Apitope Completes Enrollment for Phase IIa Trial for Relapsing Multiple Sclerosis

Apitope, a biocompany devoted to drug discovery and development for autoimmune diseases, announced that its partner Merck Serono has concluded the recruitment of participants for its Phase IIa Trial on relapsing multiple sclerosis, (known as a Phase IIa study of ATX-MS-1467 or also M2736)

The drug, ATX-MS-1467, is an under-investigation agent with an immune-tolerating action. Specifically, ATX-MS-1467 is a new agent developed to act on the immune system and target the underlying cause of autoimmune diseases by re-balancing the immune system. It is a new approach that focuses on the root-mechanism triggering the disease, instead of treating only disease symptoms or by completely shutting down the immune responses.

Previously, Apitope concluded two Phase I clinical trials: the first with six patients with secondary progressive multiple sclerosis, (SPMS — when patients initially diagnosed with relapsing remitting multiple sclerosis progress to secondary progressive multiple sclerosis, a stage characterized by fewer or no relapses and escalating symptom severity); the second with 43 patients with relapsing multiple sclerosis. Both trials evaluated both safety and several disease parameters. The results of magnetic resonance imaging showed a significant 78% reduction in contrast-enhancing brain lesions among relapsing multiple sclerosis patients when treated with ATX-MS-1467 (administered via intradermal route, i.e., injection in the dermis, one of the layers of the skin).

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Now, the Phase IIa study is testing ATX-MS-1467 in an open-label, one-arm proof-of-principle trial to determine its safety and immune-tolerance action in relapsing multiple sclerosis patients. During the study, patients’ brains are frequently assessed by imaging with magnetic resonance imaging. The study’s conclusions are expected in 2016.

Dr Keith Martin, CEO of Apitope noted, “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.”

Under the agreement, Apitope and Merck Serono are developing ATX-MS-1467, with the latter being responsible for the development for all research and commercial activities of Phase II clinical trials.