MN-166

ALS

Amyotrophic Lateral Sclerosis (ALS)

Amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig’s disease, is a progressive neurodegenerative disease that affects nerve cells in the brain and the spinal cord. The nerves lose the ability to trigger specific muscles, which causes the muscles to become weak. As a result, ALS affects voluntary movement and patients in the later stages of the disease may become completely paralyzed. Life expectancy of an ALS patient is usually 2-5 years. According to the ALS Association, there are approximately 20,000 ALS patients in the U.S. and approximately 5,000 people in the U.S. are diagnosed with ALS each year.

Neuroinflammation is thought to play a major role in ALS disease progression.

COMBAT-ALS TRIAL

  • The U.S. Food and Drug Administration and Health Canada has granted approval to conduct a Phase 2b/3 clinical trial of MN-166 (ibudilast) in ALS.
  • A multicenter, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy, safety and tolerability of MN-166 given to ALS participants for 12 months followed by a 6-month open-label extension phase.
    • The study is funded by MediciNova.
  • Currently recruiting patients at multiple study sites in U.S. and Canada.
  • The lead Principal Investigator of the study is Bjorn Oskarsson, M.D., Associate Professor, Department of Neurology, Mayo Clinic in Jacksonville, FL.
    • Oskarsson, Principal Investigator, commented, “This study aims to evaluate MN-166 on function and survival in patients living with ALS. We hope to show that when MN-166 is given together with riluzole, that it slows disease progression more effectively than riluzole alone.”
  • The study’s goal is to determine, through clinical trial testing, whether MN-166 (ibudilast) is an effective and safe treatment for patients living with ALS.
    • MN-166 (or placebo) is in a capsule form and is taken by mouth twice a day.
    • Enrolled participants will receive MN-166 or placebo for 12 months and receive MN-166 for an additional 6 months (called “open-label”).
  • At the time of screening, patients
    • Must have a diagnosis of sporadic or familial ALS with onset of 18 months or less from first clinical weakness
    • Must be on a stable dose of riluzole for at least 1 month before starting study drug treatment.
    • If currently using edaravone, subject should have completed at least one cycle of edaravone prior to Screening visit
      • To learn more about study eligibility, please visit https://clinicaltrials.gov/ct2/show/NCT04057898

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