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.
Phase I data show early efficacy in the majority of patients and a very favourable safety profile HASSELT, Belgium, and CHEPSTOW, UK, 16 April 2018 – Apitope, a clinical stage biotech company developing potential first-in-class antigen-specific immunotherapies targeting autoimmune diseases (including multiple sclerosis (MS), Graves’ disease and uveitis), today announced positive results from the Phase I first in man clinical trial of its product candidate, ATX-GD-59, in development for the treatment of Graves’ disease. Graves' disease is one of the most common autoimmune diseases with approximately 10 million patients across Europe and the US and yet there have been no innovative treatments in more than 60 years. With Graves’ disease, the immune system mistakenly attacks the thyroid gland and causes it to become overactive. Symptoms can include an enlargement of the thyroid gland, swelling of the neck, localised abnormalities of skin, tremors, heat intolerance and sweating, significant weight loss, osteoporosis, atrial fibrillation and ocular changes in patients. Each year 20-30 out of every 100,000 people are newly diagnosed with Graves' disease. The ratio of women versus men diagnosed with Graves' disease is 6:1 and around 2% of all women will develop Graves' disease during their lifetime. Dr Simon Pearce, Professor of Endocrinology, Newcastle University, and Chief Investigator for the trial commenting on the results said: “It is very exciting to see these promising Phase I results where ATX-GD-59 has shown both an encouraging safety and tolerability profile as well as efficacy. With current first-line treatments having a high failure rate, and the second-line treatments being either invasive surgery or radioiodine, ATX-GD-59 demonstrates the potential to address the high medical need for a new, safe and effective treatment for the neglected field of those suffering from Graves' disease.” The Phase I clinical study met the primary endpoint to assess the safety and tolerability of ATX-GD-59 in 12 patients with Graves’ disease. The majority of the per protocol subjects were either euthyroid, the clinical objective of therapy, or close to being euthyroid by the end of treatment; the effect was maintained during the 3 months follow up off therapy. Importantly, TSHR antibody levels were also reduced with close correlations between percentage decreases in antibody and thyroid hormone levels in line with the mechanism of action. Dr Keith Martin, Chief Executive Officer of Apitope, commented: “We’re highly encouraged by these data as they provide further evidence that our Apitope® platform identifies safe and effective treatments for autoimmune diseases. These findings are important for Graves’ disease patients in providing a potential new treatment paradigm aimed at the cause of the disease not just the symptoms. We will continue to progress the development of ATX-GD-59 as a treatment for Graves’ disease and are currently preparing to initiate a Phase II study in the first quarter of 2019.” The investigational product was administered intradermally (ID) every two weeks over a period of 18 weeks in male and female patients that were not otherwise being treated with anti-thyroid therapy. Following a titration period of 25, 50, 100, 400 and 800 μg in the initial eight weeks of treatment, a dose of 800 μg was administered fortnightly for an additional 10 weeks, comparable to the regime followed in the successful ATX-MS-1467 multiple sclerosis (MS) trials.
Apitope Announces Publication of Data in International Peer-Reviewed Journal Neurology on Novel Multiple Sclerosis Therapy
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