Positive Phase 2a Study Results Announced for Thyroid Eye Disease Treatment
A thyroid eye disease treatment candidate showed a 65% improvement in IgG levels in a phase 2a proof-of-concept study, according to a press release by Immunovant, Inc.
IMVT-1401, a novel investigational anti-FcRn antibody, was tested in a multi-center, open-label, single-arm clinical trial of 7 patients with moderate-to-severe active thyroid eye disease. Patients received 2 weekly 680 mg subcutaneous doses of IMVT-1401 followed by 4 weekly 340 mg subcutaneous doses of IMVT-1401. All patients have completed treatment and are now in the follow-up phase of the trial.
At the end of treatment, there was a mean reduction of 65% in total IgG levels from baseline and 57% of patients improved Clinical Activity Score by ≥ 2 points. There was a 67% (4/6 patients) demonstrated improvement in diplopia.
“These results provide an early proof of concept of the potential for IMVT-1401 to ultimately become a safe and effective treatment for patients suffering from thyroid eye disease. Importantly, IMVT-1401 was delivered by subcutaneous injection, opening the possibility of at-home treatment rather than infusion center-based treatment, for patients with Thyroid Eye Disease. We look forward to reporting the study’s full results, including detailed lab observations and 12 weeks of follow up data, at an upcoming medical meeting,” said Pete Salzmann, MD, CEO of Immunovant, in the release.