Lilly says Alzheimer's drug slows clinical decline in mid-stage trial

Modesto Morganelli
Gennaio 14, 2021

Results from this trial - TRAILBLAZER-ALZ - showed that patients with early symptomatic Alzheimer's treated with donanemab experienced a "significant slowing of decline in a composite measure of cognition and daily function".

The two-year study, which has now concluded its second phase before entering a third and final phase, found patients' decline was slowed by as much as 32 per cent over 18 months - a reduction researchers described as "statistically significant".

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.

Both therapies focus on beta amyloid, which has been a somewhat controversial target for drug developers trying to figure out how best to treat people with Alzheimer's disease.

Patients in the study stopped receiving monthly infusions of the drug and were switched to a placebo once their brain plaques reached levels seen in healthy people - a process that took just a few months for some.

By targeting N3pG beta-amyloid, using donanemab has been shown to rapidly result in high levels of amyloid plaque clearance, according to Eli Lilly.

Skovronsky added that the results also "tell us that there are other things at play", revealing that further strategies were needed to completely fight off Alzheimer's.

The safety profile of donanemab was consistent with observations from Phase I data. Amyloid-related imaging abnormalities (ARIA) were observed. In the donanemab treatment group, amyloid-related imaging abnormalities - edema (ARIA-E) occurred in 27 percent of treated participants, with an overall incidence of 6 percent experiencing symptomatic ARIA-E.

Eli Lilly has recently proved that donanemab, an investigational treatment for Alzheimer's disease, slowed the disease progress in a phase-2 study. The trial enrolled 272 patients who were selected based on cognitive assessments in conjunction with amyloid plaque imaging and tau imaging.

Full results of TRAILBLAZER-ALZ will be presented at a future medical meeting and submitted to a peer-reviewed clinical journal, Lilly said. Lilly also plans to discuss these results with regulators as it assesses its next steps for donanemab.

"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.

The announcement touched off a stock surge for Lilly, which saw its share price climb 13% in response to the news, rising to $188.59 as of 9:36 a.m. before dipping to 185.43 from Friday's close of $166.41, an 11% gain. The Lilly and Biogen drug candidates are in the same class of therapies. The drug met a main objective to slow decline in about 18 months.

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