Apitope starts preclinical development of ATX-GD-459 for Graves' disease treatment

Initiates Preclinical Development of Peptide Therapy

Apitope, the drug discovery and development company focused on disease-modifying treatments for patients with autoimmune and allergic diseases, announced today 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.

Graves' disease is an autoimmune disorder that impacts over 7.5 Million people worldwide. Patients with Graves' disease typically develop goitre and serious medical issues such as increased heart rate, muscle weakness, disturbed sleep, and irritability. It affects multiple systems of the body, including the skin, heart, circulation and nervous system with potential long term morbidity. Some 30-50% of Graves' disease patients develop the medically challenging Graves' orbitopathy characterised by bulging eyes (proptosis), while 3-5% of such patients suffer from a sight-threatening form of Graves' orbitopathy.

Graves' 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.

Dr. Keith Martin, CEO of Apitope said: "Apitope is developing innovative products based on therapeutic peptides to treat a range of life-threatening autoimmune and allergic diseases, including rare conditions. We are delighted to progress the development of these innovative peptides which have the potential to help Graves' disease patients. We now have seven programmes in clinical, and preclinical development and discovery as we continue to maximise the potential of our innovative discovery platform."

The development of ATX-GD-459 is part of the DAVIAD project (http://www.daviad.eu) 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.

Prof David Wraith, CSO and Founder of Apitope, added, "Bringing this latest product through into preclinical development is another important milestone event for Apitope and provides further evidence that our discovery platform can generate new potentially life changing therapies for development and validates further the scientific basis of our approach."