Breaking News
January 15, 2019 - AHA: New Cholesterol Guidelines Put Ethnicity in the Spotlight
January 15, 2019 - Different brain areas linked to smoking and drinking
January 15, 2019 - Henry Marsh shares insights into neurosurgery and more at Dean’s Lecture Series
January 15, 2019 - Want to Live Longer? For Just 30 Minutes a Day, Do Anything Else But Sit
January 15, 2019 - The Current issue of “The view from here” is concerned with Targets
January 15, 2019 - Plain packaging sparked tobacco price rises, new study finds
January 15, 2019 - Sedentary lifestyles can be unhealthy, physical activity can lower risk
January 15, 2019 - Gut microbiome may help prevent development of cow’s milk allergy
January 15, 2019 - Lesbian, gay and bisexual individuals more likely to suffer severe substance use disorders
January 15, 2019 - New England Journal of Medicine Publishes Positive Results of the Pivotal Trial of Cablivi (caplacizumab) for Rare Blood Clotting Disorder
January 15, 2019 - Levels of inflammatory marker (CRP) linked to housing type and tenure
January 15, 2019 - Three gifts I’m glad I gave myself in 2018
January 15, 2019 - Columbia’s Pediatrics Department Names New Vice Chairs, Expands Leadership
January 15, 2019 - US FDA Accepts Regulatory Submissions for Review of Tafamidis to Treat Transthyretin Amyloid Cardiomyopathy
January 15, 2019 - Staying fit can cut your risk of heart attack by half
January 15, 2019 - Vitamin D supplements are of no gain to those over 70, study shows
January 15, 2019 - Scientists create comprehensive new method to predict breast cancer risk
January 15, 2019 - Research shows connection between social media use and impaired risky decision-making
January 15, 2019 - FDA Approves Expanded Use of Adacel (Tdap) Vaccine for Repeat Vaccination
January 15, 2019 - Treating spinal pain with replacement discs made of ‘engineered living tissue’ moves closer to reality
January 15, 2019 - Providers Walk ‘Fine Line’ Between Informing And Scaring Immigrant Patients
January 15, 2019 - Outcomes Poorer for Medicaid Beneficiaries With STEMI
January 15, 2019 - Decorative Products on Foods Can Be Unsafe
January 15, 2019 - A dream of sustainable surgery in Uganda
January 15, 2019 - Study shows how herpes viruses and tumors have learned to manipulate the same ancient RNA
January 15, 2019 - Common Heart, Diabetes Meds May Help Ease Mental Illness
January 15, 2019 - Stress and trauma in earliest years linked to reduced hippocampal volume in adolescence
January 15, 2019 - Scientists identify endogenous activator of sigma-1 receptors in human cells
January 15, 2019 - MAR treatments unlikely to be cause of premature or low birth weight babies
January 15, 2019 - Parental CPTSD increases transmission of trauma to offspring of Tutsi genocide survivors
January 15, 2019 - High-fat diets shown to increase blood pressure
January 15, 2019 - New institute for food safety to be established in Netherlands
January 15, 2019 - Keele University researchers receive £2.4 million grant to help reduce overprescribing of opioids
January 15, 2019 - Synthetic compound reverses mutant p53 aggregate accumulation, study shows
January 15, 2019 - First elder care robot tested in a WSU smart home apartment
January 15, 2019 - Oxford researchers explore relationship between technology use and adolescent mental health
January 15, 2019 - From microbiome research to healthier and sustainable foods
January 15, 2019 - How coaching moms and dads improves infants’ language skills
January 15, 2019 - Precision health approach tapped to identify causes of poverty
January 14, 2019 - DNA origami can accurately measure how antibodies interact with several antigens
January 14, 2019 - Researchers identify multiple new subtypes of most common childhood cancer
January 14, 2019 - Total Fertility Rates Vary by State
January 14, 2019 - Elevated blood lead level in early childhood associated with increased risk of academic problems in school-aged children
January 14, 2019 - Superior technique identified that can block CRISPR gene editing
January 14, 2019 - Turning breast cancer cells into fat cells prevents the formation of metastases
January 14, 2019 - Review examines what influences HIV-positive patients to stay on antiretroviral drugs in Africa
January 14, 2019 - Identifying genetic factors that lead to squamous cell carcinoma
January 14, 2019 - Virtual video visits can replace office visits without compromising quality of care
January 14, 2019 - Health Highlights: Jan. 10, 2019
January 14, 2019 - Scientists uncover how protein clumps damage cells in Parkinson’s
January 14, 2019 - Physician-scientist’s “indomitable spirit” prevails over personal adversity
January 14, 2019 - King’s researchers receive £1.25 million to investigate fatal eating disorder
January 14, 2019 - UCR researchers uncover how plants sense temperature
January 14, 2019 - Scientists find link between colitis and colon cancer
January 14, 2019 - New skin patch provides long-acting contraceptive protection
January 14, 2019 - Asparagine synthetase deficiency – Genetics Home Reference
January 14, 2019 - Improved stem cell approach could aid fight against Parkinson’s
January 14, 2019 - New class of sleeping pill preserves ability to wake in response to danger signals
January 14, 2019 - Cancer patients are four times more likely to commit suicide
January 14, 2019 - The human brain works in reverse order to retrieve memories
January 14, 2019 - Simple tips can lead to better food choices
January 14, 2019 - Meth’s Resurgence Spotlights Lack Of Meds To Combat The Addiction
January 14, 2019 - TARA Biosystems and Insilico Medicine collaborate to discover novel therapies for cardiac disease
January 14, 2019 - Early life stress in mice affects their offspring behavior
January 14, 2019 - Depression Tied to Worse Asthma Outcomes in Urban Teens
January 14, 2019 - Santa calorie counting
January 14, 2019 - Opiod prescriptions for pet dogs misused by their masters
January 14, 2019 - People with ASD could be better at recognizing regret and relief in others finds study
January 14, 2019 - Conducting ChIP-Seq with Low Cell Numbers
January 14, 2019 - Study explores support and social networks of family carers of people with dementia
January 14, 2019 - At Risk for an Opioid OD? There’s an App for That
January 14, 2019 - Single national electronic health record will help improve care in Canadian hospitals
January 14, 2019 - Study unearths Britain’s first speech therapists
January 14, 2019 - Study reveals nuances of racial inequalities in breast cancer prevention
January 14, 2019 - Air pollution can raise the risk of miscarriage among women finds study
January 14, 2019 - An extra meal a day cuts deaths by half in elderly with hip fractures
January 14, 2019 - Researchers report vision-based neurotransmitter events for the first time
January 14, 2019 - Pharmacists could significantly reduce ED crowdedness
January 14, 2019 - PTSD linked with cardiovascular disease and cancer, study shows
January 14, 2019 - New analytic model can accurately predict patients at risk of developing PTSD
Biogen and Eisai announce results of LTE Phase 1b study of aducanumab for treating MCI

Biogen and Eisai announce results of LTE Phase 1b study of aducanumab for treating MCI

image_pdfDownload PDFimage_print

Biogen and Eisai Co., Ltd. announced results from a recent analysis of the ongoing long-term extension (LTE) Phase 1b study of aducanumab, an investigational treatment for mild cognitive impairment (MCI) due to Alzheimer’s disease (AD) and mild AD dementia. The updated analyses include data from the placebo-controlled period and LTE for patients treated with aducanumab up to 36 months in the titration cohort and up to 48 months in the fixed-dose cohorts. The results are generally consistent with previous interim analyses, and there were no changes to the risk-benefit profile of aducanumab.

The Phase 1b study is a randomized, double-blind, placebo-controlled, multiple-dose study evaluating the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and clinical effects of aducanumab in patients with prodromal AD or 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.

In the Phase 1b study 196 patients received aducanumab or placebo, of which 143 patients entered the LTE. 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. Additionally, there were discontinuations as expected in studies of 36 or more months. As a result, there are small patient numbers in the new analyses.

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. Clinical effects with titrated aducanumab in the second year of the LTE were generally consistent with findings in the 10 mg/kg fixed-dose cohorts.

Of the 185 patients dosed with aducanumab in the Phase 1b study, 46 patients experienced amyloid imaging abnormalities (ARIA)-E (edema). 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, the most commonly reported adverse events were headache, fall and ARIA.

Source:

http://investors.biogen.com/news-releases/news-release-details/biogen-and-eisai-report-data-long-term-extension-phase-1b-study

Posted in: Drug Trial News | Medical Condition News

Tags: Alzheimer’s Disease, Amyloid Plaque, Antibody, Biogen, Biotechnology, Compound, Dementia, Edema, Headache, Health Care, Imaging, Manufacturing, Monoclonal Antibody, Movement disorders, Multiple Sclerosis, Muscular Atrophy, Neurodegenerative Diseases, Neuroimmunology, Neurology, Neuroscience, Oncology, Ophthalmology, Pain, Pharmacodynamics, Pharmacokinetics, Placebo, Positron Emission Tomography, Research, Sclerosis, Spinal Muscular Atrophy, Titration

Tagged with:

About author

Related Articles