Eli Lilly’s monumental effort to prove once and for all that solanezumab could work in delaying Alzheimer’s has ended in total failure. The pharma giant announced this morning that the drug failed its third Phase III effort at Lilly, sending its stock into a tailspin.
Back in 2012, investigators for Lilly convinced the top execs at the company that they had seen real, tangible benefits for early-stage patients taking the drug, designed to eliminate deposits of amyloid beta in the brain. The data, they felt, warranted another clinical odyssey in Phase III, even though that study had failed. And CEO John Lechleiter was a stout advocate throughout, willing to invest heavily in the study. But in the end, the drug offered nothing but false hope to millions of patients, failing to bend the curve on cognitive declines or the ability of patients to function better.
Lilly will take a modest $150 million charge in the fourth quarter — just a fraction of what it has spent on this drug.
Its shares plunged 14% on the news. And the damage extended to other companies pursuing the amyloid beta theory. Biogen, which has promoted the prospect of aducanumab, watched its stock plunge 10% in pre-market trading. And Axovant, a company that nabbed a failed Alzheimer’s drug from GSK and put it back into the clinic, saw its shares drop 18%, even though their drug goes after a completely different target.
The failure here casts a particular pall over the amyloid beta theory. The toxic protein clusters in patients’ brains are considered the most likely suspect for triggering the disease, which afflicts millions. Merck, Biogen, Lilly and others all have other programs in the pipeline that look at various ways to reduce the level of amyloid beta in the brain. And those programs will continue, along with the debate over what targets should be used in future studies.
Noted Leerink’s Seamus Fernandez:
This result will no doubt cast a shadow over LLY’s Alzheimer’s Disease (AD) pipeline portfolio, which is heavily based on the beta amyloid hypothesis. Other competitors’ programs based on this hypothesis will probably continue, but this will likely have negative read-through on these results in the short term.
The failure at Eli Lilly also underscores the disastrous record that Alzheimer’s drugs overall have had in the clinic for more than a decade, with a near-universal failure rate. Eli Lilly has had one of the longest running R&D efforts in Alzheimer’s, with some jaw-dropping setbacks along the way. It also tried to go after Alzheimer’s with semagacestat, only to find that the drug apparently increased the risk of the disease. Investigators and execs, though, have been steadily lured on by the prospect of mega-blockbuster sales, often cruelly touting the potential of a therapy, only to admit failure in the end.
“The results of the solanezumab EXPEDITION3 trial were not what we had hoped for and we are disappointed for the millions of people waiting for a potential disease-modifying treatment for Alzheimer’s disease,” said Lechleiter. “We will evaluate the impact of these results on the development plans for solanezumab and our other Alzheimer’s pipeline assets.”
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