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Pipeline Drug MIS416 Fails to Benefit SPMS Patients

July 5, 2017

Innate Immunotherapeutics’ MIS416 has failed to help secondary progressive multiple sclerosis (SPMS) patients in a Phase 2 clinical trial. Trial participants who received MIS416 had no meaningful improvements in neuromuscular function or the outcome of their disease compared with those who took received a placebo. Scientists hoped the injected therapy would modulate the activity of immune cells that affect the protective myelin coating around nerve cells, decreasing the inflammation and brain tissue damage associated with MS.  

The one-year trial tested the safety and effectiveness of MIS416 on 93 patients with SPMS. There were no differences in the groups’ scores on a disability index, the expanded disability status scale, or in brain volume changes detected by magnetic resonance imaging. There were also no differences between in disease outcomes that patients reported. In addition to MIS416 failing to be effective, the group who received it had more treatment-related adverse events than the placebo group.

“I am extremely disappointed by this outcome,” Professor Pam McCombe, a principal trial investigator, said in a company press release. “Looking for measurable changes in patients with progressive MS using the assessment tools currently at our disposal is frustrating and complicated. We were hopeful that MIS416 would be an option to treat this group of patients who currently do not have effective treatment options.”

However, the company said it will continue testing the therapy, which is made up of natural compounds. They will continue evaluating the safety and tolerability of the drug to see if it helps any subgroups of patients.