All endpoints achieved in phase 3 trial of chronic thyroid eye disease treatment

Key takeaways:

• Veligrotug for chronic thyroid eye disease yielded improvements in proptosis, clinical activity scores and diplopia.
• Viridian plans to submit a biologics license application for veligrotug in 2025.

A phase 3 clinical trial of veligrotug, an anti-insulin-like growth factor-1 receptor antibody, met primary and secondary endpoints involving proptosis, clinical activity scores and diplopia for the treatment of chronic thyroid eye disease.

According to a press release from Viridian Therapeutics, 188 patients with chronic thyroid eye disease were randomly assigned to receive veligrotug (125 patients) or placebo (63 patients) in the THRIVE-2 trial. Participants received five infusions of veligrotug, and endpoints were assessed at 15 weeks.

The proptosis responder rate, defined as at least a 2 mm reduction in proptosis from baseline in the study eye without worsening of more than 2 mm in the fellow eye, was 56% in patients who received veligrotug vs. 8% in patients who received placebo (48% placebo-adjusted, P < .0001). The mean reduction in proptosis from baseline was 2.34 mm with veligrotug vs. 0.46 mm with placebo (1.9 mm placebo-adjusted, P < .0001).

Fifty-six percent of patients who received veligrotug achieved a diplopia response, defined as a reduction of at least 1 on the Gorman subjective diplopia scale at week 15, compared with 25% of patients who received placebo (31% placebo-adjusted, P = .0006). Thirty-two percent of patients who received veligrotug achieved complete resolution of diplopia compared with 14% of patients who received placebo (18% placebo-adjusted, P = .0152).

Improvements in clinical activity scores (CAS) were also statistically significant, with 54% of patients who received veligrotug achieving “maximal or near-maximal therapeutic effect” on CAS compared with 24% of patients who received placebo (29% placebo-adjusted, P = .006).

Fifty-six percent of patients who received veligrotug achieved an overall response, defined as a proptosis response without worsening of CAS from baseline and without worsening in proptosis or CAS in the fellow eye, compared with 7% of patients who received placebo (50% placebo-adjusted, P < .0001).

Overall, veligrotug was well tolerated, with 94% of patients completing the treatment course, and the majority of adverse events were mild. There was a 9.6% placebo-adjusted rate of hearing impairment (12.8% incidence with veligrotug vs. 3.2% incidence with placebo).

Viridian said it is on track to submit a biologics license application for veligrotug in the second half of 2025.

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