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Merck's Promising Early Alzheimer's Data Can't Quell Efficacy Concerns

 
• By Lucie Ellis-Taitt

The publication of Phase I analyses for Merck & Co.'s Alzheimer's therapy, verubecestat, may help to explain why the company decided to pursue costly Phase III studies without more data – but questions still remain around the drug's fundamental hypothesis that modulating the brain amyloid system will translate into a clinical response.

Phase I data for Merck & Co. Inc.'s BACE1 inhibitor, verubecestat, were published earlier this week in Science Translational Medicine (STM), spurring headlines that the first successful Alzheimer's therapy in over a decade may be upon us in 2017. But, while the early-stage data have been called encouraging, they are not enough to douse the flames of doubt that inevitably surround all Phase III Alzheimer's trials – an R&D space prone to late-stage failures. (Also see "Alzheimer's Disease: Learning the Lessons Of The Past To Prepare For The Future" - Scrip, 8 December, 2015.)

Merck confounded analysts when, on the back of a few early-stage studies, it launched two late-stage trials for verubecestat in...

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