According to results from the Phase 3 TRAILBLAZER-ALZ 2 study published in JAMA, the monoclonal antibody donanemab significantly slowed cognitive and functional decline in patients with early symptomatic Alzheimer’s disease by approximately 35% at one year compared to placebo. The trial enrolled 1736 patients across 277 research centers in 8 countries.
Another monoclonal antibody, Leqembi (lecanemab) recently won FDA approval for Alzheimer’s disease treatment after showing a statistically significant 27% reduction in decline on the Clinical Dementia Rating Scale in trials.
Donanemab is an investigational plaque-clearing antibody similar to lecanemab and aducanumab, which controversially notched FDA approval in 2021 based on its plaque reduction despite inconsistent clinical efficacy data.
A look at TRAILBLAZER-ALZ 2
The Phase 3 TRAILBLAZER-ALZ 2 study demonstrated that donanemab, an investigational drug, significantly slowed cognitive and functional decline in patients with early symptomatic Alzheimer’s disease. The measured decline in iADRS and CDR-SB scores over 76 weeks was less severe in patients treated with the drug candidate compared to those given a placebo. On the iADRS scale, where lower scores indicate greater impairment, patients treated with donanemab showed a decline of 6.02 points versus a 9.27 point decline in the placebo group. These results suggest that donanemab could potentially be an effective treatment for slowing the progression of Alzheimer’s disease symptoms.
Aducanumab has failed to generate material sales. According to Evaluate, donanemab is expected to reach peak sales of around $6 billion by 2026. Donanemab reduced amyloid plaque by 84% on average and allowed discontinuation of dosing after plaque clearance for most patients by 12-18 months.
Regulatory submissions for donanemab are complete, with decisions expected by end of 2023. The monoclonal antibody provided a 39% lower Alzheimer’s progression risk over 18 months, equating to more than 7.5 additional months on average before clinical decline levels of placebo patients.
Filed Under: Brain Breakthroughs, clinical trials, Drug Discovery, Neurological Disease