• SKIP TO CONTENT
  • SKIP NAVIGATION
  • Patient Resources
    • COVID-19 Patient Resource Center
    • Clinical Trials
    • Search Clinical Trials
    • Patient Notification System
    • What is Clinical Research?
    • Volunteering for a Clinical Trial
    • Understanding Informed Consent
    • Useful Resources
    • FDA Approved Drugs
  • Professional Resources
    • Research Center Profiles
    • Clinical Trial Listings
    • Market Research
    • FDA Approved Drugs
    • Training Guides
    • Books
    • eLearning
    • Events
    • Newsletters
    • White Papers
    • SOPs
    • eCFR and Guidances
  • White Papers
  • Trial Listings
  • Advertise
  • COVID-19
  • iConnect
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » Biogen Idec to discontinue development of ALS drug

Biogen Idec to discontinue development of ALS drug

January 4, 2013
CenterWatch Staff

Weston, Mass.-based Biogen Idec has decided to discontinue development of dexpramipexole in amyotrophic lateral sclerosis (ALS), after top-line results of EMPOWER, its phase III trial, did not meet its primary endpoint, a joint rank analysis of function and survival, and no efficacy was seen in the individual components of function or survival.

The trial also failed to show efficacy in its key secondary endpoints. Additional analyses of multiple subpopulations failed to demonstrate any efficacy among these groups.

"We share the disappointment of members of the ALS community, who had hoped that dexpramipexole would offer a meaningful new treatment option,” said Douglas E. Williams, Ph.D., executive vice president of R&D, Biogen Idec. “Nevertheless, the EMPOWER trial represents a significant contribution to ALS research, and Biogen Idec is committed to advancing ALS science. We continue to work with researchers around the world to understand the causes of ALS and find potential treatments for people with ALS.”

The company intends to present detailed results at a future medical conference.

EMPOWER was a randomized, double-blind, placebo-controlled phase III trial which enrolled 943 people with ALS at 81 sites in 11 countries. Patients were randomized on a one-to-one basis to receive either dexpramipexole or placebo. The primary endpoint was a joint rank analysis of function and survival, known as the Combined Assessment of Function and Survival (CAFS). In addition to CAFS, the trial individually evaluated functional decline, survival and respiratory decline, among other measures.

“As a physician who has treated people with ALS, I hoped with all my heart for a different outcome,” said Douglas Kerr, M.D., Ph.D., director of neurodegeneration clinical research at Biogen Idec. “While these results were not what we expected, we hope these data will provide a foundation for future ALS research.”

Biogen Idec has several programs underway in ALS. The company recently entered into a research collaboration with Duke University and HudsonAlpha Institute to sequence the genomes of up to 1,000 people with ALS over the next five years in an effort to gain a deeper understanding about the fundamental genetic causes of the disease. Duke and HudsonAlpha will work with several world-class researchers who have deep expertise and experience with ALS and the genes associated with the disease.

Biogen Idec also recently created a research consortium in collaboration with several leading academic research centers to identify new approaches to treating ALS. Each of the centers involved in this consortium brings different scientific and technical expertise and a shared goal of improving the understanding of ALS from a basic science perspective.

In addition, Biogen Idec has committed significant funds to the University of Massachusetts Medical School ALS Champion Fund. The funding will drive awareness of ALS and support basic and clinical science research into potential treatments for ALS and other neurodegenerative diseases.

Upcoming Events

  • 16Feb

    Fundamentals of FDA Inspection Management: Reduce Anxiety, Increase Inspection Success

  • 21May

    WCG MAGI Clinical Research Conference – 2023 East

Featured Products

  • Spreadsheet Validation: Tools and Techniques to Make Data in Excel Compliant

    Spreadsheet Validation: Tools and Techniques to Make Data in Excel Compliant

  • Surviving an FDA GCP Inspection

    Surviving an FDA GCP Inspection: Resources for Investigators, Sponsors, CROs and IRBs

Featured Stories

  • SurveywBlueBackground-360x240.png

    Sites Name Tech Acceptance as Essential Factor in Selection of Sponsors, Survey Finds

  • TrendsInsights2023-360x240.png

    WCG Clinical Research Trends and Insights for 2023, Part Two

  • TimeMoneyEffort-360x240.png

    Time is Money and So Is Effort, Budgeting Experts Say

  • TrendsInsights2023A-360x240.png

    WCG Clinical Research Trends and Insights for 2023, Part Three

Standard Operating Procedures for Risk-Based Monitoring of Clinical Trials

The information you need to adapt your monitoring plan to changing times.

Learn More Here
  • About Us
  • Contact Us
  • Privacy Policy
  • Do Not Sell or Share My Data

Footer Logo

300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

Phone 617.948.5100 – Toll free 866.219.3440

Copyright © 2023. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing