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Results Announced from Phase 2 Trial of MIS416 in Secondary Progressive MS Suggest No Benefit

June 27, 2017

Top-line results of a one-year, phase 2 clinical trial of MIS416 in secondary progressive MS have been announced by the study’s sponsor, Innate Immunotherapeutics Limited.
  • None of the clinical or MRI measures suggested benefit of MIS416 over placebo.
  • The company announced plans to continue analyzing the results for safety and benefits, and to determine whether its compassionate use program, which makes MIS416 available to some people with secondary progressive MS in Australia, will continue.
Background: MIS416 is a naturally occurring agent derived from bacteria that can alter immune responses. Innate Immunotherapeutics Limited, has been supporting research into MIS416 for the treatment of secondary progressive MS. In 2010, the National MS Society, through it Fast Forward commercial research funding mechanism, helped to support its early testing. The company has been making MIS416 available through a compassionate use program in Australia.
The Study: The recently completed trial was a one-year, phase 2 trial involving 93 people with secondary progressive MS in Australia and New Zealand. About two-thirds of them were randomly assigned to receive weekly intravenous (into vein) injections of MIS416, and the rest received inactive placebo. The team tested a variety of outcomes including walking speed, vision, cognition, progression of disability, MRI brain scans, and participants’ impressions of the benefits of the therapy. None of the measures showed significant differences between those on active therapy and those on placebo.
In terms of safety and tolerability, the announcement notes that there was a higher incidence of adverse events in those taking MIS416 possibly associated with the fever, chills, muscle weakness that some experienced after the first dose.
Conclusions: “It is disappointing that these results don’t show benefit for people with secondary progressive MS, for whom there are few treatment options,” said Bruce Bebo, PhD, Executive Vice President, Research, at the National MS Society.
The study’s sponsor, Innate Immunotherapeutics Limited, announced plans to continue analyzing data to see if there were any subgroups of participants who responded to therapy, to further understand the drug’s tolerability, and to determine whether its compassionate use program will continue.

About Multiple Sclerosis

Multiple sclerosis is an unpredictable, often disabling disease of the central nervous system. Symptoms range from numbness and tingling to blindness and paralysis, and there is currently no cure for MS. The progress, severity and specific symptoms of MS in any one person cannot yet be predicted, but advances in research and treatment are leading to better understanding and moving us closer to a world free of MS. An estimated 1 million people live with MS in the United States. Most people with MS are diagnosed between the ages of 20 and 50, and it affects women three times more than men.


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