Lilly, AstraZeneca Alzheimer's Trial Advances
Eli Lilly and AstraZeneca are moving into Phase 3 of their Amaranth study of AZD3293, an oral beta secretase cleaving enzyme (BACE) inhibitor that could be a potential treatment for early Alzheimer's disease.
The Phase 3 trial, called Daybreak, will investigate the safety and efficacy of the test drug over a two-year treatment period, along with the hypothesis that it is a disease-modifying treatment. Beginning in this year’s third quarter, the companies hope to enroll about 2,200 patients with mild Alzheimer’s in 14 countries.
An independent data monitoring committee has recommended that the study continues without modification after conducting an interim safety analysis, which was not designed to review efficacy.
Under the agreement signed in 2014, Lilly will pay AstraZeneca up to $500 million in development and regulatory milestone payments. With AZD3293 moving into Phase 3, AstraZeneca will receive a milestone payment from Lilly.
The US drugmaker is leading clinical development in conjunction with British-Swedish company’s researchers, while AstraZeneca will be responsible for manufacturing. The pharmaceutical producers will share responsibility for commercialization of the molecule as well as sharing all future costs equally for development and commercialization, in addition to net global revenue post-launch.
In Phase 1 studies AZD3293 is said to have shown lower levels of amyloid beta in the cerebro-spinal fluid of people with Alzheimer's and healthy volunteers. The companies hope that inhibiting BACE, an enzyme associated with the development of amyloid beta, will prevent the formation of amyloid plaque and eventually slow the progression of the disease.
