Wednesday, January 13, 2021

Experimental Alzheimer’s Drug Donanemab Yields Promising Results in Phase 2 Trial

Courtesy: Eli Lilly/LinkedIn
By Nicholas Chan

While Biogen’s experimental Alzheimer’s treatment aducanumab faced yet another snag recently in its convoluted path toward FDA approval, other drugs companies are catching up: Eli Lilly and Co. announced on Monday that its investigational drug donanemab showed promise in a mid-stage clinical trial for patients with early symptoms of Alzheimer’s. 

The initial results from the drug’s Phase 2 clinical trial provide much needed hope for the Alzheimer’s community, which has seen setback after setback in drug development. Alzheimer’s drug trials have had a 99 percent failure rate, and many drug companies have bailed from developing therapies for Alzheimer’s. 

According to the Lilly’s news release, donanemab slowed the decline of cognition and ability to perform activities of daily living by 32 percent in participants who received the therapy, compared to those who received placebo, meeting its primary goal of statistically significant slowing of decline over 18 months. 

“The positive results we have obtained today give us confidence in donanemab and support its rapid and deep plaque clearance for the potential treatment of Alzheimer’s disease,” Dr. Daniel Skovronsky, Lilly’s chief scientific officer and president of Lilly Research Laboratories, said in a news release. 

The Phase 2 clinical trial involved 272 participants, which the Wall Street Journal reported to be a relatively small number of volunteers. Lilly said full trial results will be presented at a medical meeting and submitted for publication in a peer-reviewed clinical journal.

While there are FDA-approved drugs that can ease the symptoms of Alzheimer’s and improve quality of life, they do not target the hallmarks of the disease: beta-amyloid plaques and tau pathology. The Alzheimer’s community have long awaited a therapy that can alter the course of the disease. 

In a quest to develop an effective treatment, an increasing number of scientists and drug developers are turning to immunotherapies, like donanemab, aducanumab, as well as BAN2401 jointly developed by Eisai and Biogen. Each of these experimental Alzheimer’s treatments are designed to treat the disease by boosting people’s immune systems in a way that cuts down on beta-amyloid plaques. Immunotherapy has shown success in cancer treatment, and researchers hope that it may be effective to target neurodegeneration. Like aducanumab, donanemab targets beta-amyloid, a protein known to aggregate in the brains of people with Alzheimer’s disease. According to the company, donanemab targets a specific kind of beta-amyloid known as N3pG which can be rapidly cleared, allowing for short-term treatment of Alzheimer’s symptoms.

However, there are still questions about beta-amyloid as a target: Biogen’s aducanumab has been in the limelight recently as FDA advisers overwhelmingly said in November the company had failed to prove that the drug is an effective treatment for Alzheimer’s. Now, the drug awaits approval by the agency.

Lilly’s drug could be proof of concept. Chief Science Officer at the Alzheimer’s Association Maria C. Carrillo welcomed the initial results. 

“On behalf of the more than five million Americans living with Alzheimer’s, the Alzheimer’s Association is encouraged by these preliminary data,” Carrillo said. “We look forward to seeing the results of a second, larger Phase 2 trial, which is currently recruiting.”

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