Lilly, AstraZeneca nab fast-track review for BACE inhibitor in Alzheimer’s

Partners Eli Lilly ($LLY) and AstraZeneca ($AZN) got a leap ahead in the BACE inhibitor race as they secure a fast-track designation from the FDA for Phase III candidate AZD3293. The oral beta secretase cleaving enzyme (BACE) inhibitor is in testing to treat Alzheimer’s disease.

This BACE inhibitor, along other similar late-stage efforts from partners Biogen ($BIIB) and Eisai as well as from Merck ($MRK), is expected to prevent the buildup of beta-amyloid in an effort to slow or halt the progression of Alzheimer’s disease. The BACE inhibitor from Eli Lilly and AstraZeneca, AZD3293, is the only one of this late-stage trio to have secured fast track designation.

"The Fast Track designation in the U.S. for this promising potential therapy reinforces the ambition of the AstraZeneca-Lilly BACE alliance to help advance science for patients and their families managing this devastating illness," said Craig Shering, AZD3293 Project Lead in Global Medicines Development at AstraZeneca, in a statement. "BACE inhibitors have the potential to transform the treatment of Alzheimer's disease, one of the biggest challenges facing medical science today."

The candidate has entered the Phase III portion of a Phase II/III trial that started in 2014; it’s not slated to have final primary outcome data until August 2019. That trial is placebo-controlled and in an early Alzheimer’s population. It’s starting a second placebo-controlled Phase III trial this quarter in a mild Alzheimer’s disease population; the primary endpoint in both is cognitive change, which is thought to predict and precede functional decline.

Eli Lilly has 7 clinical candidates in Alzheimer’s disease, in addition to amyloid and tau imaging agents. It’s slated to have Phase III data from a Phase III trial of solanezumab for mild Alzheimer's in amyloid positive patients later this year. It has changed the endpoint from a co-primary endpoint of cognition and function to one solely focused on cognition. But solanezumab doesn’t offer a lot of hope--that candidate has already failed a pair of Phase III tests.

Lilly partnered with AstraZeneca in 2014 on AZD3293, with Lilly assuming the lead on clinical development in the 50/50 deal. The deal for the AstraZeneca candidate came after Lilly had killed its own BACE program in Alzheimer’s due to liver toxicity issues.

The controversial thesis for BACE inhibitors is that the reduction of amyloid beta, which accumulates in the brain of Alzheimer’s disease patient, can prevent the formation and accretion of amyloid plaques and in turn slow disease progression.

- here is the release

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