Why Are Viridian Therapeutics Shares Falling Today

Viridian Therapeutics Inc VRDN released preliminary data from its ongoing Phase 1/2 trial of VRDN-001 for chronic thyroid eye disease (TED).

Patients in the 10 mg/kg (n=6) and 3 mg/kg (n=6) cohorts treated with two doses of VRDN-001 were evaluated for changes in proptosis (bulge), CAS, and diplopia (double vision) at week 6. 

VRDN-001 data demonstrated clinically meaningful and rapid improvement in signs and symptoms of chronic TED at week 6 after receiving two infusions of VRDN-001 10 mg/kg or 3 mg/kg.

Observed a 50% to 72% reduction in mean Clinical Activity Score (CAS) at week 6 compared with mean baseline levels in patients treated with VRDN-001.

Related: Viridian's Thyroid Eye Disease Candidate Shows Promise At Lower Doses

Five of the twelve VRDN-001 treated patients across both dose cohorts had diplopia at baseline. None of the patients treated with VRDN-001 achieved complete resolution of diplopia at week 6. Investors are probably reacting to this.

VRDN-001 was generally well tolerated by all drug-treated patients in both dose cohorts. 

The company also amended its ongoing THRIVE Phase 3 trial design and provided an update on the recent progress of its subcutaneous (SC) program candidates in TED.

THRIVE will now include the VRDN-001 5-dose treatment regimen and placebo arms only. The company expects to announce topline results in mid-2024.

Viridian plans to initiate the THRIVE-2 Phase 3 trial to evaluate the safety and efficacy of VRDN-001 in patients with chronic TED in Q3 2023, with topline data expected by the end of 2024.

Viridian says 3 mg/kg data support low-volume subcutaneous (SC) dosing profile for the company's SC candidates in TED, and it plans to select the lead SC program candidate by year-end 2023 and to advance the program into a pivotal Phase 2/3 trial in mid-2024.

Price Action: VRDN shares are down 18.10% at $20.08 during the premarket session on the last check Tuesday.