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Apitope Regains Global Rights to its Novel Treatment for Multiple Sclerosis From Merck KGaA, Darmstadt, Germany

Monday, October 17, 2016 General News J E 4
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CHEPSTOW, Wales and HASSELT, Belgium, October 17, 2016 /PRNewswire/ --

Apitope is a drug discovery and development company focused on highly selective therapies that reinstate immune tolerance and thereby treat the underlying cause of autoimmune, as well as allergic diseases. Today Apitope announces it has regained global rights to its compound, ATX-MS-1467, a potentially disease-modifying therapy for the treatment of Multiple Sclerosis (MS). Under the agreement with Merck KGaA, Darmstadt, Germany, Apitope will regain all rights and clinical data associated with its compound ATX-MS-1467, which just completed a Phase II clinical trial.

Dr Keith Martin, CEO of Apitope, commented: "We believe ATX-MS-1467 has enormous potential for treating MS patients. We are pleased to be regaining the rights to the compound, as well as the clinical data. This will provide us with greater flexibility and control in the clinical development of ATX-MS-1467. We are now able to pursue new business collaborations to enable the further development of this promising treatment. We appreciate the efforts made by the Merck KGaA, Darmstadt, Germany - team members in advancing this programme to date."

ATX-MS-1467 has successfully completed a Phase I clinical trial in six patients with secondary progressive MS (SPMS) and a second Phase I trial in 43 relapsing MS patients, assessing safety as well as biological parameters. Examination of the MRI results (new gadolinium- and total gadolinium-enhancing [Gd+] lesions) demonstrated a decrease of 78% in the number of Gd+ brain lesions in patients with relapsing MS treated with intradermal injection of ATX-MS-1467.

In 2009, Apitope granted exclusive worldwide rights to Merck KGaA, Darmstadt, Germany to develop and commercialize ATX-MS-1467. Enrolment in a Phase IIa clinical trial of ATX-MS-1467 in Relapsing Multiple Sclerosis was completed in mid-2015, and the outcome of the study is expected Q4 2016.

The terms of the agreement are not disclosed.

-ENDS-

For further information: Apitope Dr Keith Martin, CEO +44 117 370 7720 keith.martin@apitope.com Hume Brophy Mary Clark, Supriya Mathur and Alexia Faure Tel: +44 (0)20 7862 6381 apitope@humebrophy.com

About Apitope Apitope is a European biotech company focused on the discovery and development of revolutionary disease modifying therapies for autoimmune and allergic diseases and anti-drug antibodies, including multiple sclerosis, Graves' disease, Factor VIII intolerance and uveitis. The Company has a patented discovery platform which enables selection of disease-modifying peptide therapies; and has already generated a pipeline of seven programmes in clinical and preclinical development, of which the lead programme is in multiple sclerosis. 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. Apitope raised €12 million in a Series B financing in September 2015. The round was led by new investor Wales Life Sciences Fund. Stakeholders in the Company include Wales Life Sciences Fund, the Wellcome Trust, LRM, Vesalius Biocapital and the US MS charity, Fast Forward. For more information on the Company, please visit: www.apitope.com About ATX-MS-1467 Apitope's lead product candidate is ATX-MS-1467, a potentially disease-modifying therapy for the treatment of MS. ATX-MS-1467 is a novel peptide-based therapeutic derived from Apitope's proprietary technology platform. It is designed to target up to 70% of patients with MS who have a specific genetic profile. It consists of four short peptides that are derived from myelin basic protein, a key autoantigen in MS. It is designed to induce immunological tolerance of the body's T cells to key autoantigens thought to be involved in the pathogenesis of MS.

SOURCE Apitope International NV

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