Apitope, a drug discovery and development company, has enrolled the first patient in the Phase I clinical trial of its peptide therapy, ATX-GD-59, to treat Graves’ disease.
Apitope’s ATX-GD-59 has the potential to treat and prevent the generation of stimulating antibodies against TSHR (thyroid stimulating hormone receptor) that lead to Graves’ disease.
The Phase I study will enrol up to 30 patients and is intended to analyse the safety and initial efficacy of the product.
Newcastle University endocrinology professor and chief investigator of the trial Dr Simon Pearce said: “This is the first new therapy for Graves’ disease to be tested in more than 50 years and is a significant step forward in the development of the drug.
"We are very pleased to be leading the first clinical trial of ATX-GD-59, which has significant potential to treat the underlying cause of this condition for the first time.”
Apitope CEO Dr Keith Martin said: “Graves’ disease is an autoimmune disorder that impacts more than five million people worldwide. There is no cure and the current treatment options available for patients have limited efficacy.
"Apitope is developing innovative products based on therapeutic peptides to treat a range of life-threatening autoimmune diseases, including rare conditions. We are delighted to progress the development of these innovative peptides that have the potential to treat Graves’ disease patients.”
Graves’ disease is a common auto-immune disorder with prevalence rates of approximately 0.2% in Europe and 0.5% in the US, far outreaching the numbers of rheumatoid arthritis or type 1 diabetes patients.
Furthermore, this problem is more common in women than men.
This autoimmune endocrine disorder is linked to the thyroid gland and the overproduction of the thyroid hormones thyroxine (T4) and triiodothyronine (T3) that are caused by auto-antibodies. It can lead to high risk of long-term cardiovascular morbidity and mortality.
Approximately 30% to 50% of patients also suffer from Graves’ orbitopathy, which is characterised by a protrusion of one or both eyes caused by the auto-antibody driven inflammation in extraocular eye muscles, connective and adipose tissue.
Unless treated, it can lead to visual impairments and even blindness in 3% to 5% of patients. Around 50% of patients fail the current first line therapy and this offers a real opportunity for Apitope’s immunotherapy.
Image: Bulging eye is one of the symptoms of Grave’s disease. Photo: courtesy of Jonathan Trobe/Wikipedia.