Breaking News
January 20, 2018 - Morning Break: Missing Maria Deaths; N.J. Doc Charged in Wife’s Murder; Viva Vaseline!
January 20, 2018 - No interventions proven to prevent late-life dementia
January 20, 2018 - Judge orders new Olympus trial over superbug death
January 20, 2018 - Don’t Rely on Just One Blood Pressure Test for Kids: Study
January 20, 2018 - Going Off the Deep End About Water
January 20, 2018 - Parental attention can reduce risk of drug abuse in adolescence
January 20, 2018 - Mast Uri System offers efficient and cost-friendly diagnostic solution
January 20, 2018 - International SOS, Chatham House sign partnership agreement to further advance Global Health Security Agenda
January 20, 2018 - Study offers way to predict onset of lung disease in children with cystic fibrosis
January 20, 2018 - C-Suite Must Lead in Ending Sexual Harassment
January 20, 2018 - Researchers find a way to ‘starve’ cancer
January 20, 2018 - Applied math can help predict genesis and evolution of different cancers
January 20, 2018 - UCLA researchers describe herpes virus structure associated with Kaposi’s sarcoma
January 20, 2018 - New study enrolls first patient to evaluate potential of WaveCrest LAAO System
January 20, 2018 - New review explores effects of exposing developing brains to general anesthesia
January 20, 2018 - GW Pharmaceuticals Announces Acceptance of NDA Filing for Epidiolex (cannabidiol) in the treatment of Lennox-Gastaut syndrome and Dravet syndrome
January 20, 2018 - Weight-Loss Surgery Approaches Offer Similar Results
January 20, 2018 - Free online access to millions of documents on chemical toxicity
January 20, 2018 - CE marked MAST Toxoreagent kit for detection of Toxoplasma antibodies
January 20, 2018 - DNA study sheds light on longstanding puzzle of cell division
January 20, 2018 - Montefiore provides specialized medical care to parents of adopted children
January 20, 2018 - Enzyme discovery provides new horizon of therapeutic opportunities across disease spectrum
January 20, 2018 - New smartphone app successfully enables remote monitoring of surgical wounds
January 20, 2018 - Liquid Biopsy Shows Promise for Colon Cancer
January 20, 2018 - Surgery death rates in Africa are twice global average: study
January 20, 2018 - New isothermal amplification kit using LAMP technology
January 20, 2018 - Pretreatment improves outcomes in high-risk stage 3 melanoma, study shows
January 20, 2018 - Health Highlights: Jan. 17, 2018
January 20, 2018 - House Opioid Task Force has Big Plans for 2018
January 20, 2018 - Perfectionism among young people significantly increased since 1980s, study finds
January 20, 2018 - Evidensia Sweden orders Sectra cloud-based PACS for reviewing all medical images
January 20, 2018 - Researchers test new anti-malaria medication
January 20, 2018 - Small Joint Surgeries Drop among RA Patients
January 20, 2018 - Young people with shared residency have fewer mental problems
January 20, 2018 - Childhood physical activity may have far-reaching implications
January 20, 2018 - Overweight female kidney donors of childbearing age may have greater preeclampsia risk
January 20, 2018 - MSU scientists seek to identify brain mechanisms related to psychosis
January 20, 2018 - CBT is cost-effective treatment in primary care setting, Kaiser Permanente study finds
January 20, 2018 - Scientists find how potential new eczema treatment could also alleviate asthma
January 20, 2018 - Older hospitalized patients less likely to be tested for influenza
January 20, 2018 - Syndax Pharmaceuticals Announces Clinical Collaboration to Evaluate Entinostat in Combination with anti-PD-L1 Cancer Immunotherapy in Breast Cancer
January 20, 2018 - Endoscopes Over Microscopes in Retinal Surgery: Ophthalmology Times
January 20, 2018 - Technology not taking over children’s lives despite screen-time increase
January 20, 2018 - Study finds extensive contamination around lead battery recycling plants in 7 African countries
January 20, 2018 - Flu may pass to others through exhaled breath, study shows
January 20, 2018 - Neuronal loss very limited in Alzheimer’s disease, new study shows
January 20, 2018 - Novel robot can aid treatment of rare birth defect
January 19, 2018 - TherapeuticsMD Announces Submission of New Drug Application for TX-001HR
January 19, 2018 - Fighting Infant Mortality | Medpage Today
January 19, 2018 - Researchers offer new evidence on four-year-old children’s knowledge about ecology
January 19, 2018 - Analysis finds overlooked crucial factor in determining prognosis for DIPGs
January 19, 2018 - Review explores consequences of genetic testing and cancer risk-reducing surgery
January 19, 2018 - Morning Break: HHS Div. of Religious Freedom; Trump’s Heart Health; Minister of Loneliness
January 19, 2018 - Parkinson’s disease ‘jerking’ side effect detected by algorithm
January 19, 2018 - New analysis finds dramatic increases in maternal mortality rates
January 19, 2018 - Study provides more evidence for link between increased cancer risk and advanced gum disease
January 19, 2018 - Study reveals key mechanism of how cancer metastasis happens
January 19, 2018 - Weight-Loss Surgery’s Benefits Wane Over Time for Diabetics
January 19, 2018 - Cath Lab Recap: Sapien 3 Delivery System Recall; Transatlantic PCI Smackdown
January 19, 2018 - Parkinson’s treatment could be more effective, student finds
January 19, 2018 - New vaccine approach offers effective protection against tuberculosis
January 19, 2018 - Home care agencies often wrongly deny Medicare help to the chronically ill
January 19, 2018 - One hundred percent fruit juice does not alter blood sugar levels
January 19, 2018 - Prebiotics could enhance learning and memory skills in infants
January 19, 2018 - CMS May Cover MRI With Cardiac Devices Across the Board
January 19, 2018 - As income rises, women get slimmer—but not men
January 19, 2018 - Researchers develop adhesive materials to prevent bracket stains on teeth
January 19, 2018 - Flu can be spread without coughs and sneezes
January 19, 2018 - AMSBIO’s new recombinant protein shows great promise for organoid culture
January 19, 2018 - AbbVie’s Upadacitinib Granted Breakthrough Therapy Designation from the U.S. Food and Drug Administration for Atopic Dermatitis
January 19, 2018 - ASH: Pomalidomide Dose Escalation Improves Response
January 19, 2018 - AMSBIO offers isogenic panels of neuronal iPSC derivatives
January 19, 2018 - Is your child’s school an obesity risk?
January 19, 2018 - Scientists describe groundbreaking training effect on the innate immune system
January 19, 2018 - MAST announces new AmpC, ESBL & Carbapenemase Detection Set
January 19, 2018 - Signaling molecules likely involved in concussions, rodent studies show
January 19, 2018 - Mast introduces Carba plus for CPE and OXA-48 confirmation
January 19, 2018 - Paleolithic diet helps overweight women maintain weight loss
January 19, 2018 - Agios Submits New Drug Application to the FDA for Ivosidenib for the Treatment of Patients with Relapsed/Refractory AML and an IDH1 Mutation
January 19, 2018 - This Flu Season, Don’t Forget About Tamiflu
New Data from Long-Term Extension of Phase 1b Study of Investigational Alzheimer’s Disease Treatment Aducanumab Presented at 10th Clinical Trials on Alzheimer’s Disease

New Data from Long-Term Extension of Phase 1b Study of Investigational Alzheimer’s Disease Treatment Aducanumab Presented at 10th Clinical Trials on Alzheimer’s Disease

image_pdfDownload PDFimage_print

TOKYO, Nov 6, 2017 – (ACN Newswire) – Eisai Co., Ltd. announced today that Biogen Inc. (Nasdaq: BIIB) presented new data from the long-term extension (LTE) of its ongoing Phase 1b study of aducanumab, an investigational treatment for Alzheimer’s disease at the 10th Clinical Trials on Alzheimer’s Disease (CTAD) meeting, Boston, Massachusetts, United States, from November 1 to 4.

As of October 23, 2017, Eisai and Biogen entered into a global collaboration agreement to jointly develop and commercialize aducanumab.

The data include results from patients in the Phase 1b study of aducanumab who were treated with a gradually increased dose of aducanumab for up to 24 months and those who were treated with a fixed dose of 3, 6 or 10 mg/kg aducanumab for up to 36 months.

  • Two-year data from Phase 1b study suggest a continued benefit on amyloid plaque reduction and the rate of clinical decline in the titration regimen group, which received a gradually increased aducanumab dose
  • The results at two years in the titration regimen group were consistent with the dose- and time-dependent results observed in the treatment groups that received a fixed-dose of 3, 6 or 10 mg/kg aducanumab during the same time period
  • Results from treatment groups that received a fixed-dose of 3, 6 or 10 mg/kg aducanumab for up to three years were consistent with previously reported analyses from the Phase 1b study and support the design of the ongoing Phase 3 studies of aducanumab for early Alzheimer’s disease

The results from the Phase 1b study of aducanumab including the new data from the LTE have further deepened Eisai’s conviction in the amyloid hypothesis. Eisai plans to advance co-development with Biogen and hopes to create the world’s potentially first new treatment for Alzheimer’s disease based on the amyloid hypothesis as early as possible.

About Aducanumab (BIIB037)

Aducanumab (BIIB037) is an investigational drug being developed for the treatment of AD. Aducanumab is a human recombinant monoclonal antibody (mAb) derived from a de-identified library of B cells collected from healthy elderly subjects with no signs of cognitive impairment or cognitively impaired elderly subjects with unusually slow cognitive decline using Neurimmune’s technology platform called Reverse Translational Medicine (RTM). Biogen licensed aducanumab from Neurimmune under a collaborative development and license agreement. Aducanumab is being jointly developed by Biogen and Eisai, with Eisai having exercised its option to co-develop and co-promote aducanumab on October 23, 2017.

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 European Medicines Agency’s PRIME program. In September 2016 the U.S. Food and Drug Administration accepted aducanumab into its Fast Track program and in April 2017 aducanumab was accepted into the Japanese Ministry of Health, Labour and Welfare’s (MHLW) SAKIGAKE(1) Designation System.

(1) SAKIGAKE aims at shortening premarket review period for innovative new medical products that satisfy certain criteria, such as severity of intended indication, by designating such products during the early stages of development, and providing prioritized consultation services and premarket pharmaceutical affairs review. The target review period for the designated products may be reduced to as short as 6 months, half the standard review period of 12 months for typical new pharmaceutical products.

About the Phase 1b study

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 or mild Alzheimer’s disease. 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 LTE, the most commonly reported adverse events were headache, fall and amyloid-related imaging abnormalities (ARIA). Of the 185 patients dosed with aducanumab in the Phase 1b study, 46 patients experienced ARIA-E (edema). There were no new cases of ARIA-E in patients who continued on the same dose of aducanumab.

About Eisai

Eisai Co., Ltd. (TSE:4523; ADR:ESALY) is a research-based human health care (hhc) company that discovers, develops and markets products throughout the world. Eisai focuses its efforts in three therapeutic areas: integrative neuroscience, including neurology and psychiatric medicines; integrative oncology, which encompasses oncotherapy and supportive-care treatments; and vascular/immunological reaction. Through a global network of research facilities, manufacturing sites and marketing subsidiaries, Eisai actively participates in all aspects of the worldwide healthcare system. For more information about Eisai Co., Ltd., please visit www.eisai.com.

Source: Eisai Co., Ltd.

Posted: November 2017

Tagged with:

About author

Related Articles