Interesting results of phase 2 clinical trial for people with progressive MS

Results of phase 2 clinical trial of ibudilast suggest reduction of brain atrophy (shrinkage) in people with progressive MS

SUMMARY

  • Top-line results were announced of a phase 2 clinical trial testing an oral therapy ibudilast (MN-166, MediciNova, Inc.) in people with progressive forms of MS.
  • The results announced in a press release concluded that ibudilast was well tolerated and significantly slowed the rate of brain atrophy compared to placebo. Brain atrophy (shrinkage) has been linked to cognitive and physical disability in MS.
  • The trial was conducted at the Cleveland Clinic and 27 other sites across the U.S., and involved 255 people with primary or secondary progressive MS.
  • The study was principally funded by NeuroNEXT Network, a clinical trials initiative of the National Institutes of Health, with additional support by MediciNova, the company that supplied ibudilast. The National MS Society also provided funding support.
  • Further details are schedule to be presented Saturday, October 28th at the MSParis2017 – 7th Joint ECTRIMS-ACTRIMS Meeting.
  • These phase 2 results may lead the way to the testing of ibudilast in larger phase 3 trial(s), which would be needed before the company could apply for marketing approval from the FDA, the European Medicines Agency or other regulatory agencies.

“Positive results from this trial, which focuses on neuroprotection, are an important milestone in the search for treatments for people with progressive MS, and the outcome measures built into the design will inform and help refine trials in the future,” noted Dr. Alan Thompson, Chair of the International Progressive MS Alliance’s Scientific Steering Committee and Dean of University College London Faculty of Brain Sciences.

DETAILS
Background: Ibudilast (MN-166, MediciNova, Inc.) inhibits an enzyme called phosphodiesterase. While considered a “New Molecular Entity” in the United States and Europe, ibudilast is marketed in Japan and Korea to treat cerebrovascular disorders and asthma. It is being also being investigated in the U.S. for its potential to treat ALS and drug addiction.

The study was principally funded by NeuroNEXT Network, a clinical trials initiative of the National Institutes of Health, with additional support by MediciNova, the company that will supply ibudilast. The National MS Society also provided funding support because of its focus on progressive MS and because the trial’s design may answer important questions about the best ways to measure the benefits of therapies aimed at protecting the nervous system from MS.

The study: The trial, known as “SPRINT-MS,” was led by Principal Investigator Robert Fox, M.D., M.S., FAAN, Staff Neurologist at the Mellen Center for Multiple Sclerosis at Cleveland Clinic. It was conducted at the Cleveland Clinic and 27 other sites across the U.S. The trial involved 255 people with primary or secondary progressive MS. The primary outcome measure was change in brain atrophy (as measured by an MRI analysis technique called brain parenchymal fraction) after 96 weeks. Brain atrophy (shrinkage) has been linked to cognitive and physical disability in MS. Other imaging, safety, clinical and quality of life outcomes were also measured.

The results announced in a press release from MediciNova concluded that ibudilast was well tolerated and significantly slowed the rate of brain atrophy compared to placebo. Further details are schedule to be presented on Saturday, October 28th at the MSParis2017 – 7th Joint ECTRIMS-ACTRIMS Meeting.

What’s Next? These phase 2 results may lead the way to the testing of ibudilast in larger phase 3 trial(s), which would be needed before the company could apply for marketing approval from the FDA, the European Medicines Agency or other regulatory agencies.

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