Biogen takes Alzheimer’s drug straight to phase III

Following positive phase I results for its Alzheimer’s disease candidate BIIB 037, Biogen has decided to move straight to phase III trials.

Biogen’s executive vice president of research and development, Doug Williams, said the drug had shown a significant effect on cognition among patients in the study and there was a decrease in amyloid deposits on the brain after 54 weeks of use.

Shares in Biogen rose almost 7 per cent on the news.

Speaking at the Deutsche Bank Biofest Conference in Boston, Williams said the full data would be presented at an upcoming medical meeting. He stressed that, though the studies were early-stage, they had presented “encouraging enough data to really have us pull the trigger on moving forward aggressively to plan for phase III”. No timeline was given for the next step.

Many other drug hopes for Alzheimer’s disease have fallen at phase III despite initial success at phase I, including Lilly’s solanezumab and Pfizer/Johnson & Johnson’s bapineuzumab, both amyloid-targeting antibodies. Lilly is now working with AstraZeneca on an oral beta secretase cleaving enzyme (BACE) inhibitor and Biogen is also keeping its options open and is developing one of its own with Eisai.

With the rapid increase in incidence of the illness, any prospect of a treatment is welcome news, although there has been much debate about whether anti-amyloid drugs can work, given previous failures.

However, some scientists believe earlier intervention with a combination of two amyloid-targeting drugs could be the answer. Novartis is one company taking this approach and will work with the Banner Alzheimer’s Institute on a trial of around 1,300 cognitively-healthy people who are at high risk genetically of developing the disease. The first patients for this programme will be enrolled in early 2015, although the drugs’ effectiveness may take years to assess.


Amyloid hypothesis: down but not out in Alzheimer’s disease?

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