18 December 2012 | Regulatory | By BioSpectrum Bureau
Innate Immunotherapeutics secondary progressive multiple sclerosis (SPMS) drug gets US patent
Singapore: A new drug for the treatment of secondary progressive multiple sclerosis (SPMS) called MIS416, developed by New Zealand biopharmaceutical company Innate Immunotherapeutics, has been granted a patent in the US.
Innate's chief executive Mr Simon Wilkinson highlighted that presently there are no drugs approved to effectively treat SPMS. "Following the success of our phase IIA trials, where the data showed 80 percent of the patients had at least a 30 percent (or greater) improvement in at least one measure of MS related clinical status, we have attracted interest from both pharmas and investors," he said.
Innate is now looking to convert this interest into funding for a larger randomized phase IIB clinical trial. Meanwhile patent applications for MIS416 have been filed in other major markets including Europe, UK and Australia.
In parallel with the planning for the IIB study, Innate has expanded its NZ compassionate use access programme to allow 12 patients from the completed IIA trial to stay on treatment at the patients' request. This brings the total number of patients with progressive MS who have received MIS416 on compassionate grounds to 21.
In 15 patients with SPMS, who received six or more doses, 13 (87 percent) reported modest-to-significant improvement in their health-related quality of life. Of the seven patients who have been on treatment for 20 weeks or more, six (86 percent) report sustained improvements. MS related quality of life improvements are measured using the internationally accepted MS Quality of Life Inventory (MSQLI) assessment tool.