Compassionate Use Trial of Innate Immunotherapeutics’ Multiple Sclerosis Drug Shows Positive Results

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 treatment resources to fight the secondary progressive type of the disease.

Innate enrolled 24 MS patients in the trial, 15 of which had already participated in the Phase 1B and 2A trials of the drug. Out of the total patients being studied, 18 have SPMS and the other six suffer from a rarer primary progressive form of multiple sclerosis. Patients have been treated with the drug for 24 months, on average, receiving a median of 52 doses.

Although the new results cannot prove the safety or efficacy of MIS416 yet, the trial results can provide new insights into the course of treatment. According to the regular safety blood tests performed, the patients are able to receive weekly or fortnightly injections of MIS416 on a long-term and continuous basis, and there was no significant dose intolerance or cumulative toxicity reported.

SPMS causes walking, hand, eyesight and cognitive function disabilities, all of which are part of the study’s aim to test the viably of MIS416 as a treatment for Secondary Progressive MS. As part of the study, patients also reported their own health status quarterly, as the results have shown significant and sustained reductions in pain and fatigue.

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The results of the trial may also aid Innate in future patient recruitment for the Phase 2B of the study.

Opexa Therapeutics, a Texas-based drug delivery company, is also developing a breakthrough T-cell immunotherapy for the treatment of SPMS. Tcelna has already reached its Phase 2B clinical trial, which is currently being conducted in 35 select clinics across the U.S. and Canada. Each patient will receive two yearly treatment courses of Tcelna composed of five subcutaneous injections, and researchers will measure the brain volume changes at the end of 24 months.