Dirucotide
Dirucotid, also known as MBP8298, is an experimental immunomodulatory drug that has been tested for the treatment of relapsing-remitting and chronic progressive forms of multiple sclerosis (MS). At Dirucotid is a synthetic peptide consisting of amino acids 82-98 of myelin basic protein ( " MBP ").
Action principle
As imitated myelin protein Dirucotid aims to draw misguided in MS immune response against the protective covering of the nerves ( myelin sheath ) on themselves and gradually reduce and then restore immune tolerance.
The main point of the MS -related B- and T-cells is encoded in the sequence 82-98 of MBP systhetischen. So that these B and T cells should be neutralized and, in addition, the distribution autoaggressive antibodies are reduced.
It is assumed that only patients who carry certain genetic variants in itself (HLA haplotype DR2/DR4 ), benefit from treatment with Dirucotid. This is true for about 65-75 % of people suffering from MS. In the overall population, the probability is only between 20 and 30%.
Clinical Development
Dirucotid was discovered at the Canadian University of Alberta in Edmonton. The drug was then licensed to the company, also based in Edmonton BioMS Medical. Since the end of 2008, the U.S. company Lilly involved in the development of Dirucotid.
The drug was tested in a small phase II study in 32 patients with progressive MS over two years double-blind. No difference from placebo in the overall study showed. When restricting the analysis to the 20 patients who are carriers of the HLA haplotype DR2/DR4, however, showed a benefit of treatment with Dirucotid. In a follow-up of these 20 patients over a further five years, indicated that the median time was prolonged until progression of MS disability after treatment with Dirucotid of 18 to 78 months.
2005 Phase-II/III-Studie began on the effectiveness of Dirucotid with secondary progressive MS and 2006 a phase II trial in relapsing-remitting MS.
In the studies Dirucotid is injected intravenously at intervals of six months.
The drug was well tolerated in the published study. There were only reddening and burning at the injection site.
Having not been achieved in a Phase III study for SPMS, the primary and some secondary endpoints, all studies have been aborted at Dirucotid.