Eli Lilly’s experimental Alzheimer’s drug, donanemab, has been shown to significantly slow cognitive and functional decline in patients with early-stage disease.

The phase 3 TRAILBLAZER-ALZ 2 study met its primary endpoint, with the drug slowing the progression of the disease by 35% compared to placebo in 1,182 patients with early symptomatic Alzheimer's disease and intermediate levels of tau protein.

All secondary endpoints of cognitive and functional decline were also met and showed highly statistically significant clinical benefits, the company said.

Results from the trial demonstrated that 47% of patients who received donanemab showed no disease progression a year after starting treatment, compared with 29% on placebo.

Additionally, 52% of patients completed their course of treatment by one year, and 72% completed by 18 months as a result of achieving amyloid plaque clearance.

Patients receiving donanemab also experienced a 39% lower risk of progressing to the next stage of disease, and those in the treatment group had 40% less decline in their ability to perform activities of daily living at 18 months.

Daniel Skovronsky,Lilly's chief scientific and medical officer, and president of Lilly Research Laboratories, said: "We are extremely pleased that donanemab yielded positive clinical results with compelling statistical significance for people with Alzheimer's disease in this trial.

“This is the first phase 3 trial of any investigational medicine for Alzheimer's disease to deliver 35% slowing of clinical and functional decline."

In addition to slowing cognitive and functional decline, donanemab produced significant reductions in brain amyloid plaque levels as early as six months after initiating treatment.

Based on these results, Lilly said it will proceed with global regulatory submissions 'as quickly as possible' and anticipates making a submission to the US Food and Drug Administration (FDA) in this quarter of 2023.

In January, Lilly announced that donanemab had been denied accelerated approval by the FDA due to the company not submitting enough trial data from patients with at least 12 months of drug exposure.

In a complete response letter, the FDA specifically requested that the company provide data from at least 100 patients who received a minimum of 12 months of continued treatment with donanemab.

Reference：

https://www.pmlive.com/pharma_news/eli_lillys_alzheimers_drug_shown_to_significantly_slow_disease_progression_in_phase_3_trial_1491300