Full Press Release Details
Immunovant Initiates Dosing
in ASCEND-GO 2, a Phase 2b Trial of IMVT-1401 in Patients with Graves' Ophthalmopathy (GO)
YORK and BASEL, Switzerland, November 25, 2019 /PRNewswire/ - 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.
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:
more information about the ASCEND-GO 2 trial, please visit www.clinicaltrials.gov. The clinicaltrials.gov identifier
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.
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.
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.
Important Notice Regarding Forward-Looking Statements
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that are not historical facts, including statements about the initiation, timing, progress, reporting of results of Immunovant's
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Pam Connealy, M.B.A.
Chief Financial Officer