Clinical Trials

Date: 2017-02-21

Type of information: Results

phase: 2a

Announcement: results

Company: Apitope (UK)

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: relapsing multiple sclerosis (RMS)

Therapeutic area: Autoimmune diseases

Country:

Trial details:

Latest news:

• On February 21, 2017, Apitope announced positive results from the Phase IIa clinical study of 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 2 weeks for 20 weeks. Following a dose titration of 50 and 200 ?g in the initial 4 weeks of treatment a dose of 800?g 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. 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. Apitope is now preparing for a Phase IIb placebo controlled study to demonstrate clinical efficacy.