Apitope, a 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 two weeks for 20 weeks. Following a dose titration of 50 and 200µg in the initial four 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.