BioArctic’s partner Eisai has announced results for the large global Phase 3 confirmatory Clarity AD study in 1,795 subjects.
The study met the primary endpoint showing a highly statistically significant reduction of clinical decline. All key secondary endpoints were also met demonstrating highly statistically significant results, describes the company in a press release.
Eisai will discuss this data with regulatory authorities in the U.S., Japan and Europe with the aim to file for traditional approval in the US and for marketing authorization applications in Japan and Europe by the end of the first quarter of 2023.
“We are proud that our founder Lars Lannfelt’s discoveries has the potential to fundamentally improve the treatment of Alzheimer’s disease, where there currently are very limited options.”
“This is a huge accomplishment by our employees and our partner Eisai who have worked tirelessly for almost two decades to make this project a success. We are proud that our founder Lars Lannfelt’s discoveries has the potential to fundamentally improve the treatment of Alzheimer’s disease, where there currently are very limited options,” said BioArctic’s CEO Gunilla Osswald in the press release. “The results are also a confirmation of our technology platform and strengthens our hope to also be able to help improve the treatment of other neurodegenerative diseases such as Parkinson’s disease, ALS and others.”
About Clarity AD
Clarity AD is a clinical trial of lecanemab, an investigational anti-amyloid beta (Aβ) protofibril antibody for the treatment of mild cognitive impairment (MCI) due to Alzheimer’s disease (AD) and mild AD (collectively known as early AD), with confirmed presence of amyloid pathology in the brain.
The relative risk in Clarity AD of the main side effect associated with anti-amyloid therapies, ARIA, was within expectations.
Photo of Gunilla Osswald, CEO, BioArctic (left) and illustration of Alzheimer’s disease – neurons with amyloid plaques (right)