We use cookies to provide you with a better experience. By clicking the Accept button, you are agreeing to our use of cookies in accordance with our Privacy Policy.
  • Patient Resources
    • 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
    • Glossary
  • Professional Resources
    • Research Center Profiles
    • Industry Provider Profiles
    • Market Research
    • FDA Approved Drugs
    • Training Guides
    • Books
    • Events
    • Newsletters
    • JobWatch
    • White Papers
    • Patient Education
    • SOPs
  • About Us
  • Contact Us
  • Advertise
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » Treeway sees positive data results for ALS treatment

Treeway sees positive data results for ALS treatment

December 10, 2015
CenterWatch Staff

Treeway, a biotech company developing therapies against amyotrophic lateral sclerosis (ALS), today announced the completion of two successful phase I trials with its lead compound TW001, a more patient-friendly oral formulation of the Japanese stroke and ALS therapy edaravone.

Founded by two Dutch ALS patients, Rotterdam, Netherlands-based Treeway seeks to speed up ALS research in collaboration with academic and research centers around the globe.

TW001 was tested in both single- and multiple-dose phase l studies in healthy volunteers and in ALS patients. In the two studies, TW001 was shown to be safe and well-tolerated, and adequate exposure levels with the oral formulation were detected. Based on those trial data, the company is now aiming to start a pivotal phase II/III study in 2016. Earlier, Treeway obtained Orphan Drug designation for edaravone of ALS from both the FDA and EMA.

Treeway CEO Inez de Greef said of the trial outcome, β€œThe positive results of our phase I program are an important milestone for the development of TW001 for ALS. This outcome not only represents a significant achievement for our company, but first offers important new patient-friendly aspects to the treatment of ALS. We look forward to sustaining this momentum in the coming months, as preparations for the pivotal phase II/III clinical study are now ongoing.”

Edaravone is a well-established free radical scavenger that targets oxidative stress, a process that plays an important role in ALS. Intravenously administered edaravone has been shown to slow down disease progression in ALS patients in previous Japanese clinical trials.

Currently, edaravone is marketed in Japan by Mitsubishi Tanabe Pharma as an intravenous formulation (Radicut) for the indication stroke and ALS. The intravenous formulation of edaravone is administered to ALS patients via one-hour infusions in a hospital setting. Drug-holiday cycles are part of the treatment regimen; patients are treated 10 out of 28 days.

Global News Clinical Intelligence

Upcoming Events

  • 09Dec

    The Age of eSource: Modernizing Clinical Trials

  • 16Dec

    Master the Regulatory Pathway for Cell & Gene Therapy Submissions: Strategies for Successful BLAs

Featured Products

  • Regenerative-medicine-steps-to-accelerate-development-pdf

    Regenerative Medicine: Steps to Accelerate Development β€” PDF

  • Clinical-trial-agreements-a-guide-to-key-words-and-phrases-pdf

    Clinical Trial Agreements: A Guide to Key Words and Phrases β€” PDF

Featured Stories

  • Patient-phsyician-consultation

    Giving Patients Back Their Voice in Clinical Trials

  • Ich_logo

    ICH Overhauls 22-Year-Old Clinical Studies Guideline

  • Survey_chart2019

    Sponsors, CROs Doing Better, Sites Say, But More Work Is Needed

New!

2019 Site Survey Reports

Learn More Here
  • About Us
  • Contact Us
  • Privacy Policy

Footer Logo

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

Phone 617.948.5100 – Toll free 866.219.3440

Copyright © 2019. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing