Eli Lilly and Company LLY and AstraZeneca plc AZN gained fast track status in the US for their experimental Alzheimer’s disease (AD) treatment, AZD3293.
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The drug, dubbed AZD3293, is part of a hot new class of Alzheimer’s drugs called BACE inhibitors which act to prevent the formation of a substance known as amyloid, whose build up in the brain is thought to be the main cause of the degenerative disease.
AZ and Lilly are in a race to market with Eisai/Biogen, Merck & Co and Amgen/Novartis, which all have BACE inhibitors in the clinic, but Lilly, Roche and Boehringer Ingelheim/Vitae Pharm have all scrapped candidates in recent years.
Craig Shering, project lead in global medicines development at AstraZeneca, said: “The fast track designation in the U.S. for this promising potential therapy reinforces the ambition of the AstraZenaca-Lilly BACE Alliance to advance science for patients and their families managing this devastating illness”.
The amyloid-targeting BACE inhibitor drug has started a second late-stage trial and – if successful – could be the first treatment for Alzheimer’s that targets an underlying mechanism in the disease. That trial is placebo-controlled and in an early Alzheimer’s population. In assessing the role of solanezumab, the company has shifted the primary endpoint exclusively to cognition, but expectations of a positive outcome are mild, since the molecule failed a pair of tests in phase 3.
AZD3293 is a BACE inhibitor that is now in phase III studies. The primary outcome for this particular trial would focus on cognitive change, which is believed to be a predictor for functional decline.
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Lilly and AstraZeneca’s alliance for the development and commercialization of AZD3293 goes back to 2014. By inhibiting BACE, the drug is meant to prevent or slow the formation and accumulation of amyloid plaque in the brain, in turn preventing or slowing the progression of the neurodegenerative disease.
