Eli Lilly has entered a strategic research partnership with Banner Alzheimer’s Institute to conduct the planned Phase III TRAILBLAZER-ALZ 3 clinical trial of donanemab to prevent the progression of Alzheimer’s disease.
Donanemab is an experimental antibody designed to act on an altered beta-amyloid form called N3pG. In the Phase II TRAILBLAZER-ALZ trial, the drug was able to slow the decline in Alzheimer’s patients by 32% at 76 weeks versus baseline.
The randomised, placebo-controlled Phase III trial will assess the drug in patients at risk of cognitive and functional decline associated with Alzheimer’s.
It will test donanemab’s ability to slow the clinical progression of the disease in individuals with Alzheimer’s pathology but no clinical symptoms.
Under the partnership, Banner will use its capabilities and experience in Alzheimer’s prevention trials to support the enrolment of subjects with and without the e4 type of the apolipoprotein E (APOE4) gene.
The trial enrolment will occur via the Alzheimer’s Prevention Registry’s GeneMatch programme.
This is intended to facilitate a more virtual method of assessing preventive treatments for the disease.
Lilly and Banner agreed to leverage the screening and treatment data as a shared scientific resource. Meanwhile, Lilly will exclusively fund the trial with enrolment planned for later this year.
Eli Lilly pain and neurodegeneration vice-president Mark Mintun 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 healthcare community to find potential treatments to end this devastating disease.
“While these types of trials are challenging to enrol 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.”
Lilly is also testing donanemab in the Phase III TRAILBLAZER-ALZ 2 clinical trial, which is ongoing in early, symptomatic Alzheimer’s patients. It includes subjects with memory loss that worsened over the past six months or more.