Viridian Therapeutics Inc (NASDAQ: 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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