BIOGEN AND EISAI REPORT DATA FROM LONG-TERM EXTENSION PHASE 1B STUDY OF INVESTIGATIONAL ALZHEIMER’S DISEASE TREATMENT ADUCANUMAB August 28, 2018
Data Includes Additional Analyses of Long-Term Extension Phase 1b Study With Titration Cohort at 36 Months and Fixed-Dose Cohorts at 48 Months
Aducanumab, an investigational treatment for mild cognitive impairment (MCI) due to Alzheimer’s disease (AD) and mild AD dementia. The study includes fixed dosing at 1, 3, 6 and 10 mg/kg as well as an arm with a titration regimen in which patients received a gradually increased dose of aducanumab until they reach a maximum dose of 10 mg/kg. The LTE cohorts were allocated across six dosing arms including: placebo switchers, 1 mg/kg switchers to 3 mg/kg, fixed doses (3 mg/kg, 6 mg/kg, 10 mg/kg) and titration.
The results for each dose arm are generally consistent with previous interim analyses. Amyloid plaque levels as measured by positron emission tomography (PET) continued to decrease in a dose- and time-dependent manner in patients from the titration cohort at 36 months and fixed-dose cohorts at 48 months.
Amyloid plaque levels in the 10 mg/kg fixed-dose at 48 months remained at a level considered below the quantitative cut point that discriminates between a positive and negative scan.
Analyses of exploratory clinical endpoints Clinical Dementia Rating Sum of Boxes (CDR-SB) and the Mini-Mental State Examination (MMSE) suggest a continued benefit on the rate of clinical decline over 36 months and 48 months, respectively.
Of the 185 patients dosed with aducanumab in the Phase 1b study, eight patients experienced more than one episode of ARIA-E. The majority of ARIA events occurred early in the course of treatment; they were typically mild radiographically (MRI), clinically asymptomatic and resolved or stabilized within 4-12 weeks, with most patients continuing treatment. In the Phase 1b LTE.
Teezer wrote:BIOGEN IDEC PRESENTS POSITIVE INTERIM RESULTS FROM PHASE 1B STUDY OF INVESTIGATIONAL ALZHEIMER’S DISEASE TREATMENT ADUCANUMAB (BIIB037) AT 2015 AD/PD™ CONFERENCE
Treatment with aducanumab produced a dose- and time-dependent reduction of amyloid plaque in the brain. Amyloid plaque is believed to play a key role in the development of the symptoms of AD. In exploratory analyses, a dose-dependent, statistically significant effect of slowing clinical decline was observed on the Mini Mental State Examination (MMSE) and Clinical Dementia Rating (CDR) scales.
“This is the first time an investigational drug for Alzheimer’s disease has demonstrated a statistically significant reduction on amyloid plaque as well as a statistically significant slowing of clinical impairment in patients with prodromal or mild disease,” said Alfred Sandrock, M.D., Ph.D., group senior vice president and chief medical officer at Biogen Idec. “Based on these results, we are advancing the aducanumab clinical program to Phase 3 with plans to initiate enrollment later this year.”
Summary from Business Insider
When the drug was tested at a high dose, it showed a 71% reduction in the plaque after 54 weeks compared to the control drug. Investors had been expecting a 30% reduction, according to TheStreet's Adam Feuerstein. These percentages are measured by the Clinical Dementia Rating the industry uses.