Immunovant Initiates Dosing in ASCEND-GO 1, a Phase 2a Trial of IMVT-1401 in Patients with Graves' Ophthalmopathy (GO)

NEW YORK and BASEL, Switzerland, May 23, 2019 /PRNewswire/ -- Immunovant, a clinical-stage biopharmaceutical company focused on developing innovative therapies for patients living with debilitating autoimmune diseases, today announced that it has initiated dosing in ASCEND-GO 1, an open label, single-arm Phase 2a clinical trial evaluating IMVT-1401 in patients with moderate-to-severe active Graves' ophthalmopathy (GO). IMVT-1401 is a novel, fully human monoclonal antibody that selectively binds and inhibits the neonatal Fc receptor (FcRn) and is designed to be delivered by subcutaneous injection.

In the ASCEND-GO 1 trial, an expected eight patients will receive six weekly subcutaneous injections of IMVT-1401: 680 mg for the first two administrations, followed by 340 mg for the final four administrations. The primary endpoints for this clinical trial are safety and tolerability. Changes from baseline in levels of anti-TSHR antibodies, total IgG antibodies and IgG antibody subclasses will also be measured. This trial has been designed without use of any intravenous induction dosing. Immunovant also expects to initiate ASCEND-GO 2, a randomized, dose-ranging Phase 2b clinical trial evaluating IMVT-1401 in patients with GO, later this quarter.

GO is a serious and disfiguring disease, potentially resulting in blindness. There are no FDA-approved therapies for GO today.

"We believe that IMVT-1401, by depleting the autoantibodies that cause Graves' ophthalmopathy, may offer a targeted treatment option for patients. In addition, IMVT-1401 is designed to be delivered in a convenient subcutaneous injection, avoiding the need for intravenous infusions. We look forward to gaining further insights from the Phase 2 ASCEND-GO program," said Sandeep C. Kulkarni, Chief Operating Officer of Immunovant.

For more information about this clinical trial, please visit www.clinicaltrials.gov. The clinicaltrials.gov identifier is NCT03922321.

About Graves' Ophthalmopathy

Graves' ophthalmopathy, also known as thyroid eye disease, is an autoimmune disorder that affects the muscles and other tissues around the eyes. GO has an estimated annual incidence of 16 per 100,000 women and 2.9 per 100,000 men in North America and Europe. Approximately one in 20 patients with Graves' disease will present with moderate-to-severe GO, which is characterized by swelling and redness of the eyelids, proptosis (protrusion of the eyeball), double vision, and, in severe cases, corneal ulceration and decreased visual acuity. GO is most commonly caused by IgG autoantibodies that form against the thyroid-stimulating hormone receptor (TSHR). These antibodies, which also cause Graves' disease, activate certain cell types, such as fibroblasts and adipocytes, that are present in the extraocular space, promoting inflammation and swelling that result in the clinical manifestations of the disease. There are no therapies approved by the Food and Drug Administration (FDA) for the treatment of GO.

About IMVT-1401

IMVT-1401 (formerly RVT-1401) is a novel, fully human monoclonal antibody being investigated for the treatment of IgG-mediated autoimmune diseases. IMVT-1401 is the product of a multi-step, multi-year research program, conducted by our collaboration partner, HanAll BioPharma, to design a highly specific anti-FcRn antibody optimized for delivery as a subcutaneous injection. These efforts have resulted in a product candidate that has been dosed at small volumes and with a small gauge needle. Immunovant intends to develop IMVT-1401 for debilitating autoimmune diseases in which there is robust evidence that pathogenic IgG antibodies drive disease manifestation and in which reduction of IgG antibodies should lead to clinical benefit. Immunovant has in-licensed the rights to develop, manufacture and commercialize IMVT-1401 in the United States, Canada, Mexico, the EU, the United Kingdom, Switzerland, the Middle East, North Africa and Latin America. In additional to GO, IMVT-1401 is also in Phase 2a clinical development for the treatment of myasthenia gravis.

About Immunovant

Immunovant, a member of the Roivant family of companies, is a clinical-stage biopharmaceutical company focused on developing innovative therapies that are designed to not only treat the symptoms, but also modify the course, of autoimmune disease. Immunovant's lead program is IMVT-1401, a novel, fully human anti-FcRn monoclonal antibody in development for the treatment of autoimmune diseases mediated by pathogenic IgG antibodies.

About Roivant Sciences

Roivant aims to improve health by rapidly delivering innovative medicines and technologies to patients. Roivant does this by building Vants – nimble, entrepreneurial biotech and healthcare technology companies with a unique approach to sourcing talent, aligning incentives, and deploying technology to drive greater efficiency in R&D and commercialization.

SOURCE Immunovant