/p>The companies Eisai Co.,Ltd. and Biogen Inc. have announced positive results in the phase II study with BAN2401a anti-amyloid-beta protofibril antibodyin which they have participated 856 patients with Alzheimer’s disease early onset.
The study has reached statistical significance in the predefined primary objectives that assess the Efficacy 18 months after slowing down progression on the Alzheimer’s disease composite score (ADCOMS) and the reduction of accumulated amyloid in the brainas measured by amyloid PET (positron emission tomography).
Study 201 is a randomized, parallel group, double-blind, placebo-controlled study conducted in 856 patients with mild cognitive impairment (MCI) due to Alzheimer’s disease or mild dementia of the Alzheimer’s type (known as early-onset Alzheimer’s disease) with confirmed amyloid pathology in the brain.
Efficacy was assessed at 18 months using standard predefined statistics of the ADCOMS score, which combines items from the Alzheimer’s Disease Assessment Scale Cognitive Subscale (ADAS-Cog), the sum of boxes from the Alzheimer’s Disease Rating Scale dementia (CDR-SB) and the Mental State Examination (MMSE) to allow the Sensitive detection of changes in Alzheimer’s disease symptoms early onset.
The first level results of the final analysis of the study demonstrated a statistically significant slowing of disease progression on the key endpoint (ADCOMS) after 18 months of treatment in patients receiving the highest dose (10 mg/kg twice weekly), compared to placebo.
Results of amyloid PET analysis at 18 months, including reduction in amyloid PET standardized uptake ratio (SUVR) and visual reading of amyloid PET images with patients who have gone from positive to negative values of amyloid in the brainwere also statistically relevant with this dosage regimen.
They were also observed Dose-related changes from baseline in PET results and clinical endpoints. Besides, the highest treatment dose with BAN2401 began to show clinical benefits statistically significant as measured by the ADCOMS score from 6 months and even after 12 months.
BAN2401 showed an acceptable tolerability profile during the 18 months in which the study drug was administered. The most common treatment-emergent adverse events were infusion-related reactions and amyloid-related imaging abnormalities (ARIA).
The infusion-related reactions were mostly mild to moderate in intensitywhile the incidence of ARIA-E (edema) did not exceed 10% in either treatment groupand it was less than 15% in patients with APOE4 who were administered the highest dose, according to the safety and notification procedures of the study protocol2.
The detailed results of the study of and they showed up at the AAIC (Alzheimer’s Association International Conference) in Chicago on July 25. «18-month results from trial with BAN2401 are impressive and they suppose a very important support for the amyloid hypothesis«it states Jeff Cummingsphysician, founding director, Cleveland Clinic Lou Ruvo Center for Brain Health. “It is my hope that the dataset will be shared with the broader Alzheimer’s disease community and contribute to the fight against this devastating disease.”indicates this expert.
for dr. lynn kramerclinical director and medical director of Neurology Business Group, Eisai, “This is the first late-stage study with anti-amyloid antibodies that has obtained statistically significant results at 18 months, which validates the amyloid hypothesis. VWe are going to discuss these very encouraging results with regulatory authorities to determine the best way forward. We continue to work with objective of being able to supply BAN2401 to patients and healthcare professionals as soon as possible”.
“The prospect of being able to offer a disease modifying therapy relevant to those people who suffer from this terrible disease is something as exciting as it is instructive”it states Alfred Sandrockphysician, doctor, executive vice president and chief medical officer of Biogen. “These 18-month data from BAN2401 offer relevant insights into the investigation of potential treatment options for patients with Alzheimer’s disease and highlights that treatment of neurodegenerative diseases may not be as unfeasible as it once seemed«he concludes.
This information is based on experimental use of an agent in development and is not intended to state any conclusions about efficacy or safety. There is no guarantee that any experimental use of this product will successfully complete clinical development or achieve regulatory approval.