A Treatment for Graves’ Disease Produced Promising Results in a Phase 1 Trial

 

A biotechnology company called Apitope is developing an innovative new immunotherapy treatment for a range of autoimmune diseases. A press release by the company that can be found here gave an update on a phase 1 trial of the treatment in patients with Graves’ disease and showed encouraging results.

Graves’ disease is an autoimmune disease that causes over-activation of the thyroid gland. The thyroid gland is located in the neck and secretes two hormones into the blood that influence the metabolism rate, or how fast your cells work. In people with Graves’ disease the over-activation of the thyroid causes cells to work more quickly than they would normally do. Since the thyroid gland affects many metabolic processes in the body the symptoms of Graves’ disease can also be broad and depend on the particular ways in which the thyroid and body respond in each patient.

Some of symptoms include weight loss, anxiety, fatigue, patches of thick red skin (known as Graves’ dermopathy), and heat sensitivity. Graves’s disease is also associated with a condition called Graves’ ophthalmopathy that affects ~30% of patients. It is caused by an immune system reaction around the eyes that results in bulging eyes, eye pain, double vision or vision loss, and light sensitivity, amongst others. Graves’ disease is more likely to occur in those under 40 and about six times more frequent in women, although it can affect anyone. It is has one of the highest incidence rates of any autoimmune disease and affects approximately 10 million people throughout the US and Europe.

Graves’ disease is usually treated using anti-thyroid drugs and beta-blockers, however, these do not work for some patients. Failing these, the second line of treatment tends to be surgery or radioactive iodine therapy, both of which have severe side effects. The treatment options for patients are therefore limited and there has been little innovation over the last six decades.

The new immunotherapy medicine being tested by Apitope would provide a significant development in the treatment of this disease. The medicine, called ATX-GD-59, was tested in a phase 1 clinical trial on twelve patients with Graves’ disease. It was administered through an injection every two weeks for a total of eighteen weeks. By the end of the study, all patients either had a normally functioning thyroid gland or were close to achieving that. This remained the case during the three months of follow up after the end of the study. Furthermore, TSHR antibody levels were shown to have decreased in patients who received the therapy. TSHR antibodies stimulate the thyroid gland to cause Graves’ disease, so a reduction in their number shows that the treatment addressed the underlying cause of the disease rather than just the symptoms.
Apitope’s immunotherapy treatment shows significant potential for improving the symptoms of Graves’ disease in patients. Based on these encouraging results, the company is planning to launch a phase II trial of the drug early next year. Research into its use in other autoimmune diseases, including uveitis and multiple sclerosis, is on-going.

Anna Hewitt

Anna Hewitt

Anna is from England and recently finished her undergraduate degree. She has an interest in medicine and enjoys writing. In her spare time she likes to cook, hike, and hang out with cats.

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