Apitope’s ATX-MS-1467 has reduced the number and volume of brain lesions with a promising safety profile, the company said about results of a test.
Apitope, the drug discovery and development privately owned company focused on treating the underlying cause of autoimmune diseases, has conducted a Phase IIa clinical study of its lead product candidate, ATX-MS-1467, for the treatment of patients with multiple sclerosis. The study had 19 patients with relapsing multiple sclerosis, who received the product intradermally (ID) every 2 weeks for 20 weeks. After a dose titration of 50 and 200 μg in the initial 4 weeks of treatment a dose of 800μg was given every 14 days for another 6 weeks.
Apitope said that 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, the company added.
Dr Keith Martin, Chief Executive Officer of Apitope, that the results will drive firther development. “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,” Martin said.
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.”