Innate Immunotherapeutics has recently announced that the Western Australian Neuroscience Research Institute (WANRI) has received approval to commence patient recruitment for the Company’s phase trial of MIS416 in patients with Secondary Progressive Multiple Sclerosis (SPMS).
The ethics approval was granted by Bellberry Human Research Ethics Committees (HREC)–an independent ethics review board compliant with strict National Health and Medical Research Council (NHMRC) guidelines for clinical trials.
The approval enables WANRI to commence patient recruitment immediately with the first patients expected to be dosed with in the next 2-3 weeks following extensive baseline measurements of their present MS related symptoms.
WANRI has been selected by Innate as the study's lead site due to its strong focus on investigating the causes and improving the therapy and management of patients suffering from multiple sclerosis.
The Institute has a strong focus on providing the best clinical management for multiple sclerosis available. “We are really pleased to be leading this trial. SPMS affects 30 per cent 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,”said Dr Allan Kermode, clinical Professor of Neuroimmunology at WANRI.
The phase 2B trial will recruit up to 90 SPMS patients a cross multiple sites in Australia . The trial is a double blinded randomised study where 60 patients will receive MIS416 and 30 will receive a placebo. Patient will be treated once weekly for 12 months.
The primary goal of the trial is to determine the efficacy and safety of MIS416 compared to patients treated with the placebo. Previous non-placebo controlled MIS416 studies found that 80 per cent of patients with SPMS had shown a 30 per cent or greater improvement in at least one measure of their MS-related symptoms.
Notably,patient stakeholder groups such as Multiple Sclerosis Research Australia (MSRA) and the United States National Multiple Sclerosis Society (US MS Society) have both expressed strong support of Innate’s pursuit of an effective treatment for SPMS.Dr Matthew Miles, chief executive officer, of MSRA said: “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.”
The Company expects key trial sites in the Eastern States to obtain ethics approval over the next month with other centres to follow.