Shares in Biogen Idec rose as much as 10 percent Tuesday after the company indicated that it will "very aggressively" pursue a Phase III programme for its experimental Alzheimer's disease therapy BIIB037. Doug Williams, executive vice president of R&D, said that in a Phase Ib trial, BIIB037 reduced beta amyloid in the brain and improved cognition versus placebo in patients with early signs of the disease 54 weeks after starting treatment.
Company spokeswoman Ligia Del Bianco noted that the trial is being conducted in patients who have shown early, mild symptoms of the disease, but have not yet been diagnosed with it, and has been under way for at least a year. Biogen Idec indicated that the results come from an interim analysis of about 200 patients in the study. The data showed that BIIB037 reduced amyloid levels in the brain "in both a dose- and time-dependent fashion," while exhibiting acceptable levels of safety and consistency across endpoints
Biogen Idec noted that some patients exhibited amyloid-related imaging abnormalities (ARIA), with Williams explaining that most cases of ARIA, which were also observed among some patients who received placebo, were mild to moderate. "We believe we have a safety window to work with," remarked Williams, adding that the study is continuing, and additional doses could be explored. Williams indicated that Biogen Idec will present full data from the study at a future medical meeting.
BIIB037, also known as aducanumab, is designed to slow the progression of Alzheimer's disease by binding to amyloid plaques and clearing them from the brain. Biogen Idec licensed BIIB037 from Neurimmune Therapeutics in 2007 and signed a deal earlier this year to develop and commercialise the compound with Eisai.
Commenting on the news, Robert W. Baird analyst Chris Raymond cautioned "Alzheimer's disease is a veritable graveyard of failed development efforts so a tempered approach is advised here." Other drugs targeting amyloid plaques include Eli Lilly's solanezumab, and Pfizer and Johnson & Johnson's bapineuzumab. Last year, Eli Lilly announced plans to initiate a Phase III trial of solanezumab in patients with early-stage Alzheimer's disease following the failure of the therapy in patients with mild-to-moderate disease, although further analysis uncovered improvements in cognitive decline among patients with early-stage disease. Meanwhile, Pfizer and Johnson & Johnson terminated the development of bapineuzumab after the compound failed to meet its primary endpoints in two Phase III trials.
For related analysis, see ViewPoints: BIIB037 could be a big win for Biogen Idec – and the amyloid hypothesis.
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