Apitope is a clinical stage biotech company developing potential first-in-class antigen-specific immunotherapeutics targeting the immunological basis of autoimmune diseases.
We use our novel, proprietary discovery platform to select and develop highly specific peptide-based therapies, known as “apitopes®”, which restore the natural balance of the immune system. This mechanism of action avoids global immune suppression and has the broad potential to treat a wide variety of autoimmune diseases.
We have developed a robust pipeline of innovative, potential first-in-class product candidates in clinical and pre-clinical development, thereby focussing on autoimmune diseases with significant unmet medical need.
Hasselt, Belgium and Chepstow, UK: 21 February 2017 − Apitope, the drug discovery and development company focused on treating the underlying cause of autoimmune diseases, announces positive results from the Phase IIa clinical study of its lead product candidate, ATX-MS-1467, for the treatment of patients with multiple sclerosis. The Phase IIa, open-label, one arm study evaluated the effects of ATX-MS-1467 in 19 patients with relapsing multiple sclerosis. The investigational product was administered intradermally (ID) every 2 weeks for 20 weeks. Following a dose titration of 50 and 200 μg in the initial 4 weeks of treatment a dose of 800μg was administered fortnightly for a further of 16 weeks. There were statistically significant reductions in total and new T1 Gadolinium enhancing lesions measured using MRI during treatment as well as a significant reduction in the volume of T1 Gadolinium enhancing lesions. The data also showed a strong trend towards improvement in the Multiple Sclerosis Functional Composite (MSFC) score that is used clinically as an indicator of improvement in disability. There were no treatment related serious adverse events and the adverse event profile was mild. Dr Keith Martin, Chief Executive Officer of Apitope, commented: “We are delighted with these positive results that confirm both clinical findings in our Phase Ib trial as well as preclinical results showing significant decreases in MRI detected lesions and disability in a standard multiple sclerosis model. We will continue to progress the development of ATX-MS-1467 as a treatment for multiple sclerosis and are currently preparing for a Phase IIb placebo controlled study to demonstrate clinical efficacy.” Dr Jeremy Chataway, Consultant Neurologist, National Hospital for Neurology and Neurosurgery, London, commenting on the results said: “Having been the Chief Investigator on the previous Phase Ib study, it is pleasing to see these promising confirmatory Phase IIa results where ATX-MS-1467 has shown both an encouraging efficacy and an excellent safety and tolerability profile. While these patients were only treated for 20 weeks, results in a Phase IIb study with a longer treatment period will be interesting.” The compound had previously completed a Phase I clinical study in six patients with secondary progressive multiple sclerosis (SPMS) and a second Phase I study in 43 relapsing multiple sclerosis patients, assessing safety and biological parameters. The latest results support the further development of ATX-MS-1467 in multiple sclerosis.
Hasselt, Belgium and Chepstow, UK: 15 November 2016 − Apitope, the clinical stage company focused on treating the underlying cause of autoimmune diseases, is pleased to announce that Apitope is featured in the 60 Years of Immunology report by the British Society for Immunology (BSI). In the report, Professor David Wraith, Founder & Chief Scientific Officer of Apitope, discusses the importance of moving away from non-specific immunosuppressive drugs that make patients susceptible to infections as well as cancers and instead help the immune system correct itself using antigen specific immunotherapy. The BSI is one of Europe’s largest and oldest societies and is dedicated to supporting immunology and immunologists. It was founded 60 years ago in 1956 by a small group of hard working, visionary immunologists, who wanted to come together to share ideas and encourage the study of immunology. With over 3,000 members, the society’s mission is to promote excellence in immunological research, scholarship and clinical practice in order to improve human and animal health. The BSI publishes the journals, Immunology and Clinical & Experimental Immunology. Dr Keith Martin, CEO of Apitope, commented: “It is a great honour to be included the BSI’s report highlighting the key advances in immunology including the use of antigen specific therapy pioneered by our CSO, Professor David Wraith, to celebrate the Society’s 60 years. Apitope has built an exciting portfolio of product candidates with two programmes in the clinic; one for multiple sclerosis and another for Graves’ disease whilst a peptide therapy for Factor VIII inhibitor patients is being prepared for initiation of clinical trials. We have a pipeline of seven programmes in clinical and preclinical development for the treatment of multiple sclerosis, Graves’ disease, Factor VIII intolerance and uveitis. These have the potential to be uniquely disease-modifying therapies.”