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

  • IMVT-1401, a fully human anti-FcRn antibody designed to be administered via subcutaneous injection, is the only anti-FcRn antibody known to be in clinical development for the treatment of GO
  • Topline results from the ASCEND-GO 2 program are expected in early 2021
  • IMVT-1401 is also being evaluated in ASCEND-MG, an ongoing Phase 2a trial for the treatment of myasthenia gravis, and ASCEND-GO 1, an open-label Phase 2a trial for the treatment of GO

NEW YORK, NY, USA and BASEL, Switzerland I November 25, 2019 I Immunovant, a clinical-stage biopharmaceutical company focused on enabling normal lives for patients with autoimmune diseases, today announced that it has initiated dosing in ASCEND-GO 2, a multicenter, randomized, masked, placebo-controlled Phase 2b clinical trial evaluating IMVT-1401 in patients with moderate-to-severe active Graves’ ophthalmopathy (GO). IMVT-1401 is a fully human monoclonal antibody that selectively binds to and inhibits the neonatal Fc receptor (FcRn) and is designed to be delivered by subcutaneous injection.

In the ASCEND-GO 2 trial, 77 patients are expected to receive twelve weekly subcutaneous injections of 680 mg, 340 mg or 255 mg IMVT-1401 or placebo. The primary endpoints of this trial are the proptosis responder rate measured at week 13, defined as the percentage of patients with a > 2 mm reduction in proptosis in the study eye without deterioration in the fellow eye, and safety and tolerability. Secondary endpoints include the proptosis responder rate at various timepoints, Clinical Activity Score (CAS) responder rate, mean change from baseline in proptosis, CAS, diplopia, quality-of-life measures, and pharmacokinetics/pharmacodynamics. This trial has been designed without the use of any intravenous induction dosing and does not require dosing at infusion centers. Topline results from this trial are expected in early 2021.

“Graves’ ophthalmopathy can be a devastating and sight-threatening disease with a dramatic impact on patients’ vision and overall well-being. There is an urgent need for more effective and better tolerated treatment options which can be easily administered by physicians or patients. By depleting the autoantibodies responsible for this condition, IMVT-1401 has the potential to become a foundational therapy for GO and offer patients a convenient subcutaneously-administered treatment option to control their disease,” said Dr. Pete Salzmann, CEO of Immunovant.

Immunovant reiterates its previous guidance regarding data releases from the other ongoing and planned Phase 2 clinical trials:

  • Initial results from ASCEND-GO 1, an open-label Phase 2a clinical trial of IMVT-1401 for the treatment of GO, are expected in Q1 2020.
  • Topline results from ASCEND-MG, an ongoing Phase 2a clinical trial of IMVT-1401 for the treatment of myasthenia gravis, are expected in the 1H 2020.
  • Initial results from a Phase 2a clinical trial of IMVT-1401 for the treatment of warm autoimmune hemolytic anemia are expected in Q4 2020.

For more information about the ASCEND-GO 2 trial, please visit www.clinicaltrials.gov. The clinicaltrials.gov identifier is NCT03938545.

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), diplopia (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 U.S. Food and Drug Administration (FDA) for the treatment of GO.

About Immunovant

Immunovant, a member of the Roivant family of companies, is a clinical-stage biopharmaceutical company focused on enabling normal lives for patients with autoimmune diseases. Immunovant is developing IMVT-1401, a novel, fully human anti-FcRn monoclonal antibody, as a subcutaneous injection for the treatment of autoimmune diseases mediated by pathogenic IgG antibodies.

On October 2, 2019, Immunovant announced its plan to merge with Health Sciences Acquisitions Corporation (HSAC), a special purpose acquisition company sponsored by RTW Investments. For further information about Immunovant, please visit www.immunovant.com.

SOURCE: Immunovant

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