In spite of an eight week delay, New Zealand-based Innate Immunotherapeutics is still planning to enroll patients for its phase 2b clinical trial that will study the experimental drug MIS416 for secondary progressive MS. The clinical research organization (CRO) involved in the management of the trial informed the company about the delay, which came as a result of agreements between clinical investigators and trial sites that have taken longer to finalize than initially anticipated.
The patient enrollment was planned for the end of June, however the CRO now expects enrollment for the trial to begin in August. Innate Immunotherapeutics will now also engage in the process of finding additional trial sites in order to accelerate the rate of appointment, as well as maximizing the rate of enrollment once each trial site has commenced treating patients. The company’s CEO, Simon Wilkinson, stated “the delay in getting trial sites established was obviously disappointing, and not just for the Company but also for the patients who have been requesting information about where and when they can apply to participate,” according to the company’s press release.
In order to continue evaluating MIS416, the trial will enroll up to 90 patients with the secondary progressive form of multiple sclerosis (SPMS) throughout Australia across eight investigational trial sites. Patients will be administrated with the drug once weekly for 12 months. 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 experimental medication has been studied at the ongoing compassionate program and revealed promising results in studies led by researchers at Victoria University of Wellington.
The study published in the PLOS ONE journal, researchers demonstrated that the drug developed originally to treat the relapsing-remitting form of MS is efficient in the treatment of secondary progressive multiple sclerosis as well. However, the research team has not fully understood what makes the therapy effective.
“We know this drug works, but we are not sure why,” explained Dr. Anne La Flamme, Associate Professor in Victoria’s School of Biological Sciences and head of the MS Research Programme at the Malaghan Institute of Medical Research. “This study has helped us understand the pathways that are driving the disease and how the medication alters the immune system, giving us a better idea of why MIS416 works as well as insight into how to treat patients and predict who will do better on this sort of medication.”
Wilkinson also said that patients with SPMS are typically highly motivated to receive continued treatment. According to the CEO, the lack of approved effective existing treatments means it is in everyone’s interest to get the trial up and running as soon as possible. The company advised that patients will have to visit the clinic every week as part of the trial.