Release date: 2017-11-06 Biogen will present new data from the company's research-based therapy aducanumab in the Phase 1b long-term extension (LTE) study at the Alzheimer's Disease (AD) Clinical Trial (CTAD) conference in Boston. AD is a neurodegenerative disease characterized by cognitive decline and behavioral disorders that ultimately lead to inability to perform daily activities. According to 2010 statistics, there are approximately 25 million AD patients worldwide. There is evidence that the pathological changes have begun before the disease has been clinically diagnosed for many years. As AD disease progresses, related cognitive impairments, behavioral changes, and dysfunction begin to emerge. Aducanumab (BIIB037) is a new drug being developed by Biogen for the treatment of early AD, which is obtained using Neumumune's RTM (Reverse Translational Medicine) technology platform. The researchers compared B-cell libraries from healthy elderly subjects with no cognitive impairment and obsessive elderly subjects with abnormally slow cognitive decline, and then obtained aducanumab human recombinant monoclonal antibodies. The innovative drug targets the beta-amyloid in the form of aggregates, selectively binds to amyloid plaques in the brain, and then clears the deposited proteins out of the brain by activating the immune system. Biogen's Phase 1b clinical trial is a randomized, double-blind, placebo-controlled, multi-dose trial designed to assess the safety and tolerability of aducanumab in patients with symptomatic or mild Alzheimer's disease. , pharmacokinetics, pharmacodynamics and clinical effects. The study included fixed doses of 1, 3, 6, and 10 mg/kg, as well as a titration group in which the dose of aducanumab was gradually increased until the highest dose of 10 mg/kg was reached. Of the 196 patients who completed the 54-week Phase 1b study, 143 chose to participate in LTE. All patients were treated with aducanumab in LTE. The level of amyloid plaques was measured by the standard uptake value ratio (SUVR) of positron emission tomography (PET). The Clinical Dementia Rating (CDR-SB) and Small Mental State Examination (MMSE) are the exploratory endpoints of Phase 1b studies, measuring cognitive and physical functions that may be affected by Alzheimer's disease. These assessments indicate that clinical improvement can be sustained in the second year of treatment with aducanumab. Related reading: Nature cover Xiong: Immunotherapy is expected to overcome Alzheimer's disease (Source: Nature) The estimated mean dose of the patient receiving the titration treatment at 24 months was 7.6 mg/kg. The study showed that the mean change in amyloid plaque levels was -0.170 in patients who switched from placebo to aducanumab after 12 months, and from 1 mg/kg to 3 mg/kg at 12 months - 0.149, 3 mg/kg was -0.197 in the treatment group, -0.280 in the 6 mg/kg treatment group, -0.322 in the 10 mg/kg treatment group, and -0.271 in the titration treatment group. The average reduction of CDR-SB scores in the above 6 groups at 24 months were 3.25, 3.52, 2.32, 2.98, 1.69, 2.65, respectively. The average reduction of MMSE for the above six groups was 4.28, 3.65, 2.81, 5.20, 1.97, and 1.95. The relevant data at 36 months also showed a sustained dose and time dependence reduction in amyloid plaque levels measured by SUVR using PET. Amyloid plaque levels reached and maintained a level below the quantitative cut point in the 10 mg/kg fixed-dose treatment group, and positive and negative differences were found during the scan. At 36 months, the mean change in amyloid plaque levels from placebo to 3 mg/kg or 3-6 mg/kg at 12 months was -0.226, and the 3 mg/kg treatment group was -0.208, -0.243 in the 6 mg/kg treatment group, -0.286 in the 10 mg/kg treatment group, and -0.160 in the titration treatment group. The average reduction of the CDR-SB scores of the above five groups were 5.28, 6.11, 3.86, 4.49, 2.84, respectively. The average reductions of the MMSE scores of the above five groups were 7.98, 6.35, 4.83, 8.97, and 4.10, respectively. ▲ Dr. Alfred Sandrock, Executive Vice President and Chief Medical Officer of Biogen (Source: Biogen Official Website) “We now have a 3-year study of aducanumab in Phase 1b clinical trials, during which we continued to observe a reduction in biomarker amyloid plaques,†said Dr. Alfred Sandrock, Executive Vice President and Chief Medical Officer of Biogen. "The results of the study also showed that the Phase 1b study showed a clinically declining efficacy in patients, especially in patients receiving the highest dose of aducanumab. Our Phase 3 clinical study of aducanumab is ongoing to determine if it is possible to treat early Ara. Zhaimer disease." We look forward to the successful development of this new drug in Phase 3 clinical trials. Meet patients early to improve the elderly life of the elderly. Reference materials: [1] Biogen's Early-Stage Alzheimer's Data Continues to Impress [2] Biogen Presents New Data from Long-Term Extension of Phase 1b Study of Investigational Alzheimer's Disease Treatment Aducanumab [3] WuXi PharmaTech WeChat Public Account - The long-awaited clinical results of Biogen Alzheimer's disease are freshly released Source: WuXi PharmaTech Canned Fruit Mix, Canned Fruit Cocktail NSA, Canned Mixed Fruits in Sucralose, Canned Fruit Mix No Sugar Added, Cherry Mixed Fruits in Splenda ZHEJIANG FOMDAS FOODS CO., LTD. , https://www.fomdasfoods.com