Date: 2016-10-26
Type of information: Treatment of the first patient
phase: 1
Announcement: treatment of the first patient
Company: Apitope (UK - Belgium)
Product: ATX-GD-459
Action
mechanism: 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.
Disease: Graves' disease
Therapeutic area: Autoimmune diseases
Country:
Trial details:
Latest
news: * On October 26, 2016, Apitope announced 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. The 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, is the chief investigator for the trial. He 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.” 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. * On June 19, 2014, Apitope announced that it has started preclinical development of its novel peptide therapy ATX-GD-459 for the treatment of Graves' disease. Apitope, through its innovative discovery platform, has selected three peptides in ATX-GD-459 that have the potential to treat and prevent the production of stimulating antibodies against TSHR (thyroid stimulating hormone receptor) that lead to Graves' disease. The disease is linked to the thyroid gland and the overproduction of the thyroid hormones thyroxine (T4) and triiodothyronine (T3). The overproduction of thyroid hormones is caused by auto-reactive T and B lymphocytes targeting the primary auto-antigen, TSHR. This activation of the thyroid cells through the auto-antibodies results in the typical Graves' disease hyperthyroidism and respective symptoms. The development of ATX-GD-459 is part of the DAVIAD project co-financed by the European Commission in the 7th Framework Programme, FP7-HEALTH-2013-INNOVATION-1, 602779. The DAVIAD consortium is comprised of Apitope as coordinator, GlaxoSmithKline Biologicals SA, Quintiles Benefit and KWS Biotest Limited.
