Clinical Trials

Date: 2015-08-06

Type of information: Completion of patient enrollment

phase: 2

Announcement: completion of patient enrollment

Company: Merck KGaA (Germany)

Product: ATX-MS-1467/M2736

Action mechanism:

peptide. ATX-MS-1467 consists of four synthetic peptides that mimic naturally occurring peptides derived from human Myelin Basic Protein (MBP), a key autoantigen in multiple sclerosis. ATX-MS-1467 has been designed from naturally occurring MBP fragments and is intended to selectively inhibit the immune system's harmful attack on the protective myelin sheath surrounding the nervous cells while preserving the normal immune response to any harmful antigens, such as infections. ATX-MS-1467 has been developed by Apitope, a UK-based company developing antigen specific therapeutic peptides for the treatment of allergy and autoimmune diseases.

Disease: multiple sclerosis

Therapeutic area: Neurodegenerative diseases

Country: Germany

Trial details:

This multi-center, open-label, single arm, baseline-controlled Phase 2a trial evaluates the clinical and biological effects of ATX-MS-1467 in subjects with relapsing multiple sclerosis and assesses the maintenance of any such effects. (NCT01973491 )

Latest news:

• On August 6, 2015, Apitope 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. The product 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. The outcome of the study is expected in 2016. 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. Under the terms of the agreement, Merck Serono will complete all development activities from the beginning of Phase II clinical trials.