KOL Views: How much life did BAN2401 just breathe back into Alzheimer’s drug development?

Biogen and Eisai’s BAN2401 had been largely written off after missing the primary endpoint of a Phase II trial to treat Alzheimer’s disease (AD) after 12 months, but the partners announced late last week that the anti-beta amyloid mAb had since achieved a statistically significant slowing of disease progression versus placebo after 18 months.

To provide FirstWord readers with rapid feedback on what the readout may mean for BAN2401 and AD drug development, we are hosting an expert call with a key opinion leader (KOL) later this week.

Key topics that will be discussed during the call include, among other things… feedback on BAN2401’s positive top-line readout; what will you be most interested in seeing when the dataset is actually revealed; did BAN2401’s inability to differentiate itself from placebo after 12 months have any impact on how impressed you are by the 18-month readout; the Phase II trial was powered to have an 80-percent probability of showing a 25-percent benefit on slowing disease progression per the ADCOMS scale – what is the minimal magnitude of benefit that you would say is still meaningful; thoughts on Eisai’s internally-developed ADCOMS endpoints and any concerns about using it as the basis for approval; Biogen and Eisai left open the possibility of seeking approval based on these results – given the dearth of options, do you see this as plausible; how might this impact confidence in the amyloid hypothesis; any read-through to Biogen/Eisai’s aducanumab?

Ask the expert!

Furthermore, we invite FirstWord Pharma readers to submit their own questions for consideration. Please click here to do so. We can't guarantee that all questions submitted will be asked due to time constraints, but we will do our utmost to cover the important issues relating to the development of and commercial prospects for AD therapeutics.

We endeavour to provide feedback from KOLs as quickly as possible. Interview content will be published for FirstWord Pharma PLUS subscribers to read. To be notified when the interview content is available please click here.

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As always, FirstWord would very much like to receive your feedback and suggestions.

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