Roche confident in Alzheimer’s programmes, despite Lilly flop
Analysts seemed unconvinced, however, that the late-phase trial, which treated more than 2,000 patients with a mild form of Alzheimer’s disease, could have met its goal.
Eli Lilly and Company announced Wednesday one of their experimental drugs used by those with mild dementia due to Alzheimer’s disease, failed to meet standards in clinical trial. The dementia-causing brain disorder afflicts an estimated five million Americans and tens of millions globally, but has been a tough disease for the drug industry to crack because scientists don’t fully understand what causes it.
Eli Lilly has also been running “prevention” trials to see whether solanezumab might be able to stop people at particularly high genetic risk of Alzheimer’s from getting the disease.
“This will increase the interest in tau-lowering drugs for sure”, said Dr. Sam Gandy, director of Mount Sinai School of Medicine Center for Cognitive Health, referring to a different protein being targeted in earlier-stage research, including by Lilly, Johnson & Johnson and others. “We believed this was a highly risky trial”, he said in a research note.
On behalf of the millions of people living with Alzheimer’s disease and their families that we serve and represent, the Alzheimer’s Association is disappointed with the negative results of this clinical trial.
Eli Lilly had said in July that intermediate results were promising.
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Alzheimer’s research has already consumed more than $3 billion in spending over 27 years at Lilly alone, and the failure of its solanezumab treatment sent shares tumbling Wednesday. Lilly’s shares tumbled 10.5 percent. The drug is created to latch onto and isolate soluble forms of beta amyloid, the protein that experts believe turns toxic when it forms into clumps between the brain’s synapses. Biogen is planning further testing of its anti-amyloid drug, aducanumab. But it considers Alzheimer’s therapies key to its growth.
Based on the failure of the more than 2,100 patient study in Phase III clinical trials, Lilly said it won’t seek USA approval of solanezumab, the infused drug for mild dementia. “Disappointing, for sure, but for us it doesn’t shake our confidence going forward”. The company has a BACE inhibitor of its own in late-stage development in partnership with AstraZeneca, and it’s progressing a handful of early-stage therapies aimed at other Alzheimer’s targets. The Paris-based company is moving gradually, and perhaps seeking a partner, for a compound in early-stage development. Ricks hoped to take over a company that would be on the cusp of selling the world’s first drug that could slow Alzheimer’s.
Several studies test various diet and nutrition studies, including one late-stage experiment with vitamin E and selenium supplements. “We have a very robust pipeline of molecules that attack the disease in a number of different ways”, he said. The drug is now among the dozens of would-be Alzheimer’s treatments waylaid by clinical disappointment.
Yet, Anderson added, solanezumab’s failure doesn’t negate the drug’s approach to treating Alzheimer’s.
The aging of baby boomers, many of whom are caring for parents suffering from Alzheimer’s, has created a sense of urgency in the medical community.
Companies have been betting on a new generation of “magic bullet” drugs – solanezumab, aducanumab and gantenerumab.
“We think the amyloid hypothesis should continue to be studied”, incoming CEO David Ricks said during an interview with CNBC on Wednesday.