Eli Lilly and AstraZeneca gained an advantage in the race to develop a BACE inhibitor to treat Alzheimer’s.
The Food and Drug Administration provided a fast-track review for AZD3293, an oral beta secretase cleaving enzyme inhibitor (BACE) presently in Phase 3 clinical trials focusing on an early Alzheimer’s population, according to an announcement from both companies.
“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. “BACE inhibitors have the potential to transform the treatment of Alzheimer’s disease, one of the biggest challenges facing medical science today.”
Studies so far have shown this class of drugs is capable of reducing amyloid beta levels found in the cerebro-spinal fluid of healthy volunteers and people with Alzheimer’s.
Eli Lilly entered this partnership with AstraZeneca in 2014 after the company ended its own BACE program due to liver toxicity issues, reported FierceBiotech. Lilly serves as the lead for clinical development while AstraZeneca will take charge of manufacturing. Commercialization responsibilities will fall under both organizations’ oversight along with sharing all future costs associated with this process.
Data for the molecule’s final primary outcome in the first trial won’t arrive until August 2019. Both firms will kick-start a second placebo-controlled Phase 3 trial in the third quarter of 2016 targeting a mild Alzheimer’s dementia. The primary outcome for this particular trial would focus on cognitive change, which is believed to be a predictor for functional decline.
A fast-track designation guarantees these collaborators enter an expedited process for reviewing potent new therapies.
Filed Under: Drug Discovery