RARE Daily

Immunovant Reports Proof-of-Concept of Its Therapy for Thyroid Eye Disease

March 30, 2020

Rare Daily Staff

Immunovant reported initial results from the treatment phase of its ongoing phase 2a study of IMVT-1401 in patients with thyroid eye disease, also known as Graves’ ophthalmopathy.

Thyroid eye disease (TED) is a rare disease that most commonly occurs as part of Graves’ disease, an autoimmune disease that affects the thyroid and often the skin and eyes. It is characterized by progressive inflammation and damage to tissues around the eyes, especially extra-ocular muscle, connective, and fatty tissue, with an active disease phase in which progressive inflammation, swelling, and tissue changes occur. The active phase is followed by an inactive phase in which the disease progression has stopped, but some symptoms such as double vision and bulging eyes can remain. Although uncommon, in severe instances, vision loss can occur.

Immunovant’s IMVT-1401 is a novel, fully human anti-FcRn monoclonal antibody, being developed as a subcutaneous injection for the treatment of autoimmune diseases mediated by pathogenic IgG antibodies. The multi-center, open-label, single-arm clinical trial evaluated two weekly 680mg subcutaneous doses of IMVT-1401 followed by four weekly 340mg subcutaneous doses of IMVT-1401 in seven adult patients with moderate-to-severe active TED. All patients in the trial have completed IMVT-1401 treatment and have entered the follow-up phase of the trial.

Mean reduction in total IgG levels from baseline to end of treatment was 65 percent. By the end of treatment, four patients (57 percent) improved by more than 2 points on the Clinical Activity Score, and three patients (43 percent) responded to less protrusion of the eye. IMVT-1401 was safe and generally well-tolerated with no serious adverse events, no withdrawals due to adverse events, and no headaches. The results establish the first proof of concept for an anti-FCRn antibody in TED.

“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,” said Pete Salzmann, CEO of Immunovant. “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.

Immunovant will report the study’s full results, including detailed lab observations and 12 weeks of follow up data, at an upcoming medical meeting.

Photo: Pete Salzmann, CEO of Immunovant

Stay Connected

Sign up for updates straight to your inbox.