Alzheimer's Start-Ups At A Crossroads Between Discovery And The Clinic
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
With big Phase III failures heating debate about the amyloid hypothesis, small biotechs must convince investors that early research is pointed in the right direction, and larger ones must design clinical trials with care
You may also be interested in...
Lilly's Semagacestat Is Latest Alzheimer's Drug To Fail; Is Class At Risk?
Eli Lilly said August 17 it would halt development of its Phase III Alzheimer's drug candidate semagacestat, casting some doubt on the efficacy of novel gamma secretase inhibitor drugs and slowing Lilly's late-stage pipeline as the firm struggles to replace future revenues that will be lost to drugs going off patent
Lilly's Semagacestat Is Latest Alzheimer's Drug To Fail; Is Class At Risk?
Eli Lilly said August 17 it would halt development of its Phase III Alzheimer's drug candidate semagacestat, casting some doubt on the efficacy of novel gamma secretase inhibitor drugs and slowing Lilly's late-stage pipeline as the firm struggles to replace future revenues that will be lost to drugs going off patent
The Alzheimer's Divide
Issues of clinical trial design are at the forefront in Alzheimer's drug development. Researchers and investors are weighing the impact of late-stage failures, even as significant unknowns remain about disease mechanism and the correlation of biochemical markers and clinical effects. A fundamental question hangs over AD drug development, which is unique in many respects: in deciding how to move from Phase II into Phase III, what can you know and how can you know it?