Clinical Trials

Date: 2013-09-03

Type of information: Completion of the trial

phase: 1

Announcement: completion of the study

Company: Apitope (Belgium - UK) Merck Serono, a Merck KGaA company (Germany)

Product: ATX-MS-1467

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.

Disease: multiple sclerosis

Therapeutic area: Autoimmune diseases - Neurodegenerative diseases

Country: UK, Russia

Trial details:

• The primary endpoint of the trial is safety and tolerability, as assessed by adverse effects and MRI scans, while secondary endpoints are designed to provide an insight into the immunological activity of this investigational treatment. A range of doses of ATX-MS-1467 is being administered either intra-dermally or sub-cutaneously once every two weeks for 16 weeks, with a further 24 weeks of post-treatment follow up.

Latest news:

• • On September 3, 2013, Apitope, a drug discovery and development company focused on treating the underlying cause of autoimmune diseases, has announced completion with positive results of its second Phase I clinical trial of ATX-MS-1467. Examination of the MRI results (new Gd and total Gd enhancing lesions) demonstrated a significant decrease in the number of contrast-enhancing brain lesions (CEL) in patients with relapsing multiple sclerosis treated by intradermal injection of ATX-MS-1467. The same effect was not seen in the subcutaneously dosed group. These results will now need confirmation in appropriate Phase II trials. Completion of the study together with these positive MRI-based data allows Merck Serono, with whom Apitope is developing ATX-MS-1467, to develop plans for Phase II onwards.
• It has already completed successfully a Phase I clinical trial in six patients with secondary progressive MS (SPMS). Based on these encouraging preliminary results, a second Phase I clinical trial has been completed to assess the safety of ATX-MS-1467, as well as biological parameters, in a total of 43 patients with relapsing MS.
• The primary endpoint of the recently completed trial was safety and tolerability, as assessed by adverse effects and MRI scans, as well as secondary endpoints to identify early signs of efficacy. Review of the MRI data showed a significant decrease in new lesions; an early indicator of potential efficacy.
• • On November 26, 2012, Apitope has announced completion of recruitment into its second Phase I clinical trial of ATX-MS-1467 in patients with multiple sclerosis. Receipt of the first dose of study treatment by the last patient to be recruited prompted an undisclosed clinical milestone payment from Merck Serono, with whom Apitope is developing ATX-MS-1467. Under the terms of the agreement between the two companies, Apitope is responsible for this Phase I clinical trial of ATX-MS-1467. Merck Serono will be responsible for all development activities from the beginning of Phase II clinical trials. ATX-MS-1467 has already completed successfully a Phase I clinical trial in six patients with secondary progressive multiple sclerosis. Based on these encouraging preliminary results, a second Phase I clinical trial has been implemented to assess the safety of ATX-MS-1467 as well as biological parameters in a group of 40 patients with relapsing MS. This clinical trial is being carried out at two hospitals in the UK, as well as 12 clinics in Russia. Dosing of ATX-MS-1467 is expected to be complete by the end of 2012.

Is general: Yes