Donanemab, an investigational antibody developed by Eli Lilly, has demonstrated positive results in a phase IIa trial in patients with early-stage Alzheimer’s disease (AD).
The phase IIa TRAILBLAZER-ALZ study is evaluating donanemab in patients with early symptomatic AD.
In the mid-stage trial, Lilly’s anti-amyloid antibody showed a significant slowing of decline in cognition and daily function in this patient population.
Donanemab also demonstrated ‘consistent improvements’ in all secondary endpoints measuring cognition and function compared to placebo, although it did not reach statistical significance on every secondary endpoint.
“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,” said Mark Mintun, vice president of pain and neurodegeneration, Eli Lilly.
“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,” he added.
Donanemab targets a modified form of beta amyloid called N3pG. By targeting N3pG, donanemab has been shown to result in high levels of amyloid clearance, according to Lilly.
In the TRAILBLAZER-ALZ trial, patients treated with donanemab showed an 84 centiloid reduction of amyloid plaque, on average, at 76 weeks, compared to a baseline of 108 centiloids.
Patients stopped receiving donanemab and switched to placebo after their plaque level was below 25 centiloids for two consecutive measures, or below 11 centiloids at any one measure – less than 25 centiloids is ‘typical’ of a negative amyloid scan, added Lilly.