Lilly Alzheimer’s Candidate Donanemab Shows Positive Phase II Data
Updated: Jan 14
Eli Lilly today released topline Phase II data showing that its modified beta amyloid-targeting antibody donanemab significantly slowed decline in a composite measure of cognition and daily function in patients with early symptomatic Alzheimer’s disease compared to placebo.
According to the data, from Lilly’s TRAILBLAZER-ALZ study (NCT03367403), donanemab met the primary endpoint of change from baseline to 76 weeks in the Integrated Alzheimer’s Disease Rating Scale (iADRS), slowing decline by a statistically significant 32% compared with placebo.
Donanemab also showed consistent improvements in all pre-specified secondary endpoints measuring cognition and function compared to placebo, but did not reach nominal statistical significance on every secondary endpoint, Lilly said.
By targeting N3pG beta amyloid, Lilly said, donanemab treatment showed itself to rapidly result in high levels of amyloid plaque clearance, as measured by amyloid imaging. In TRAILBLAZER-ALZ, donanemab-treated patients, on average, showed an 84 centiloid reduction of amyloid plaque at 76 weeks compared to a baseline of 108 centiloids (less than 25 centiloids is typical of a negative amyloid scan).
Patients stopped receiving donanemab and switched to placebo once their plaque level was below 25 centiloids for two consecutive measures or below 11 centiloids at any one measure.
“This unique mechanism and antibody for clearing plaques, discovered at Lilly, has the potential to provide high levels of durable amyloid plaque clearance after limited duration dosing,” Daniel Skovronsky, MD, PhD, Lilly’s chief scientific officer and president of Lilly Research Laboratories, said in a statement. “In conjunction with our expertise in amyloid and tau imaging, this allowed us to conduct a trial to test if reducing amyloid plaques in Alzheimer’s patients to levels seen in scans of healthy individuals could result in clinically meaningful slowing of cognitive decline.
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