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Biogen Presents Data from Phase 1b Study of Investigational Alzheimer's Disease Treatment Aducanumab at 2016 Clinical Trials on Alzheimer's Disease MeetingBiogen (NASDAQ: BIIB) announced it will present new data from the Phase 1b (PRIME) study of aducanumab, its investigational treatment for early Alzheimer's disease (AD), today at the 9th Clinical Trials on Alzheimer's Disease (CTAD) meeting in San Diego. Data presentations include interim results from the titration cohort of the placebo-controlled period of the Phase 1b study as well as data from the first year of the long-term extension (LTE (News - Alert)). The results support the ongoing Phase 3 studies of aducanumab for early AD. "The data at CTAD support the positive results we have seen in our Phase 1b study of aducanumab, and they provide insight into the observed effects in patients treated for up to two years," said Samantha Budd Haeberlein, vice president, clinical development at Biogen. "We are committed to advancing our global Phase 3 program for aducanumab as well as the scientific understanding of Alzheimer's disease so we can help identify a treatment for the many people affected by this terrible disease."
Phase 1b Study The Phase 1b study includes fixed dosing at 1 (n=31), 3 (n=33), 6 (n=30) and 10 mg/kg (n=32) as well as an arm with a titration regimen (n=23) and pooled placebo (n=48). Phase 1b also includes an LTE for patients who completed the one-year placebo-controlled portion of the study. The aducanumab data presented at CTAD are consistent with previously reported analyses from this study.
12-Month Titration Arm In order to explore the potential effect of titrating aducanumab, ApoE4-carrier patients were enrolled in the titration arm and titrated aducanumab up to 10 mg/kg (n=23). The incidence of ARIA-E in ApoE4 carriers in the fixed-dose arms was 5 percent in the 1 mg/kg and 3 mg/kg arms, 43 percent in the 6 mg/kg arm and 55 percent in the 10 mg/kg arm. The incidence of ARIA-E in ApoE4 carriers in the titration arm was 35 percent. At 54 weeks, a statistically significant reduction of amyloid plaque (versus placebo) was observed in all fixed-dose arms: 1 mg/kg [-0.050 (p<0.05)], 3 mg/kg [-0.130 (p<0.001)], 6 mg/kg [-0.206 (p<0.001)], 10 mg/kg [-0.263 (p<0.001)] and in the titration arm [-0.171 (p<0.001)]. The standardized uptake value ratio1 was virtually unchanged in the placebo group at 54 weeks. Results from exploratory endpoints, Clinical Dementia Rating sum of boxes (CDR-SB) and the Mini-Mental State Examination (MMSE), were also presented. The results of the CDR-SB showed that patients in the placebo group worsened by an average of 1.89 points at 54 weeks compared with the following treatment arms:
The results of the MMSE showed that patients in the placebo group worsened by an average of 2.45 points at 52 weeks. Average clinical decline on the MMSE in the treatment arms was:
Patients who completed the 54-week, placebo-controlled period of Phase 1b had the option to continue in the LTE. Patients who were randomized to placebo or aducanumab 1 mg/kg in the placebo-controlled period were switched to aducanumab 3 mg/kg or to a 3 - 6mg/kg titration regimen in the LTE. Patients randomized to aducanumab 3, 6 or 10 mg/kg or titration in the placebo-controlled period continued in the same dose group in the LTE. In the LTE, there were no new cases of ARIA-E in patients initially randomized to aducanumab 3, 6 or 10 mg/kg who were treated up to 24 months. The incidence of ARIA-E in patients switching from placebo to aducanumab was consistent with the incidence reported in placebo-controlled portion of Phase 1b. Analyses of exploratory endpoints from the first 12 months of the LTE study suggest patients treated with aducanumab for up to 24 months (n=69) continued to have beneficial effects on the reduction of amyloid plaque and the rate of clinical decline as measured by CDR-SB and MMSE.
Aducanumab Data Presentations at CTAD
Phase 3 Clinical Studies For more information about the Phase 3 studies, including information about participating centers, visit www.ClinicalTrials.gov (NCT02477800 or NCT02484547).
About Aducanumab Aducanumab is thought to target aggregated forms of beta amyloid including soluble oligomers and insoluble fibrils which can form into amyloid plaque in the brain of AD patients. Based on pre-clinical and Phase 1b data to date, treatment with aducanumab has been shown to reduce amyloid plaque levels. In August 2016 aducanumab was accepted into the EMA's (News - Alert) PRIME program. In September 2016 the U.S. FDA accepted aducanumab into its Fast Track program.
About Alzheimer's Disease
About Biogen
Biogen Safe Harbor 1 A composite standardized uptake value ratio (SUVR) of six regions of the brain - frontal, parietal, lateral temporal, sensorimotor, anterior and posterior cingulate - was calculated at baseline, at 26 weeks and at 54 weeks using whole cerebellum as a reference. 2 World Health Organization Dementia a Public Health Priority. http://www.who.int/mental_health/publications/dementia_report_2012/en/. Accessed 23 May 2016. View source version on businesswire.com: http://www.businesswire.com/news/home/20161208006320/en/ |