Apitope Announces Enrolment of First Patient in Phase I Trial of ATX-GD-59 for the Treatment of Graves’ Disease

Hasselt, Belgium and Chepstow, UK: 26th October 2016 − Apitope, the drug discovery and development company focused on treating the underlying cause of autoimmune diseases, today announces that the first patient has been enrolled in the Phase I clinical trial of its novel peptide therapy, ATX-GD-59, for the treatment of Graves’ disease.

Apitope’s ATX-GD-59 has the potential to treat and prevent the production of stimulating antibodies against TSHR (thyroid stimulating hormone receptor) that lead to Graves’ disease. The Phase I trial will recruit up to 30 patients and is designed to assess the safety and initial efficacy of the product.

Dr Simon Pearce, Professor of Endocrinology, Newcastle University, and Chief Investigator for the trial commented: “This is the first new therapy for Graves’ disease to be tested in over 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.”

Dr Keith Martin, CEO of Apitope, said: “Graves’ disease is an autoimmune disorder that impacts over 5 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 which have the potential to treat Graves’ disease patients.”

Graves’ Disease is the most common auto-immune disorder with prevalence rates of approximately 0.2% in Europe and 0.5% in the US (>2.4 million in EU and 2.6 million in the US); far outreaching the numbers of rheumatoid arthritis or type 1 diabetes patients. It 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) caused by auto-antibodies. It can lead to high risk of long-term cardiovascular morbidity and mortality.

About 30-50% of patients also suffer from Graves’ orbitopathy characterized by a protrusion of one or both eyes caused by the auto-antibody driven inflammation in extraocular eye muscles, connective and adipose tissue. Without treatment, it can lead to visual impairments and even blindness in a significant proportion (3-5%) of patients. It is therefore considered as a serious unmet need confirmed by The European Group on Graves’ orbitopathy (EUGOGO). Paediatric Graves’ disease is also recognised as an important unmet need with low levels of response.

Approximately 50% of patients fail the current first line therapy. This provides a real opportunity for Apitope’s immunotherapy. In particular, early intervention may prevent moderate-to-severe or sight- threatening Graves’ orbitopathy from occurring or significantly ameliorate the symptoms without the need to suppress the whole immune system. This would greatly improve the health-related quality of life of the patients.