The company said it will continue testing the therapy, made up of natural compounds, to see if it can benefit any MS subgroups.
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.
“It is disappointing that these results don’t show benefit for people with secondary progressive MS, for whom there are few treatment options,” Dr. Bruce Bebo, executive vice president of research at the National MS Society, said in a news release.
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. Deterioration of the coating is a hallmark of the disease.
The one-year trial (NCT02228213) tested the safety and effectiveness of MIS416 on 93 patients with SPMS in Australia and New Zealand. The patients randomly received MIS416 or a placebo once a week.
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.
In addition, there were no differences between in disease outcomes that patients reported. The self-reported barometers included the Multiple Sclerosis Impact Scale, the Neurological Fatigue Index, and the Brief Pain Inventory.
“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.”
In addition to MIS416 failing to be effective, the group who received it had more treatment-related adverse events than the placebo group. The events were mainly related to the first dose, Innate said. The main problems were fever, chills, and muscle weakness.
The company has been providing MIS416 to Australian MS patients under a compassionate use program.
It said it will continue evaluating the safety and tolerability of the drug to see if it helps any subgroups of patients. Those findings will determine the future of the compassionate use program, it said.
“These results are a shock, and definitely not what we were expecting based on our previous clinical experience with MIS416 and the reporting of treatment benefits we have received from many compassionate use patients over an extensive eight-year period,” said Simon Wilkinson, Innate Immunotherapeutics’ chief executive officer. “These data will be as distressing to them as they will be for all the stakeholders who were relying on the outcome of this study.”
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