The Indianapolis drugmaker’s share price slipped Wednesday morning after it announced that it will conduct the additional, late-stage study of solanezumab in mild cases of Alzheimer’s. Lilly hasn’t determined details of the study but said it will start no later than next year’s third quarter.
In August, Lilly said the intravenous treatment failed to slow memory decline in two late-stage studies of about 1,000 patients each. But scientists saw a statistically significant slowing when they combined trial data. Pooled results found 34 percent less mental decline in mild Alzheimer’s patients compared with those on a fake treatment for 18 months.
Researchers also saw a statistically significant result when they examined a subgroup of patients with mild cases of Alzheimer’s disease.
Doctors and analysts expected Lilly to conduct another study to confirm the drug’s benefit before seeking approval. The additional study could provide data that helps Lilly build a better case with U.S. regulators.
But the new study will likely take at least a few years because researchers will have to measure over time a patient’s rate of cognitive decline, which involves the ability remember things.
Drugmakers have tried and failed for years to develop successful treatments for the disease, and patients and doctors are anxious for something that can slow its progression.
Solanezumab binds to beta-amyloid protein, which scientists believe is a key component to sticky plaque that basically gums up the brain of a patient with Alzheimer’s disease. The drug is designed to help the body remove the protein from the brain before it can form that plaque.
Current treatments like Pfizer Inc.’s Aricept try to control symptoms of the disease. Analysts have said a treatment that does more than manage symptoms such as memory loss, confusion and agitation could be worth billions of dollars in annual sales. But drugmakers first have to spend a massive amount on testing and clinical development to produce such a drug.
"When you go for the blockbuster, you have to pay for the blockbuster, either in money or time," WBB Securities analyst Steve Brozak said regarding Lilly’s announcement.
More than 35 million people worldwide have dementia, a term for brain disorders that affect memory, judgment and other mental functions. Alzheimer’s is the most common type. Many Alzheimer’s patients typically live four to eight years after diagnosis, as the disease gradually erodes their memory and ability to think or perform simple tasks.
In the United States, 5.4 million people have Alzheimer’s, which is the country’s sixth-leading cause of death. The number of Alzheimer’s patients in the U.S. is expected to jump to 16 million by 2050, and costs for care are expected to skyrocket.
Lilly shares fell 3 percent, or $1.54, to $49.06 in morning trading while the Standard & Poor’s 500 index climbed slightly. Lilly’s stock price was still up more than 15 percent since Lilly announced initial study results in August for solanezumab.