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.”
Apitope Announces Enrolment of First Patient in Phase I Trial of ATX-GD-59 for the Treatment of Graves’ Disease
Hasselt, Belgium and Chepstow, UK: 26th October 2016 − Apitope, the drug discovery and development company focused on treating the underlying cause of autoimmune diseases, today announces that the first patient has been enrolled in the Phase I clinical trial of its novel peptide therapy, ATX-GD-59, for the treatment of Graves’ disease. Apitope’s ATX-GD-59 has the potential to treat and prevent the production of stimulating antibodies against TSHR (thyroid stimulating hormone receptor) that lead to Graves’ disease. The Phase I trial will recruit up to 30 patients and is designed to assess the safety and initial efficacy of the product. Dr Simon Pearce, Professor of Endocrinology, Newcastle University, and Chief Investigator for the trial commented: “This is the first new therapy for Graves’ disease to be tested in over 50 years and is a significant step forward in the development of the drug. We are very pleased to be leading the first clinical trial of ATX-GD-59 which has significant potential to treat the underlying cause of this condition for the first time.” Dr Keith Martin, CEO of Apitope, said: “Graves’ disease is an autoimmune disorder that impacts over 5 Million people worldwide. There is no cure and the current treatment options available for patients have limited efficacy. Apitope is developing innovative products based on therapeutic peptides to treat a range of life-threatening autoimmune diseases, including rare conditions. We are delighted to progress the development of these innovative peptides which have the potential to treat Graves’ disease patients.” Graves’ Disease is the most common auto-immune disorder with prevalence rates of approximately 0.2% in Europe and 0.5% in the US (>2.4 million in EU and 2.6 million in the US); far outreaching the numbers of rheumatoid arthritis or type 1 diabetes patients. It is more common in women than men. This autoimmune endocrine disorder is linked to the thyroid gland and the overproduction of the thyroid hormones thyroxine (T4) and triiodothyronine (T3) caused by auto-antibodies. It can lead to high risk of long-term cardiovascular morbidity and mortality. About 30-50% of patients also suffer from Graves’ orbitopathy characterized by a protrusion of one or both eyes caused by the auto-antibody driven inflammation in extraocular eye muscles, connective and adipose tissue. Without treatment, it can lead to visual impairments and even blindness in a significant proportion (3-5%) of patients. It is therefore considered as a serious unmet need confirmed by The European Group on Graves’ orbitopathy (EUGOGO). Paediatric Graves’ disease is also recognised as an important unmet need with low levels of response. Approximately 50% of patients fail the current first line therapy. This provides a real opportunity for Apitope’s immunotherapy. In particular, early intervention may prevent moderate-to-severe or sight- threatening Graves’ orbitopathy from occurring or significantly ameliorate the symptoms without the need to suppress the whole immune system. This would greatly improve the health-related quality of life of the patients.
Apitope regains global rights to its novel treatment for multiple sclerosis from Merck KGaA, Darmstadt, Germany.
Chepstow, UK and Hasselt, Belgium: October 17 2016 − 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. 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.