Microparticle Immune Stimulator 416 (MIS416) is a novel therapeutic that has shown potential as a treatment for secondary progressive multiple sclerosis (SPMS). It has been developed by Innate Immunotherapeutics Limited (IIL), a biotech company based in Australia and New Zealand. In September, 2015, MStranslate travelled to New Zealand to learn more about this new drug, its history and the clinical trial currently being undertaken to further test its safety and efficacy. To begin our visit, we met with Simon Wilkinson (CEO, IIL). In this short video, filmed during our meeting, Simon discusses the journey that was taken for the discovery of MIS416 and explains how they’ve reached the point they’re at today. To better understand the history of MIS416, we went back and reviewed previous studies completed on it. The outcomes of these investigations were published as two separate articles prior to the commencement of the current Phase 2b trial. In the first, the results of the Phase 1 / Phase 2a trials were reported, including the safety, tolerability and dose profile for MIS416. The second examined the mechanism of action of MIS416, using both a mouse model of MS (EAE) and results from the earlier clinical trials. The theory behind this treatment is the idea that progression in SPMS occurs due to exhaustion of the innate immune system. MIS416 is a microparticle derived from a bacteria (shown here) that aims to turn on regulatory components of the innate immune system. Treatment of EAE mice with MIS416 was shown to alter the types of T cells present and decrease the amount of Th1 and Th17 T cells that are known to be important in autoimmunity (as discussed last week). As well as this, MIS416 lead to an increase in the production of an immune signalling molecule, known as interferon-gamma, which led to disease reduction in the mice. This increase in interferon-gamma was also observed in people with SPMS that received MIS416. Together, these results provide evidence that MIS416 may have benefits for people with SPMS by altering the immune response and reducing inflammation in the central nervous system. The full text of the article referenced can be viewed here. The science behind MIS416 is explained in more detail below in an interview with the lead scientist behind it’s development, Dr Gill Webster. Dr Webster comments on the differences between RRMS and SPMS, explains how SPMS is targeted by MIS416 and outlines the benefits observed in preliminary trials for people with SPMS. Having achieved a better understanding of the science behind MIS416, we also felt it important to capture the personal experiences of people living with MS that have received the drug. Our first discussion was with Nick, an artist, who spends his days painting at a shared art space in Auckland. He has been diagnosed with SPMS. Since April 2015, Nick has been receiving MIS416 under New Zealand’s compassionate use program. During our time together he shared with us his experiences of living with MS and the changes he has observed since he started treatment. Shifting our focus back to the clinical trial currently underway, we thought it important to provide an insight into the participation process. To help with this, we met with Jo Kepple, who was the clinical study co-ordinator for the preliminary trials on MIS416 and the primary point of contact for participants. In this video, Jo describes the screening procedure in place and explains what people with SPMS can expect if they decide to enter the trial. Our visit to New Zealand finished with one final discussion with IIL CEO, Simon Wilkinson. During our first discussion above, Simon spoke of the journey that was taken in the development of MIS416 to contextualise the present day status of the project. In our follow up discussion, Simon shared the preliminary data that has been received from early clinical trials and from people on the compassionate use program in New Zealand. Early results have shown that 75% of people with SPMS have experienced benefits from receiving MIS416 and that a majority of those people have reported significant improvements in a number of symptoms, such as pain and fatigue. If you would like to find out more information about how you can participate in the trial, visit www.mstrial.com.au, where you will also find the contact details for your closest trial centre. We hope you have enjoyed this insight into MIS416 and its potential benefits for people living with SPMS. Please don’t hesitate to contact us if you have any questions. ADDITIONAL FEATURES To further personalise the experience of participating in the MIS416 clinical trial, we recently published a video we filmed with Karen, who lives in Christchurch. Karen talked to us about her experience with MS (including the progression to SPMS), how it has changed her life, and the results she has seen since being part of the MIS416 trial. Our latest information indicates that Innate Immunotherapeutics have now reached their registration target for the MIS416 trial. However, sites are continuing to enrol and the recruiment period has now been extended until the end of March 2016. If you are interested or have any further questions about this trial, please don’t hesitate to ask. More information can also be found at www.mstrial.com.au. ADDITIONAL CONTENT Since our Feature Week on Innate Immunotherpaeutics and the development of MIS416, we’ve featured one additional video where members of the New Zealand MS community have shared their experiences of being on the treatment. We thank Gillian, Stephen and Mary for taking the time to share their stories with us.
