Innate Immunotherapeutics Fully Enrolls Phase 2 Study of Drug Candidate to Treat SPMS

Innate Immunotherapeutics, Ltd., announced that it has completed patient enrollment in its ongoing Phase 2B, placebo-controlled clinical trial assessing the efficacy and safety of the drug MIS416 as a once-weekly treatment for secondary progressive multiple sclerosis (SPMS).

MIS416 is a biologically derived immune modulator that targets myeloid cells, a subset of innate immune cells that can play an important role in SPMS by downregulating brain inflammation, helping to clear myelin debris, and by upregulating tissue repair processes.

“SPMS is a devastating condition that currently has no effective treatment,” Professor Peter Panegyres, a principal trial investigator in Perth, Australia, said in a press release. “We’re excited to be part of a trial that could see the development of a therapy that helps people living with SPMS manage their symptoms.”

An advanced disease stage that often develops in relapsing-remitting MS patients, SPMS is marked by a sustained build-up of disability independent of any relapses. Professor Panegyres said that 75 percent of relapsing MS patients develop SPMS, with severe loss of mobility and independence.

The 12-month clinical study (NCT02228213) has already treated 13 patients, and nine of these participants have requested access to MIS416 post-study, the company said in the release, adding that it will make the drug available to those who complete the trial. The National MS Society in the U.S. provided Innate with early funding through its commercial research arm, Fast Forward LLC.

The Society is “very pleased to learn that Innate Immunotherapeutics has now fully recruited patients into the trial of MIS416 in people with SPMS. We look forward to learning the outcome of the trial, as there are currently limited options available for treating this debilitating stage of MS,” said Dr. Bruce Bebo, the Society’s executive vice president for Research.

“Drugs used in early stage MS aren’t effective in treating SPMS so finding a treatment for patients that slows the deterioration of their symptoms is very important,” added Dr. Pamela McCombe, a neurologist at Wesley Hospital in Brisbane, Australia, and another principal investigator.

Innate, an Australian biotechnology company, expects to complete the study by April 2017 and release initial data soon afterward.

“I’m confident that a successful trial result in the first half of next year will quickly translate into a major partnering transaction,” Simon Wilkinson, Innate’s CEO, added.