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 Neuroscience Research Institute (WANRI), was recently approved by the Bellberry Human Research Ethics Committees (HREC), allowing the clinical trials to commence.
The approval granted by the independent ethics review board indicates that Innate’s study complies with strict National Health and Medical Research Council (NHMRC) guidelines for clinical trials, which will allow WANRI to initiate the recruitment process immediately. As a result, the company is expecting to start dosing the first patients during the next 2-3 weeks, after performing extensive baseline measurements of their present MS related symptoms.
“We are really pleased to be leading this trial,” said Dr. Allan Kermode, a clinical Professor of Neuroimmunology at WANRI. “SPMS affects 30% of the MS population at any moment in time, and there are no approved long term effective treatment options for these patients. We all hope that MIS416 might be the drug to address this urgent need.”
For the double blinded randomized trial, the company will recruit up to 90 SPMS patients in Australia, 60 of which will be given MIS416 and the other 30 with placebo. Both of the groups will be treated once weekly for 12 months. The research team aims to determine the efficacy and safety of MIS416 compared to patients treated with the placebo.
The biologically derived novel immune modulator MIS416 targets not only the regulatory functions, but also the defensive functions of the innate immune system, and it is the first MS drug to attack the myeloid cells, which is a sub-set of innate immune cells that have only recently been recognized as important in the treatment of SPMS. Previous trials have already demonstrated that the drug improved the symptoms of 80% of patients with SPMS by 30% or more in at least one measure of their MS-related symptoms.
Multiple Sclerosis Research Australia (MSRA) and the United States National Multiple Sclerosis Society (US MS Society) have already expressed strong support of Innate’s pursuit of an effective treatment for SPMS. “Australia has a strong cohort of world-leading MS neurologists who are highly experienced clinical trial investigators and strongly committed to supporting the development of new treatments for their patients,” explained the CEO of MSRA, Dr. Matthew Miles.
The next step is to extend the key trial sites to the Eastern States, which the company expects to start by next month.