New Zealand-based Innate Immunotherapeutics last made multiple sclerosis headlines back in February, when the company announced that its experimental drug MIS416 was found in recent studies by researchers at Victoria University of Wellington to yield promising results for those suffering with secondary progressive MS — a form of the disease that is severely lacking in viable treatment options for stifling symptoms and slowing down brain atrophy. Now, the company has announced that it is getting ready to launch a phase IIb trial of MIS416, which will once again test the drug as a therapy for secondary progressive multiple sclerosis (SPMS).
Find out more about secondary progressive MS.
According to a recent press release, Innate is beginning the recruitment process for the study in late June, and will seek to enroll up to 90 patients throughout Australia across eight investigational trial sites. The trial will be double-blinded and randomized, ensuring that 60 of the participants will receive MIS416 and the other 30 will receive a placebo. The company has also indicated that all participants will have the opportunity to to continue taking the experimental drug for treatment of their secondary progressive MS, thanks to an extension protocol.
Innate intends to utilize this new study to assess the efficacy of MIS416, and will look specifically at “clinical measures of neuromuscular function as well as patient-reported outcomes.” To measure these factors, study leaders will assess a wide range of measures, including ease of walking, eyesight, hand function, and cognition. The study will also seek to measure patients’ ability to engage in normal daily activities as well as their quality of life. Innate CEO Simon Wilkinson indicated that the strategy of considering multiple treatment outcomes will “allow us to select the right measures, and determine the correct number of patients, to take into a subsequent phase III approval trial.”
SPMS patients throughout the world continue to call for viable, new therapies for the disease. The multiple sclerosis community will continue to keep a watchful eye on how Innate’s MIS416 fares in this new study, which could yield a promising treatment option for the 2.5 million people worldwide who are affected by MS, many of which have or will develop the SPMS form of the disease.
To get more information on the trial, click here.