Viridian's Thyroid Eye Disease Candidate Shows Encouraging Early Data, Shares Surge

Viridian's Thyroid Eye Disease Candidate Shows Encouraging Early Data, Shares Surge
  • Viridian Therapeutics Inc VRDN has announced initial data from the 10mg/kg cohort in its ongoing Phase 1/2 trial of VRDN-001 for thyroid eye disease (TED), a rare autoimmune disease in which the body's immune system attacks the tissues around and behind the eyes.
  • Significant and rapid improvement in both signs and symptoms of TED at week six after two infusions of 10mg/kg VRDN-001.
  • Proptosis (bulging eyes) response was achieved by 83% of patients with a mean reduction of 2.4mm from baseline.
  • A clinical Activity Score of 0 or 1 was achieved by 83% of patients with a mean reduction of 4.3 points from baseline.
  • 75% of the patients achieved complete resolution of diplopia (double vision).
  • Demonstrated a favorable safety and tolerability profile with no reported SAEs, no hyperglycemia, and no infusion reactions.
  • Two cases of mild muscle spasms were reported and did not require intervention. One report of "ringing in the ears" resolved within two weeks without intervention.
  • No serious adverse events were reported in the ongoing TED cohort, evaluating two infusions of 20mg/kg of VRDN-001.
  • Data from the 3mg/kg cohort is expected in Q4 of 2022.
  • The first VRDN-001 Phase 3 trial (THRIVE) in active TED patients is expected to initiate by the end of 2022, with topline data expected in mid-year 2024. 
  • The second VRDN-001 Phase 3 trial (THRIVE-2) in chronic TED is expected to initiate in 1H of 2023, with topline data by the end of 2024.
  • Price Action: VRDN shares are up 31.4% at $19.35 during the premarket session on the last check Monday.

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