Bristol, UK and Hasselt, Belgium – 8 January 2014 − Apitope, the drug discovery and development company focused on treating the underlying cause of autoimmune diseases, today announces that the consortium, led by Apitope, which includes GSK Vaccines, Quintiles and KWS Biotest Limited, has been awarded prestigious Framework Programme 7 (FP7) Health Innovation funding by the European Commission to develop its Graves’ disease therapeutic vaccine, including a Phase I first-in-man study in Graves’ disease patients.
Graves’ disease is an immune system disorder that eventually results in the overproduction of thyroid hormones (hyperthyroidism). While a number of disorders may result in hyperthyroidism, Graves' disease is the most common cause affecting 2% of the female population. Symptoms of hyperthyroidism can include increased heart rate, muscle weakness, disturbed sleep, and irritability. Patients may also develop bulging eyes (proptosis). The disease affects multiple systems of the body, including the skin, heart, circulation and nervous system.
Apitope’s antigen-specific disease modifying peptide therapy uses epitopes designed to shut down the abnormal immune responses to the causative agent in a highly selective manner, re-instating the normal immune balance, thereby avoiding global immune suppression. As a result, the peptides taken into clinical evaluation by Apitope offer the potential to have limited side effects and a good probability of efficacy.
Dr. Keith Martin, CEO of Apitope stated: “Graves’ Disease is a disease with serious implications particularly for those with Graves’ orbitopathy who are at risk of blindness. Current treatments for this disease may result in abnormally low thyroid activity levels, requiring further medications, and do not treat the fundamental cause of Graves’ disease nor reduce the long term cardiac risks. This funding will allow a team of experts to develop a much needed therapy that may address the cause of this serious condition rather than simply treating the symptoms and removing the need for other medications.”
Professor Neil Williams, CSO of KWS BioTest said: “This is a really exciting approach to the treatment of an important human disease, which builds on the successes that Apitope has seen in its MS programme. We are looking forward to applying our expertise in the preclinical immunology and inflammation areas to help drive the project forwards into the clinic. The award of the EU grant helps to cement the close drug discovery partnership in the consortium.”
Notes To Editors
Apitope International NV, based in Belgium and the UK, is a world-class drug developer of immunotherapies for the treatment of autoimmune and allergic diseases, including multiple sclerosis, factor VIII intolerance, uveitis and Graves’ disease. The Company has a patented discovery platform which enables selection of disease-modifying peptide therapies for the autoimmune/allergic disease of interest; and has already generated a pipeline of seven programmes in clinical and preclinical development, of which the lead programme in multiple sclerosis is partnered with Merck Serono. The discovery engine selects Apitopes™ - Antigen Processing Independent epiTOPES. Apitopes are soluble, synthetic peptides from the human sequence which can selectively suppress abnormal immune responses and reinstate the normal immune balance. Stakeholders in the Company include the Wellcome Trust, LRM, Vesalius Biocapital and the US MS charity, Fast Forward. For more information on the Company, please visit: www.apitope.com
Quintiles will act in a comprehensive clinical trial services capacity for this Apitope-led Consortium. Quintiles (NYSE: Q) is the world’s largest provider of biopharmaceutical development and commercial outsourcing services with a network of more than 28,000 employees conducting business in approximately 100 countries. Quintiles has helped develop or commercialize all of the top-50 best-selling drugs on the market. Quintiles applies the breadth and depth of its service offerings along with extensive therapeutic, scientific and analytics expertise to help our customers navigate an increasingly complex healthcare environment as they seek to improve efficiency and effectiveness in the delivery of better healthcare outcomes. To learn more about Quintiles, please visit www.quintiles.com
About KWS Biotest
KWS BioTest Ltd is a UK based CRO specialising in offering preclinical services to pharmaceutical and biotechnology companies ranging from target validation, lead identification and candidate selection through to efficacy studies and PK/PD. The company specialises in inflammation, immunology and infection and works with its customers as a partner in discovery. Offering a wide range of validated assay models, but also being able to develop new systems that suit the needs of specific projects enables KWS to act be a truly flexible service provider. For more information on the company visit: www.kwsbiotest.com
About Graves’ disease
Graves’ disease (GD) is an autoimmune disorder caused by auto-reactive T and B lymphocytes targeting the primary auto-antigen, the Thyroid Stimulating Hormone Receptor (TSHR).
TSHR is a G-protein-coupled receptor on thyroid follicular cells in the thyroid gland that stimulates the production of thyroxine (T4) and triiodothyronine (T3) via a cAMP signal cascade upon binding of its ligand, the thyroid-stimulating hormone. Upon internalization, degradation and presentation of the TSHR by APCs, T cells become activated and interact with auto reactive B cells, which in turn produce stimulating agonistic auto-antibodies directed against this receptor. The thyroid-stimulating immunoglobulins bind to the same receptor pocket as the thyroid-stimulating hormone, activating the TSHR mediated signal transduction and leading to the production of excess thyroid hormone from the thyroid gland and thyroid growth.
An overactive thyroid gland can be related with hyperthyroid symptoms such as increased heart rate, muscle weakness, disturbed sleep, and irritability. It can also affect the eyes, causing bulging eyes (proptosis). It affects multiple systems of the body, including the skin, heart, circulation and nervous system.
There is a strong hereditary component linked to GD; when one identical twin has Graves' disease, the other twin will have it 25% of the time. It affects up to 2% of the female population, sometimes appears after childbirth, and is five to ten times as common in women as in men.
Issued for and on behalf of Apitope.
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Melanie Toyne-SewellManaging Partner