDN-001, there were no adverse events of hyperglycemia (high blood sugar), muscle spasm, hearing impairment, infusion reactions, or any serious adverse events, Viridian added.

The company said a third group will evaluate a dose of 3mg/kg, with data expected in Q4 2022.

VRDN +39.17% to $20.50 premarket Aug. 15

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