As Eli Lilly (LLY)'s ALZ Data Looms, Here Are Some Things Investors Need to Know
11/18/2016 5:58:32 AM
November 18, 2016
By Alex Keown, BioSpace.com Breaking News Staff
INDIANAPOLIS – Investors are waiting with bated breath for Eli Lilly (LLY) to reveal the results of its Alzheimer’s drug candidate, solanezumab.
Eli Lilly is in the midst of testing solanezumab on more than 2,000 patients with early Alzheimer’s disease in a late-stage trial. Results are expected in a few weeks, but this is a spot that solanezumab has been in before. In 2012, the drug failed to meet late-stage endpoints. However, with a new focus on milder-forms of Alzheimer’s and using a “delayed start” method, Lilly is positioning itself to take the lead in Alzheimer’s treatment. That focus was based on interim data released earlier this summer that suggested solanezumab works best when used in this manner. If the drug delivers as Lilly execs and countless patients and families hope, this could be the game-changing drug in treating the memory-stealing disease.
Alzheimer's disease, a type of dementia, affects 15 million people worldwide, a number that is expected to grow to 75 million by 2030 due, in part, to the lack of effective treatments. In total, there are about 50 million people suffering from some form of dementia worldwide. There are currently no drugs that target the cause of Alzheimer’s the most common form of dementia. There are several drugs on the market that help manage Alzheimer’s, but none treat the primary cause, including Eisai Co. (ESALF.PK)’s Aracept.
As investors wait, The Street’s Adam Feuerstein posted answers to many common questions about Alzheimer’s drugs and the elusive goal of developing a therapy to treat the disease. The first thing that Feuerstein noted is that no drug has been developed to treat Alzheimer’s. Like many other Alzheimer’s drugs in development, solanezumab targets amyloid plaque. Lilly’s injectable solanezumab, a monoclonal antibody, binds to forms of amyloid-beta after it is produced, allowing it to be cleared before it clumps together to form beta-amyloid plaques. While not a cure for Alzheimer’s, solanezumab provide patients with greater cognitive abilities. Early data shows patients have about a 35 percent improvement.
For investors, Feuerstein lays out some important points that will signify if Eli Lilly has hit a home run. If solanezumab “hits the cognitive primary endpoint with statistical significance and hits the functional secondary endpoint, also with statistical significance,” that means the drug is almost assuredly going to receive approval by the FDA, he said. Feuerstein lays out several other scenarios for trial results that will determine the future path for Eli Lilly and solanezumab.
While Feuerstein provides his readers with some insight into how analysts are looking at the stock, one of the more noteworthy points he makes is how rival drugmaker Biogen (BIIB) will react to the Eli Lilly data. Biogen is also developing its own amyloid plaque targeting drug aducanumab. If Eli Lilly’s drug is successful, Feuerstein said investors will also likely react positively to Biogen “because, finally, the amyloid hypothesis will have been confirmed.” Feuerstein also added that there is belief on Wall Street that aducanumab is superior to solanezumab. Biogen is currently enrolling its Phase III trial, but if solanezumab turns out to be a failure, Feuerstein said “sentiment on Biogen and aducanumab will also diminish.”
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