MIS416 is microparticle derived from bacteria, combined with two immune-modifying molecules. It acts to stimulate a specific range of responses in the innate immune system.
The results of the Phase Ib/IIa clinical trial as well as work in laboratory models of MS has now been published in the international scientific journal PLoS One (click here to read the abstract).
MIS416 was initially used to treat people with secondary progressive MS outside of a formal clinical trial under compassionate use legislation in New Zealand. Following positive results from these treatments, researchers ran a Phase Ib/IIa clinical trial to formally test safety, tolerability and initial impact. The clinical trial, also run in New Zealand, included 19 people with secondary progressive MS. Four escalating doses of MIS416 were given once weekly as intravenous infusions.
MIS416 was tolerated well with only minor expected side effects such as fever, headache, fatigue and muscle pain or stiffness. Participants did not have any worsening of clinical status, with no new lesions seen on magnetic resonance imaging (MRI) or enhancements of existing lesions over the 12 weeks of the trial.
The research also looked at how MIS416 worked in laboratory models of MS to determine the exact mechanism underlying its potential as a therapy for MS. In this work, the researchers showed MIS416 acted via changing the immune cell balance and suppressing the development of pro-inflammatory Th1, Th2 and Th17 immune cells. MIS416 also increased the level of a signalling molecule called interferon-gamma. The increase in blood levels of interferon-gamma was also seen in the people treated with MIS416 in the clinical trial. While interferon-gamma is traditionally known to increase inflammation, it is also capable of regulating immunity and it is this capacity that seems to be an essential part of how MIS416 worked.
Based on these results, Innate Therapeutics is now planning a further Phase IIb clinical trial which will measure the potential effectiveness of MIS416 as a therapy. This trial will have some sites in Australia, however the sites are not finalised and recruitment is yet to begin. MS Research Australia will post information about the new clinical trial on our MS clinical trials website as it becomes available. Alternatively, please see the Innate Therapeutics website for more information.