Merck's Promising Early Alzheimer's Data Can't Quell Efficacy Concerns
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.
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A new trial for CNP520 will see if the Amgen/Novartis BACE1 inhibitor can prevent, stop or slow Alzheimer's disease progression in pre-symptomatic patients, but recruiting enough patients with the APOE4 gene will require a massive screening effort.
Biogen rose and fell based on the company’s latest aducanumab results, but the Clinical Trials on Alzheimer’s Disease meeting Dec. 8-10 showed that regardless of Lilly’s Phase III solanezumab failure, companies continue to invest in amyloid and other hypotheses, including BACE, gamma secretase and other programs.
Lilly will make its first presentation of solanezumab data from the recently failed Phase III EXPEDITION3 study during the Clinical Trials in Alzheimer’s Disease meeting where researchers will discuss amyloid beta and other hypotheses in Alzheimer’s disease Dec. 8-10 in San Diego.