Veligrotug for treatment of thyroid eye disease meets endpoints in phase 3 trial
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Viridian Therapeutics reported positive topline data from the phase 3 THRIVE clinical trial of veligrotug for the treatment of active thyroid eye disease.
The intravenously delivered anti-insulin-like growth factor-1 receptor antibody, formerly known as VRDN-001, achieved all primary and secondary endpoints, according to a press release. Patients treated with five infusions showed statistically significant improvement in measured signs and symptoms of thyroid eye disease (TED) at 15 weeks.
Patients treated with veligrotug had a proptosis responder rate of 70% compared with 5% in those who received placebo. Additionally, 54% of those who received veligrotug had complete resolution of diplopia compared with 12% in the placebo group, with an overall responder rate of 67% compared with 5%, respectively.
Veligrotug was well tolerated, the majority of adverse events were mild, and there was a low discontinuation rate.
Viridian anticipates that veligrotug will be ready for submission of a biologics license application in the second half of 2025.
“Our excitement with the THRIVE results extends well beyond veligrotug to the other half of our clinical TED franchise, subcutaneously administered VRDN-003, for which we initiated two phase 3 clinical trials last month. We believe veligrotug and VRDN-003 have the potential to become the preferred treatments for TED patients,” Viridian president and CEO Steve Mahoney said in the release.
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