An international phase IIB trial of a new experimental medication, known as MIS416, for secondary progressive MS has successfully completed recruitment.
The trial commenced in September 2014 and included several sites in Australia. MIS416 was developed in New Zealand by biotechnology company Innate Immunotherapeutics and is being explored as an option for the treatment of progressive MS.
MIS416 is a microparticle derived from bacteria, combined with two immune-modifying molecules. It acts to stimulate a specific range of responses in the innate immune. The innate immune system is thought to play a particularly important role in progressive forms of MS.
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 encouraging results from these treatments, the researchers tested the experimental therapy in 19 people with secondary progressive MS in a Phase Ib/IIa clinical trial to formally test safety, tolerability and to obtain pilot data on efficacy.
The results of the Phase Ib/IIa clinical trial as well as work in laboratory models of MS was published in April 2014 (read the previous MS Research Australia news article here).
Subsequently the phase IIB trial was set up to investigate the safety and efficacy of MIS416 in a larger group of people with secondary progressive MS.
The clinical trial has reached its target recruitment of over 90 participants across multiple sites in Australia and overseas. The trial is a double blinded randomised study where 60 patients will receive MIS416 and 30 will receive a placebo. MIS416 is administered by once weekly intravenous infusions with each patient remaining in the trial for 12 months.
The trial will now continue to completion, monitoring the patients currently in the trial, with results expected in the second half of 2017.
For more information, view the Innate Immunotherapeutics media release here