Once promising Alzheimer’s drug just failed a key test

Many investors and families had been counting on solanezumab to become the first approved medicine to slow progression of the disease, which the Alzheimer’s Association estimates will strike as many as 28 million Americans by mid-century.

As a result, manufacturer Eli Lilly and Company will not be seeking regulatory approval for the drug to be used to treat mild Alzheimer’s.

Yet, Anderson added, solanezumab’s failure doesn’t negate the drug’s approach to treating Alzheimer’s. Across its late-stage studies, Lilly tested the drug in more than 4,000 patients and failed to outperform a placebo in any of the trials.

When solanezumab and other drugs such as Pfizer’s bapineuzumab and Roche’s gantenerumab failed to show a benefit in patients with established Alzheimer’s dementia, clinicians suggested that giving them earlier could be the key to unlocking their efficacy.

The results of the trial are a big blow for the so-called “amyloid hypothesis”, the foremost theory of what causes Alzheimer’s, which holds that the brain stops functioning because of a build-up of sticky plaque known as amyloid.

Some researchers think the proteins trigger Alzheimer’s before they form the plaques, but they aren’t certain yet whether those proteins or the plaques are a cause of the disease, or if they’re just a symptom. The drug showed tentative promise in a small study a year ago, creating big expectations for data from larger trials. “Or is the strategy wrong?” said Stephen Salloway, neurology chief at Brown University in Providence, Rhode Island. Assuming a 10-15% sell off on a solanezumab failure, LLY share would trade at ~16.5x 2017 EPS with a ~3% dividend yield, which we believe is highly attractive given the diversified growth profile highlighted above … Lilly fell $7.88, or 10.4 percent, to $68.11, its lowest value in nearly two years. He noted solanezumab was being studied in a separate trial called “A4” among people with no Alzheimer’s symptoms but who have the brain plaques.

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. Dietary therapies, supplements and even a medical device also are being tried.

He said efforts and investment into dementia research must be redoubled.

Lilly, too, plans to stick with its Alzheimer’s research. That compound targets Alzheimer’s through a distinct pathway that does not involve beta-amyloid.

Though investors took the solanezumab results as a negative for Eli Lilly and competitors in the Alzheimer’s space, Wall Street analysts were more positive in the long-term.

Lilly said that other measures in the trial “directionally favored” the drug compared to placebo, but the differences were small.

“We’re going to continue our studies as planned”, said Samantha Budd Haeberlein, Biogen’s vice president of clinical development.

Lilly’s stock took a hit on the news, dropping almost 12% to trade near $67 per share. Biogen shares dropped 3.8 percent as investors attempted to gauge how the Lilly setback might affect other Alzheimer’s drug development programs. News stories displayed here appear in our category for Business and are licensed via a specific agreement between LongIsland.com and The Associated Press, the world’s oldest and largest news organization.

Republished with permission from STAT. Like this article? Follow him on Twitter where he goes by the handle @Longtermmindset or connect with him on LinkedIn to see more articles like this.