ATX-MS-1467 is an experimental drug treatment for relapsing remitting multiple sclerosis. It is injected under the skin once every two weeks.
ATX-MS-1467 for relapsing remitting MS: Phase II
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ATX-MS-1467 is intended to selectively inhibit the immune system's harmful attack on the nerve coating by reducing T-cell response to myelin.
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First phase I study in secondary progressive MS showed a reduction in the T-cell response to myelin basic protein. Second phase I study in relapsing remitting MS found significant decrease in active MS lesions.
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No side effects have been reported to date.
Some of the damage to nerves in MS may be caused by T-cells (a type of white blood cell or lymphocyte) which mistakenly identify the myelin coating of nerves as 'foreign'. Myelin basic protein (MBP) is believed to be an important component in the myelination of nerves in the brain and spinal cord. ATX-MS-1467 consists of four short peptides (chains of amino acids, the building blocks of proteins) derived from MBP. ATX-MS-1467 is intended to selectively inhibit the immune system's harmful attack on the nerve coating by reducing T-cell response to myelin.
ATX-MS-1467 is injected under the skin once every two weeks.
What are the results so far?
In a phase I/IIa study, 6 people with secondary progressive MS received increasing doses 7 to 14 days apart. The results showed a reduction in the T-cell response to myelin basic protein and the treatment was found to be safe and well tolerated in this small group of people. The study was not designed to provide data on clinical efficacy.
In a second phase I study, 43 people with relapsing remitting MS received increasing doses 14 days apart. There was a significant decrease in the number of gadolinium-enhancing lesions seen on MRI in the group treated with intradermal injections.
Further details of this completed study.
Phase II study for relapsing remitting MS
In a phase II study, 37 participants with relapsing remitting MS were treated with increasing doses of ATX-MS-1467 every two weeks for the first four weeks, then continued with the full dose every two weeks for a further 16 weeks. The number of gadolinium-enhancing lesions seen on MRI were significantly reduced on treatment and remained reduced during a 16-week follow-up period after the last treatment.
Further details of this completed study.
What further research is planned?
Apitope has been acquired by Worg Pharmaceuticals who have indicated that they intend to continue development of ATX-MS-1467, now renamed WP1303.
In the phase I and II studies, side effects were mild or moderate, including mostly injection site reactions, two cases of hair loss, and one case of diarrhea (which resulted in discontinuation of treatment).
