2023-05-03 07:13:53 ET
Eli Lilly's ( NYSE: LLY ) Alzheimer's drug donanemab met the main and secondary goals of a phase 3 trial as the drug slowed cognitive and functional decline in people with early symptomatic Alzheimer's disease (AD).
Lilly expects to file an application with the U.S. Food and Drug Administration (FDA) this quarter and will work with the FDA and other global regulators to achieve the fastest path to traditional approvals, the company added.
The late-stage study, dubbed TRAILBLAZER-ALZ 2, evaluated donanemab versus placebo in people with early symptomatic AD, which includes mild cognitive impairment (MCI) and the mild dementia stage of disease.
The main goal measured via the Alzheimer's Disease Rating Scale (iADRS) measures cognition and activities of daily living such as managing finances, driving, engaging in hobbies, and conversing about current events.
In the primary analysis population (n=1182), the main goal (iADRS) showed 35% slowing of decline, compared to placebo.
Meanwhile, an important secondary goal (Clinical Dementia Rating-Sum of Boxes (CDR-SB) - a measure of disease severity) showed 36% slowing of decline over 18 months.
Lilly said 47% of people on donanemab showed no decline on CDR-SB, compared to 29% on placebo, at 1 year.
People on donanemab had 40% less decline in ability to perform activities of daily living, at 18 months.
In addition, people on donanemab experienced a 39% lower risk of progressing to the next stage of disease, compared to placebo.
About 52% of people completed their course of treatment by 1 year and 72% by 18 months due to achieving plaque clearance, the company noted.
"This is the first Phase 3 trial of any investigational medicine for Alzheimer's disease to deliver 35% slowing of clinical and functional decline," said Daniel Skovronsky, Lilly's chief scientific and medical officer, and president of Lilly Research Laboratories.
The company noted that donanemab produced significant reductions in brain amyloid plaque levels as early as 6 months after starting treatment.
In addition, Lilly said that trial also enrolled a smaller number of people with high levels of tau at baseline (n=552).
Data from the high tau people combined with the intermediate tau population (n=1736), showed that donanemab demonstrated positive results, with CDR-SB and iADRS showing 29% and 22% slowing of decline, respectively, according to Lilly.
Safety data :
The company said that incidence of amyloid-related imaging abnormalities (ARIA) was consistent with a phase 2 trial, dubbed TRAILBLAZER-ALZ.
Temporary swelling in areas of the brain (ARIA-E), occurred in 24% of people in the overall donanemab treatment group, with with 6.1% experiencing symptomatic ARIA-E.
Meanwhile, microhemorrhages or superficial siderosis (ARIA-H), occurred in 31.4% in the donanemab group and 13.6% in the placebo group.
The incidence of serious ARIA was 1.6%, including two people whose death was attributed to ARIA and a third patient who died after an incident of serious ARIA, the company added.
"We are encouraged by the potential clinical benefits that donanemab may provide, although like many effective treatments for debilitating and fatal diseases, there are associated risks that may be serious and life-threatening," said Mark Mintun, group vice president Neuroscience Research & Development at Lilly, and president of Avid Radiopharmaceuticals.
LLY +7.62% to $435.07 premarket May 3
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Lilly stock surges after Alzheimer's drug donanemab slows cognitive decline by 35%, brain swelling seen in some