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Biogen Presents New Data from Long-Term Extension of Phase 1b Study of Investigational Alzheimer's Disease Treatment Aducanumab.

M2 PHARMA-November 3, 2017-Biogen Presents New Data from Long-Term Extension of Phase 1b Study of Investigational Alzheimer's Disease Treatment Aducanumab

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- US-based neuroscience specialist Biogen (NASDAQ: BIIB) will present new data from the long-term extension of its ongoing Phase 1b study of aducanumab, the company's investigational treatment for Alzheimer's disease, at the Clinical Trials on Alzheimer's Disease meeting, Boston, November 1 4, the company said.

The data include results from patients in the Phase 1b study 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.

According to the company, the results are 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.

"We now have up to three years of results from the Phase 1b study of aducanumab and during this time period we continued to observe reduction of the biomarker, amyloid plaque," said Alfred Sandrock, M.D., Ph.D., executive vice president and chief medical officer at Biogen. "The results also suggest there is a benefit on clinical decline for patients in the Phase 1b study, especially at the highest doses of aducanumab. Our Phase 3 studies of aducanumab are ongoing to determine whether it may be a potential treatment for early Alzheimer's disease."

The Phase 1b study is a randomised, double-blind, placebo-controlled, multiple-dose study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics 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.

New analyses presented at CTAD include 143 patients in several groups.

Patients initially randomised to titration dosing that gradually increased aducanumab from 1 to 3 to 6 then 10 mg/kg in the 54-week placebo-controlled period and treated up to 24 months.

Patients randomised to aducanumab 3, 6 or 10 mg/kg in the 54-week placebo-controlled period and treated up to 36 months. Patients who were randomised to placebo or aducanumab 1 mg/kg in the 54-week placebo-controlled period who were switched to aducanumab 3 mg/kg or to a 3 to 6 mg/kg titration regimen in the LTE and treated up to 24 months.

Finally, patients who were randomised to placebo in the 54-week placebo-controlled period who were switched to titration dosing that gradually increased their dose from 1 to 3 to 6 then 10 mg/kg in the LTE and treated up to 12 months.

In the Phase 1b LTE, the most commonly reported adverse events were headache, fall and amyloid-related imaging abnormalities. 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.

The incidence of ARIA-E in patients switching from placebo to aducanumab in the LTE was consistent with the incidence reported in the placebo-controlled portion of the Phase 1b study.

Aducanumab is currently being evaluated in two global Phase 3 studies, ENGAGE and EMERGE, which are designed to evaluate its safety and efficacy in slowing cognitive impairment and the progression of disability in people with early Alzheimer's disease.

Aducanumab (BIIB037) is an investigational compound being developed for the treatment of Alzheimer's disease.

Aducanumab is a human recombinant monoclonal antibody 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.

Biogen licensed aducanumab from Neurimmune under a collaborative development and license agreement.

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 US 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 Sakigake Designation System.

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

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