Eli Lilly, AstraZeneca Drop Two Late-Stage Alzheimer's Drug Trials -- Update

By Preetika Rana and Peter Loftus 

AstraZeneca PLC and Eli Lilly & Co. on Tuesday scrapped two late-stage trials of an experimental Alzheimer's drug they were codeveloping, the latest blow in the long quest to find a breakthrough for the memory-robbing disorder.

The companies said the decision was taken after an independent data monitoring committee concluded that trials associated with lanabecestat, the experimental drug, wouldn't achieve their original goals. The companies said the treatment wasn't working as well as they had hoped and ending the trials wasn't a result of any safety concerns.

An AstraZeneca spokesman said the two will continue to jointly pursue an early-stage trial of another experimental Alzheimer's drug. Lilly separately has other Alzheimer's compounds in clinical trials, according to a company spokeswoman.

Current treatments for Alzheimer's can alleviate symptoms, but don't slow the condition's underlying progression. The brain disease affects an estimated five million Americans, and tens of millions globally, but has been tough for the drug industry to crack because scientists don't fully understand what causes it.

Pfizer Inc. in January said it would stop trying to discover new drugs for Alzheimer's and Parkinson's disease. Axovant Sciences Ltd. and Biogen Inc. have also reported disappointing results from Alzheimer's research.

Lanabecestat is known as a BACE inhibitor, aimed to prevent an enzyme from producing the sticky substance known as amyloid that builds up in the brains of Alzheimer's patients. Many drugmakers have pursued the theory that targeting amyloid could slow or halt the progression of Alzheimer's.

But another BACE inhibitor, from Merck & Co., failed last year in a clinical trial of patients with mild to moderate Alzheimer's.

Other drugs targeting amyloid in different ways also have failed to help patients in trials over the past decade, including those developed by Lilly, Pfizer and Johnson & Johnson . The mounting setbacks of amyloid-targeting drugs have raised doubts about that approach.

Some companies have stuck with the amyloid hypothesis but have tested such drugs in earlier stages of the disease, on the belief that the older failed trials had patients whose disease was too advanced to be helped. But the Merck drug also failed to help patients with an earlier-stage form of the disease known as prodromal Alzhiemer's, in a separate study that was halted earlier this year.

Merck and other companies have also focused drug development on a different protein, tau, that forms twisted proteins in the brains of Alzheimer's patients.

Some companies say they will continue to look because the need is high and a breakthrough could potentially reap big commercial rewards. Lilly, which has spent three decades trying to find a blockbuster and in 2016 shelved a different Alzheimer's compound it spent $1 billion developing, said it was committed to further research despite the latest setback.

"We won't give up on finding a solution for Alzheimer's patients," Daniel Skovronsky, president of Lilly Research Labs, said in the joint statement.

Indianapolis-based Lilly joined forces with the U.K.'s AstraZeneca to co-develop lanabecestat in 2014. Lilly was responsible for the two trials -- one for patients with early Alzheimer's and the other for those suffering a milder form of the disease -- while AstraZeneca agreed to take on manufacturing. More than 3,000 patients were enrolled across the trials, which were expected to conclude as early as next year, the AstraZeneca spokesman said. Follow-on studies would have lasted until 2021.

Write to Preetika Rana at [e-mail] and Peter Loftus at [e-mail]

(END) Dow Jones Newswires

June 12, 2018 11:15 ET (15:15 GMT)

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