Full phase 2 data of Lilly's donanemab for Alzheimer's offers mixed bag

Mar. 13, 2021 9:20 AM ETEli Lilly and Company (LLY), SAVALLY, SAVABy: Jonathan Block, SA News Editor41 Comments
  • Full data released today from Eli Lilly's (NYSE:LLY) phase 2 TRAILBLAZER-ALZ trial of donanemab in Alzheimer's disease reinforced previously released top-line data that the monoclonal antibody (mAb) slowed cognitive decline in patients with early symptoms of the disease.
  • However, results for most secondary outcomes, such as improvement in scores between treatment and placebo groups on the Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB) and the 13-item Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog13), showed "no substantial difference."
  • Results were presented today at the 2021 International Conference on Alzheimer's and Parkinson's Diseases (AD/PD 2021) and also published in The New England Journal of Medicine.
  • "The use of donanemab resulted in a better composite score for cognition and for the ability to perform activities of daily living than placebo at 76 weeks, although results for secondary outcomes were mixed," the researchers wrote in the medical journal.
  • At 76 weeks, donanemab, a mAb that targets beta amyloid, a brain plaque thought to contribute to the progression of Alzheimer's, slowed cognitive decline by 32% compared to placebo, based on the Integrated AD Rating Scale (iADRS) which was statistically significant. This was the primary endpoint.
  • Also, 40% of participants treated with donanemab achieved amyloid negativity as early as six months after starting treatment, and 68% by 18 months.
  • The study enrolled only 272 people, so Lilly will likely have to follow-up with a much larger trial to have a good chance at winning FDA approval.
  • Safety, tolerability and efficacy of donanemab are also being evaluated in another phase 2 study, TRAILBLAZER-ALZ 2.
  • In a Seeking Alpha commentary yesterday, author Edmund Ingham of Haggerston BioHealth wrote that "donanemab is Lilly's major price catalyst - for downside and upside - so investors may wish to wait for results before making an investment decision," adding that interim phase 3 data should be available later this year.
  • In February, Cassava Sciences (NASDAQ:SAVA) released positive interim data from an open-label study of its lead Alzheimer's candidate, simufilam.
  • Lilly shares closed Friday up 1.4% to $208.08.

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