- 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.
© 2024 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
Comments
Loading...
Benzinga simplifies the market for smarter investing
Trade confidently with insights and alerts from analyst ratings, free reports and breaking news that affects the stocks you care about.
Join Now: Free!
Already a member?Sign in