Lilly Enters Collaboration for Phase 3 Trial of Alzheimer’s Drug

Eli Lilly and Company and Banner Alzheimer’s Institute recently entered into a research collaboration as part of the planned Phase 3 clinical trial evaluating Lilly’s Alzheimer’s drug, donanemab.

The placebo-controlled trial, TRAILBLAZER-ALZ 3, will evaluate whether treatment with donanemab can slow clinical progression of Alzheimer’s disease in patients at risk for cognitive and functional decline related to the disease.

Banner will leverage its expertise in Alzheimer’s prevention trials and support enrollment of trial participants with and without the e4 type of the apolipoprotein E gene through the Alzheimer’s Prevention Registry GeneMatch program.

Additionally, the collaboration will introduce a more virtual approach to evaluating Alzheimer’s prevention therapies, an Eli Lilly and Company spokesperson said.

"This collaboration combines Lilly's more than 30 years of dedication to Alzheimer's research with Banner's unique expertise and showcases our collective commitment to partner within the health care community to find potential treatments to end this devastating disease," Mark Mintun, MD, vice president of pain and neurodegeneration at Eli Lilly and Company, said in the announcement.

“While these types of trials are challenging to enroll and conduct, Lilly, together with Banner, is proud to undertake the opportunity to bring about this new study in an area of high unmet medical need,” Mintun continued.

Donanemab is an investigational antibody that targets a modified form of beta amyloid, N3pG.

Previous Phase 2 trial results showed that donanemab slowed cognitive and functional decline in patients with early symptomatic Alzheimer’s disease and slowed tau accumulation across key brain regions in patients. 

Specifically, treatment with donanemab slowed decline by 32 percent compared to placebo at 76 weeks. And 40 percent of participants treated with the drug achieved amyloid negativity as early as six months after starting treatment, while 68 percent achieved this target by 18 months.

FDA granted breakthrough therapy designation for donanemab at the end of June.

"We are excited about the chance to work with Lilly in the effort to find an effective Alzheimer's prevention therapy as soon as possible, introduce novel ways to increase the size, speed, and ease of participating in Alzheimer's prevention trials, and do so in ways that might benefit the entire field," Eric M. Reiman, MD, Banner Alzheimer's Institute executive director and one of the study's lead principal investigators, said in the recent announcement.