Today, Japanese drug developer Eisai, and Biogen Inc. announced positive topline results from Eisai’s large-scale Phase 3 trial which demonstrated that lacanemab, an investigational therapy, reduced mild cognitive decline (MCI) in patients with Alzheimer’s disease (AD).
The placebo-controlled, double-blind, parallel-group study, called Clarity AD, comprised of nearly 1,800 people with early AD, and took place across Japan, the U.S., and Europe. The population of interest were randomized 1:1 to receive either a placebo or 10 mg of lacanemab bi-weekly for 18 months. Patients with a broad range of comorbidities, such as hypertension, diabetes, renal disease, and obesity, were all permitted to enroll. The trial investigators were also cognizant of inclusion; a quarter of the study subjects were either African American or Hispanic.
The results demonstrated that lecanemab treatment met the primary endpoint, which was defined as a change from baseline according to the Clinical Dementia Rating-Sum of Boxes (CDR-SB) at the conclusion of treatment. Specifically, laceanemab reduced clinical cognitive decline by 27% compared with placebo. The researchers observed marked clinical changes as early as six months.
Moreover, the study met all of its key secondary endpoints, which were stipulated as change from baseline at 18 months with respect to treatment of amyloid levels in the brain measured by amyloid positron emission tomography (PET), the AD Assessment Scale-cognitive subscale14 (ADAS-cog14), AD Composition Score (ASCOMS), and the AD Cooperative Study-Activities of Daily Living Scale for Mild Cognitive Impairment (ADCS MCI-ADL).
“Today’s announcement gives patients and their families hope that lecanemab, if approved, can potentially slow the progression of Alzheimer’s disease, and provide a clinically meaningful impact on cognition and function,” said Michel Vounatsos, Chief Executive Officer at Biogen via a press release. “Importantly, the study shows that removal of aggregated amyloid beta in the brain is associated with a slowing of disease in patients at the early stage of the disease. We want to thank the many patients who participated in this groundbreaking global study and want to acknowledge the clinical investigators who worked tirelessly to increase the enrollment of traditionally underrepresented populations. As pioneers in neuroscience, we believe defeating this disease will require multiple approaches and treatment options, and we look forward to continuing the discussion about the significance of these findings with the patient, scientific, and medical communities.”
The U.S. Food and Drug Administration (FDA) accepted Eisai’s Biologics License Application (BLA) for lacenemab under the accelerated approval pathway and granted it Priority Review back in July. According to the press release, the FDA has agreed that the results of Clarity AD verifies the clinical benefit of lacenemab in the treatment of AD.