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Dirucotide (MBP8298) Phase II Study fails to meet primary endpoints in Multiple Sclerosis patients 30 January 2009

BioMS Medical Corp. announced that the MINDSET-01 study, an exploratory phase II clinical trial evaluating dirucotide in patients with relapsing-remitting multiple Sclerosis or MS failed to meet primary endpoints, annualized relapse rate or associated secondary MRI endpoints.

Further, the company said Dirucotide did meet mean change from baseline in the Expanded Disability Status Scale and the Multiple Sclerosis Functional Composite score.

Dirucotide has been evaluated in two ongoing phase III trials in the United States, Canada and Europe. Dirucotide was generally well tolerated and recorded common side effects were redness and burning sensation at the injection site.

Source: RTTNews © 2009 RTTNews (30/01/09).

Ian,

Although the topline results (for relapse rate and lesion activity) are definitely disappointing, I think it's too early to say that Dirucotide is no use for RRMS. According to BioMS's press release, Dirucotide did provide a statistically significant benefit in terms of EDSS and MFCS. So it might turn out to be usefull for RRMS as part of a two-drug regimen. It would hopefully reduce neurodegeneration, while another drug would be used to reduce inflammation.

It'll be interesting to see the results of the phase III for SPMS.