At Higher Dose, Viridian's Thyroid Eye Disease Candidate Shows Significant, Rapid Improvement In Signs & Symptoms

  • Viridian Therapeutics Inc VRDN announced topline clinical data from the first two cohorts in its ongoing Phase 1/2 clinical trial of VRDN-001 in active thyroid eye disease (TED). 
  • VRDN-001 was well-tolerated by all patients treated at the 20 mg/kg dose, with safety data consistent with the 10 mg/kg dose. 
  • Improvement in proptosis (bulging eyes), CAS (Clinical Activity Score), and diplopia (double vision) was generally consistent across the two cohorts. 
  • Related: Viridian's Thyroid Eye Disease Candidate Shows Encouraging Early Data, Shares Surge.
  • Across all VRDN-001 treated patients to date: 75% were proptosis responders, 75% were overall responders, 58% achieved a Clinical Activity Score (CAS) of 0 or 1, and 75% had complete resolution of their diplopia.
  • The company also reported 12-week data from the 10 mg/kg cohort, showing that after two infusions, VRDN-001 maintained efficacy for six additional weeks through week 12. 
  • This data further supports the potential for a shorter course of treatment via a 5-infusion schedule being studied alongside the standard 8 infusion arm in the company's Phase 3 THRIVE program.
  • Topline data from the 3 mg/kg cohort of active TED patients is expected in early January 2023
  • The company is also working on a subcutaneous (SC) injection program, VRDN-002, and is on track to deliver topline proof of concept data for VRDN-002 in TED patients in the second half of 2023.
  • Price Action: VRDN shares are down 2.93% at $19.91 on the last check Monday.
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