Experimental Alzheimer’s Drug from Eli Lilly Shows Promise in Early-Stage Patients
An experimental drug from Eli Lilly, called donanemab, has shown promising results in slowing the progression of memory and thinking problems in Alzheimer’s patients, according to researchers. The drug is most effective when administered early, ideally before patients develop symptoms of the disease. New trial data presented at the Alzheimer’s Association International Conference revealed that donanemab slows the progression of memory and thinking problems by about a third. However, if the drug is started when patients are only mildly impaired, the rate of improvement doubles to 60%.
The study involved over 1,700 patients and found that the drug’s results were less significant for older and later-stage patients, as well as those with higher levels of a protein called tau that is associated with Alzheimer’s disease progression. The findings highlight the importance of early detection and diagnosis in changing the trajectory of the disease.
Eli Lilly expects the U.S. Food and Drug Administration (FDA) to make a decision on whether to approve donanemab by the end of this year. Submissions to other global regulators are also underway and are expected to be completed by year-end. Donanemab is an intravenous antibody designed to remove deposits of a protein called beta-amyloid from the brains of Alzheimer’s patients, similar to the recently approved Leqembi from Eisai and Biogen.
Dr. Susan Kohlhaas, executive director of research & partnerships at Alzheimer’s Research UK, commented on Lilly’s data, stating that “These results provide further confirmation that removing amyloid from the brain can change the course of Alzheimer’s.” She added that the findings may help people affected by the disease if they receive treatment at the right time.
However, Lilly’s study revealed some side effects of amyloid-clearing antibodies. Brain swelling, a known side effect, occurred in more than 40% of patients with a genetic predisposition to develop Alzheimer’s. The study also reported that brain bleeding occurred in 31% of the donanemab group and about 14% of the placebo group. The deaths of three trial patients were linked to the treatment. Study investigator Dr. Liana Apostolova assured that while these side effects should not be taken lightly, most cases were manageable through monitoring with magnetic resonance imaging (MRI) or stopping the drug.
Lilly’s research also found that donanemab’s treatment effect continued to increase relative to placebo over the 18-month trial period, even for participants who had been taken off the drug after their amyloid deposits significantly decreased. The company believes this supports the idea that donanemab can be discontinued once amyloid is cleared from the brain.
The FDA recently granted standard approval to Leqembi, another Alzheimer’s disease-modifying treatment, clearing the way for wider insurance coverage of the drug. Both donanemab and Leqembi are being studied in large trials to determine if they can delay the onset of Alzheimer’s disease symptoms.
Alzheimer’s disease affects more than 6 million Americans and over 55 million people worldwide. Eli Lilly’s stock remained largely unchanged following the news, with shares trading at $449.98 on the New York Stock Exchange.