A new analysis of Phase 2 clinical data on Innate Immunotherapeutics’ investigational drug MIS416 to treat secondary progressive multiple sclerosis (SPMS) has confirmed that the drug failed to improve neuromuscular function or patient reported outcomes.
The initial evaluation of data obtained from the one-year trial (NCT02228213), announced in June, showed disappointing results. These results, gleaned from 70 patients who were randomly designated to receive either weekly injections of MIS416 or a placebo control, failed to demonstrate significant differences or clinically meaningful improvements in patients treated with MIS416 compared to those in the control group.
After this initial setback, the Australian company sponsored an additional analysis of the trial results to identify any potential subgroup of clinical responders that could benefit from MIS416 and who might have been masked in the first population-based analysis. However, this post-hoc analysis also failed to show any positive effects of MIS416.
Although the detailed report of this second analysis has not yet been released, the Sydney-based company conceded that the final outcome will not change.
“All previous reports of MIS416 making a meaningful difference in the lives of many patients must either be dismissed as a very robust placebo effect or the trial failure is attributable to some other reason. It is my view that there may be other reasons,” Innate CEO Simon Wilkinson said in a press release.
“Patients with SPMS have a complex mix of symptoms and their disease can’t be monitored by a simple blood test or MRI scan,” he added. “We used the best assessment tools available as recommended by expert practitioners in MS, but we suspect they weren’t sensitive enough to pick up the small but potentially significant changes that can lead to a substantial impact on patients’ activities of daily living and quality of life.”
The lack of efficacy of MIS416 shown by the trial results is inconsistent with previous clinical experience, and the benefits reported by those receiving MIS416 for the past eight years.
“Whatever the possible explanations, we have not delivered a result that would support our continued trialing of MIS416 in patients with SPMS,” said Michael Quinn, Innate’s chairman. “We now need to look to the future of Innate. In doing so we are mindful of the interests of our shareholders and other committed stakeholders including patients still receiving MIS416 on compassionate-use grounds in Australia and New Zealand.”
The company plans to review any potential applications for MIS416 in the next two to three months.