Patient Dosing Begins in Graves’ Ophthalmopathy Clinical Trial

According to a story from tmcnet.com, the biopharmaceutical company Immunovant has just announced that beginning of patient dosing in its phase 2b clinical trial. This clinical trial will test the company’s investigational drug candidate IMVT-1401 as a treatment for Graves’ ophthalmopathy that is moderate to severe. Immunovant is dedicated to the development of treatments for autoimmune diseases.

About Graves’ Ophthalmopathy

Graves’ ophthalmopathy, which is also called thyroid eye disease, is a rare, inflammatory disorder that affects the orbital and periorbital tissues around the eye. People with this condition often have eyes that are abnormally bulged in appearance. It is an autoimmune disease, meaning that it is triggered by an abnormal immune response in which the system mistakenly attacks healthy tissue. While most common in people with Graves’ disease, the condition can appear alongside a variety of conditions that affect the thyroid. Women are more likely to be affected than men. Symptoms include conjunctivitis, retracted upper eyelids, swelling, eye redness, lid lag, and bulging eyes. Though some cases are mild and resolve on their own, more serious cases constitute a medical emergency due to compression of the optic nerve and should be treated promptly. Treatment includes steroids and other medication to bring down inflammation, surgery, and medications to regulate thyroid hormones. To learn more about Graves’ ophthalmopathy, click here.

About The Clinical Trial

IMVT-1401 is developed as a monoclonal antibody that is an inhibitor of the neonatal Fc receptor (FcRn). The clinical trial includes a total of 77 patients that will receive varying dose levels of the drug on a weekly basis for twelve weeks. The main endpoint in this trial is the percentage of patients with a reduction in proptosis (eye bulging) of at least 2 mm by week 13 without deterioration in the untreated eye. Secondary endpoints will monitor proptosis reduction at several different times during the study, as well as clinical activity score (CAS) responder rate and various quality of life measures.

The goal of treatment with IMVT-1401 is the depletion of autoantibodies associated with Graves’ ophthalmopathy. This condition, when untreated, can be threatening to a patient’s sight ability and overall quality of life. Positive findings in this trial would put IMVT-1401 in position to be a new standard therapy for the illness.


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