A new analysis of Phase 2 clinical data on Innate Immunotherapeutics’ investigational drug MIS416 to treat secondary progressive multiple sclerosis 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, 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.

Innate Immunotherapeutics' MIS416 has failed to help secondary progressive multiple sclerosis (SPMS) patients in a Phase 2 clinical trial. 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."

Australia’s Innate Immunotherapeutics confirmed that its Phase 2b clinical trial evaluating the drug MIS416 in patients with secondary progressive multiple sclerosis (SPMS) will wrap up by April 30, as scheduled, and data is expected to be release in the fall. MIS416 is a biologically derived new immune modulator that can…

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…

As the most common non-traumatic cause of disability in young people in the industrialized world, multiple sclerosis affects more than 2.5 million people globally. Those who suffer with the disease are categorized into two types of multiple sclerosis patients: those with relapsing-remitting multiple sclerosis (RRMS) make up the majority of patients…

Under development at Innate Immunotherapeutics is a special drug candidate to treat secondary progressive multiple sclerosis (SPMS). Currently, no viable therapies exist for SPMS — only less-effective means to treat SPMS patients through drugs designed for relapse-remitting multiple sclerosis — making the prospect of Innate’s experimental SPMS therapy a…

New Zealand and Australia-based Innate Immunotherapeutics Limited, a biotechnology company with offices in Sydney and Auckland, has designed and manufactured a unique immunomodulator microparticle pharmaceutical technology. This technology can be used to induce the human immune system designed to fight certain cancers and infections, or modulate certain immune…

New Zealand and  Australian-based biotechnology company Innate Immunotherapeutics recently announced that it has begun to recruit patients with Secondary Progressive Multiple Sclerosis (SPMS) for its phase 2B trial of its experimental therapy MIS416. The study, which will be administered by the Western Australian…

In spite of an eight week delay, New Zealand-based Innate Immunotherapeutics is still planning to enroll patients for its phase 2b clinical trial that will study the experimental drug MIS416 for secondary progressive MS. The clinical research organization (CRO) involved in the management of the trial informed the company about the…

Australian biotechnology company Innate Immunotherapeutics’ trial for a drug designed to treat secondary progressive multiple sclerosis (SPMS) has produced positive results. Innate’s experimental MIS416 has revealed benefits to the majority of SPMS patients who were prescribed it as a “compassionate use drug,” given the total lack of…