Lilly/BioMS Forge Ahead With MS Drug After Phase II/III Interim Look
This article was originally published in The Pink Sheet Daily
Executive Summary
Dirucotide gets positive nod from DSMB; Lilly to pay $10 million milestone to BioMS.
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Lilly/BioMS Medical's novel multiple sclerosis drug dirucotide (MBP8298) got a positive nod from an independent data safety monitoring board in an interim look at an ongoing Phase II/III pivotal trial. Based on a review of safety and efficacy data from the first 200 patients to complete the MAESTRO-01 study, the board recommended the study continue to completion. It's encouraging news for the novel MS drug, which could become a tailored therapy targeting patients with HLA-DR2 and/or HLA-DR4 immune response genes. Final data from the study is anticipated in the second half of 2009. Pending results, the companies could consider filing dirucotide in Canada in Europe in late 2009, based on data from the single pivotal trial, which is being conducted in the two regions, BioMS said. A second pivotal trial, MAESTRO-03, is also ongoing in the U.S., with data anticipated in summer 2010. MAESTRO-01 is being conducted in 611 secondary progressive MS patients with the HLA-DR2 and/or HLA-DR4 genes. The primary endpoint is a statistically and clinically significant increase in the time to progression of the disease, as measured by the Expanded Disability Status Scale, in patients with HLA-DR2 and or/HLA-DR4. MS patients with those genes represent 65 percent to 75 percent of all MS patients, according to the firms. Based on the outcome of the DSMB review, Lilly will pay BioMS a $10 million milestone payment. The two companies signed a collaboration agreement for dirucotide in December, giving Lilly its first late-stage candidate for MS. Lilly offered $87 million upfront and potential milestones of up to $410 million (Also see "Lilly Inks Deal With BioMS For Phase III Multiple Sclerosis Compound" - Pink Sheet, 17 Dec, 2007.). Dirucotide, a synthetic peptide, is believed to work by inducing or restoring immune tolerance in the face of an immune attack. The degree of immunomodulation achieved in patients depends on the interaction between the peptide, HLA molecules and T cells. In a Phase II study published in 2006, dirucotide delayed median time to disease progression for five years versus placebo in patients with progressive MS with HLA types DR2 and/or DR4. In addition to the two MAESTRO trials, the drug is also being studied in a Phase II trial for relapsing remitting MS in Europe, MINDSET-01. Data from that trial could be available in first quarter 2009. -Jessica Merrill ([email protected]) |