Low dose of thyroid eye disease treatment promising in phase 1/2 trial
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VRDN-001 demonstrated positive results at a low dose for the treatment of active thyroid eye disease in a phase 1/2 clinical trial, according to a press release from Viridian Therapeutics.
The ongoing trial investigated two intravenous infusions of VRDN-001, an anti-insulin-like growth factor 1 receptor antibody, administered 3 weeks apart, at doses of 3 mg/kg, 10 mg/kg and 20 mg/kg. Each cohort included six participants randomly assigned to VRDN-001 and two participants randomly assigned to placebo. Efficacy was measured 6 weeks after the first dose. Positive results were previously reported for the 10 mg/kg and 20 mg/kg cohorts.
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The 3 mg/kg cohort showed a positive proptosis responder rate of 67% (71% across all groups), with a mean reduction in proptosis of 2.7 mm (2.3 mm across all groups) as measured by exophthalmometry. There was a mean reduction in clinical activity score from baseline in the 3 mg/kg cohort of 4.2 points (4.1 points across all groups) and a maximal or near-maximal therapeutic effect on the score of 67% (62% across all groups).
VRDN-001 was well tolerated across all cohorts and resulted in no serious adverse events, discontinuations or infusion reactions.
“The rapid and meaningful improvements in signs and symptoms of TED observed with a low dose of VRDN-001 reinforce previously reported findings in this trial and suggest that VRDN-001 may offer a differentiated efficacy profile,” trial investigator Roger Turbin, MD, a professor of ophthalmology and visual science in the department of ophthalmology, Rutgers New Jersey Medical School, said in the release. “The data also support development of VRDN-001 as a patient-friendly low-volume subcutaneous injection, which could reduce the burden of care for patients suffering from TED.”
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