HASSELT, Belgium, and CHEPSTOW, UK, 19 March 2018 – Apitope, a clinical stage biotech company developing potential first-in-class antigen-specific immunotherapies targeting autoimmune diseases, today announced publication of data on it multiple sclerosis treatment in Neurology, the official journal of the American Academy of Neurology and one of the world’s most widely read and highly cited peer-reviewed neurology medical journals.
The publication entitled: Effects of ATX-MS-1467 immunotherapy over 16 weeks in relapsing multiple sclerosis1 , outlines results from two clinical studies to assess the safety, tolerability and efficacy of Apitope’s antigen-specific immunotherapy, ATX-MS-1467, in patients with relapsing multiple sclerosis.
The two open-label trials reported in the paper were conducted in patients with relapsing multiple sclerosis using different treatment protocols to induce tolerance. Both studies demonstrated an highly favourable safety profile with zero treatment related serious adverse events and showed a significant decrease in both new lesions and lesion volume, as well as a significant improvement in cognition. No changes in EDSS and MSFC scores from baseline to the end of treatment were observed although there was a strong trend for improvement in MSFC (p=0.054). The paper concluded that relatively slow ATX-MS-1467 titration and a longer full-dose intra-dermal treatment period is associated with reduction in gadolinium enhancing lesions and a sustained effect post-treatment and that further trials of ATX-MS-1467 are warranted.
Keith Martin, CEO of Apitope, said: “We are delighted that these data have been published in Neurology, a premier peer-reviewed journal for clinical neurologists. ATX-MS-1467 is the first potential therapeutic for multiple sclerosis that has the potential to combine high efficacy with an excellent, and thereby differentiating, safety profile.”
Dr Jeremy Chataway, Lead author and Consultant Neurologist National Hospital for Neurology and Neurosurgery and Reader in Neurology, University College London, said: “Apitope’s antigen-specific immunotherapy approach, to reinstate tolerance to the protein causing the disease, represents a major conceptual shift away from most current and emerging immunomodulatory therapies for multiple sclerosis. The results from a phase 1b and phase 2a study outlined in the Neurology publication, further support ATX-MS-1467 as a potentially effective and well-tolerated new therapy.”
1 Neurology. 2018 Mar 13;90(11):e955-e962. doi: 10.1212/WNL.0000000000005118. Epub 2018 Feb