Once-promising Eli Lilly Alzheimer's Treatment Fails

Once-promising Eli Lilly Alzheimer's Treatment Fails

Some Alzheimer's specialists not included in trials testing hostile to anti-amyloid drugs, said they were not astonished by Lilly's outcome, saying they mirror a developing logical comprehension of Alzheimer's as a sickness with a multi-pronged course of causes, including amyloid development. Its shares dropped 3 percent in a busy premarket trading session. Based on these results, the company not surprisingly will not file for approval.

Roche Holding AG, meanwhile, is studying a potential anti-amyloid drug in people who are genetically programmed to develop the disease but don't yet have symptoms.

Now approved drugs can do no more than ease some of the symptoms of the disorder and a successful disease-modifying treatment would be virtually guaranteed multibillion-dollar annual sales, industry analysts believe.

More than 5 million Americans have Alzheimer's disease.

Biogen is racing to complete Phase III trials of aducanumab, which is created to clear beta amyloid that has already formed brain plaques. The latter drug works upstream of solanezumab by inhibiting an enzyme involved in the conversion of amyloid precursor protein (APP) into amyloid beta. The company said it's still committed to Alzheimer's, and that it has other compounds it is studying.

Several leading Alzheimer's disease researchers have said drugmakers should focus instead on dealing with tangles, or twisted fibers of a protein in the brain called tau, as a more promising approach. Analysis of comparable patients from earlier studies of solanezumab had appeared encouraging, but this latest trial indicated only small benefit, not enough to warrant trying to market the drug.

An immunotherapy drug hailed as a potential game changer in the treatment of Alzheimer's has missed its targets in a large-scale clinical trial. Even though both drugs rely on the hypothesis that reducing amyloid beta plaques can be successful, they note the Biogen medicine works differently. "Though the news is disappointing, it is not completely unexpected to those who have supported prevention trials", said Randall Bateman, Washington University, St. Louis, who leads the DIAN-TU prevention trial. "Lilly never seemed to have a great answer for why they picked the solanezumab dose they did".

Anderson suggested dosing decisions by Lilly could have contributed to solanezumab's failure.

Along with a recently started trial of solanezumab in even earlier-stage (prodromal) Alzheimer's, that includes AstraZeneca-partnered BACE inhibitor AZD3293, which is in Phase III testing. Biogen is set to present data on aducanumab at next month's Clinical Trials on Alzheimer's Disease meeting. Lilly and other companies have developed drugs that try to stop the buildup of a sticky protein in the brain known as beta amyloid - believed by many to be the primary culprit in the disease. "We need to redouble our efforts". "Driven by new product launches, we continue to expect to grow average annual revenue by at least 5 percent between 2015 and 2020".

The antibody treatment, solanezumab, failed to achieve significant slowing of memory loss and mental decline caused by the disease.

More than 5 million people in the USA have Alzheimer's, making it the most common form of dementia. Some Alzheimer's drugs have caused unsafe and even fatal brain swelling.

"We're saddened and disappointed", said Maria Carrillo, chief science officer at the Alzheimer's Association in Chicago, which funds research programs and lobbies for more federal money to finance studies.

Now, Lilly will have to re-evaluate its continued development of Alzheimer's drugs while also highlighting the rest of its pipeline.