Bristol, UK and Hasselt, Belgium – 6th August 2015 − Apitope, the drug discovery and development company focused on treating the underlying cause of autoimmune diseases, today announced that its partner, Merck Serono, has completed patient enrolment for the Phase IIa study of ATX-MS-1467 (also known as M2736), an investigational immune-tolerising agent. It is currently being tested in an open-label, one-arm proof-of-principle trial to evaluate its safety and effect on immune tolerance in subjects with relapsing multiple sclerosis (MS). The study involves frequent neuroimaging using magnetic resonance imaging (MRI). The outcome of the study is expected in 2016.
Dr. Keith Martin, CEO of Apitope, commented: “We are pleased that Merck Serono has completed recruitment into a challenging clinical trial. The results of this trial in patients with relapsing MS will hopefully continue to build on the positive data from our first two studies. It will also potentially provide further clinical support for Apitope’s approach in the treatment of serious autoimmune conditions.”
ATX-MS-1467 is a potential novel treatment developed with the aim of working with the immune system to treat the underlying cause of the disease by restoring immunological balance, instead of only treating the symptoms or suppressing the entire immune system.
Apitope has already 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 lesions) demonstrated a significant decrease of 78% in the number of contrast-enhancing brain lesions in patients with relapsing MS treated by intradermal injection of ATX-MS-1467.
Apitope is developing ATX-MS-1467 with Merck Serono, a market leader in the treatment of Multiple Sclerosis. Under the terms of the agreement, Merck Serono will complete all development activities from the beginning of Phase II clinical trials.