- The stock price of Eli Lilly and Company (NASDAQ: LLY) increased over 5% this past week as it went from a stock price of $166.72 as of January 6 morning to $179.23 (as of 2:05 PM ET today). This is why it happened.
The stock price of Eli Lilly and Company (NASDAQ: LLY) increased over 5% this past week as it went from a stock price of $166.72 as of January 6 morning to $179.23 (as of 2:05 PM ET today). One of the biggest reasons for the surge in stock price has to do with an announcement about their experimental Alzheimer’s drug.
Yesterday, Eli Lilly had announced that its experimental Alzheimer’s drug significantly slowed the rate of decline in trial patients. Donanemab — which is an investigational antibody that targets a modified form of beta amyloid called N3pG — had showed significant slowing of decline in a composite measure of cognition and daily function in patients with early symptomatic Alzheimer’s disease compared to placebo in results from the company’s Phase 2 TRAILBLAZER-ALZ study. And donanemab met the primary endpoint of change from baseline to 76 weeks in the Integrated Alzheimer’s Disease Rating Scale (iADRS), slowing decline by 32% relative to the placebo — which was statistically significant.
The iADRS is a clinical composite tool combining the cognitive measure ADAS-Cog13 and functional measure ADCS-iADL, two commonly used measures in Alzheimer’s disease. And donanemab also showed consistent improvements in all prespecified secondary endpoints measuring cognition and function compared to placebo, but did not reach nominal statistical significance on every secondary endpoint.
By targeting N3pG beta amyloid, donanemab treatment showed to rapidly result in high levels of amyloid plaque clearance, as measured by amyloid imaging. And 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). In the study, 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.
The safety profile of donanemab was consistent with observations from Phase 1 data. And amyloid-related imaging abnormalities (ARIA) were observed — which is consistent with amyloid plaque clearing antibodies. In the donanemab treatment group, amyloid-related imaging abnormalities – edema (ARIA-E) occurred in 27% of treated participants, with an overall incidence of 6% experiencing symptomatic ARIA-E.
“We are extremely pleased about these positive findings for donanemab as a potential therapy for people living with Alzheimer’s disease, the only leading cause of death without a treatment that slows disease progression. We look forward to discussing the TRAILBLAZER-ALZ study data and next steps with global regulators. In addition, we are committed to reproducing and extending these important findings in our second ongoing pivotal donanemab trial, TRAILBLAZER-ALZ 2. With more than 30 years of dedication to finding solutions for this devastating disease, we are proud of our progress moving the field forward and advancing the science. These positive results give us hope for patients and their families.”
— Mark Mintun, M.D., vice president of pain and neurodegeneration, Eli Lilly and Company
“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. 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. The positive results we have obtained today give us confidence in donanemab and support its rapid and deep plaque clearance for the potential treatment of Alzheimer’s disease.”
— Daniel Skovronsky, M.D., Ph.D., Lilly’s chief scientific officer and president of Lilly Research Laboratories
Disclosure: I have a small LLY position in my stock portfolio.