VRDN-001 for thyroid eye disease promising in phase 1/2 trial
Click Here to Manage Email Alerts
Key takeaways:
- VRDN-001 demonstrated improvements in proptosis and clinical activity score in patients with thyroid eye disease.
- No serious adverse events were reported.
VRDN-001 demonstrated positive preliminary results in the treatment of chronic thyroid eye disease in an ongoing phase 1/2 clinical trial, according to a press release from Viridian Therapeutics.
The trial is investigating two infusions of the full antagonist antibody administered intravenously at doses of 10 mg/kg and 3 mg/kg, with clinical activity endpoints measured at 6 weeks after the first infusion. Each cohort included six patients randomly assigned to receive VRDN-001 and two patients randomly assigned to receive placebo. Changes in proptosis, clinical activity score (CAS) and diplopia were recorded.
Patients who received VRDN-001 had a lower mean proptosis at baseline compared with those treated who received placebo, with the combined cohorts experiencing a mean reduction of –1.6 mm from baseline. Additionally, there was a reduction in mean CAS of 50% to 72% compared with mean baseline levels at week 6 in the VRDN-001 groups.
Five of the 12 patients who received VRDN-001 had diplopia and did not achieve complete resolution at week 6.
VRDN-001 was well tolerated, with no reported serious adverse events.