Phase 3 Trials of Lanabecestat in Alzheimer’s Patients Stopped for Lack of Efficacy, Eli Lilly and AstraZeneca Announce

Phase 3 Trials of Lanabecestat in Alzheimer’s Patients Stopped for Lack of Efficacy, Eli Lilly and AstraZeneca Announce
Eli Lilly and AstraZeneca announced that they are stopping two global Phase 3 trials of lanabecestat, an amyloid beta-targeting treatment candidate for Alzheimer's, because of an apparent lack of benefit. Safety was not of concern in either trial. The decision follows recommendations by an independent data monitoring committee, which concluded that both trials — the AMARANTH Phase 2/3 study (NCT02245737)  in early Alzheimer’s patients and the DAYBREAK-ALZ Phase 3 trial (NCT02783573) in those with mild Alzheimer’s-associated dementia — were unlikely to meet their primary endpoints or goals. Both studies were assessing improvements in cognitive performance using a 13-item test called the Alzheimer's Disease Assessment Scale–Cognitive Subscale, or ADAS-Cog13. Lanabecestat is a small-molecule, oral inhibitor of the beta secretase cleaving enzyme (BACE), which is a key enzyme in the formation of amyloid beta — the main component of senile plaques. "The complexity of Alzheimer's disease poses one of the most difficult medical challenges of our time, and we are deeply disappointed for the millions suffering from this devastating disease," Daniel Skovronsky, MD, PhD, president of Lilly Research Labs, said in a press release.
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