Innate Immunotherapeutics (ASX:IIL) has confirmed the clinical phase of the Phase 2B trial of MIS416 in patients with secondary progressive multiple sclerosis (SPMS) will be completed by the end of April as scheduled.
Innate is conducting an exploratory double blinded, 2:1 randomised, placebo controlled study into the safety and efficacy of the its drug candidate MIS416 when administered once weekly over a twelve month period.
Ninety three patients with SPMS have been enrolled in the study between late 2014 and April 2016. The final sixteen patients will complete the study over the next eight weeks with the last patient scheduled to complete their last study visit on 19 April.
To date no safety related concerns have arisen during the study, said the company. It added the independent Data Safety Monitoring Board, which is responsible for periodically reviewing trial safety data, has met on three occasions as required by their charter and has expressed no concerns regarding the conduct or safety outcomes of the trial.
Following the final patient visit, the company said it expects it will take up to four months to complete the entry, monitoring, and analysis of the large amount of data the study has generated.
Innate said it continues to receive a high level of interest from the majority of patients who have already completed the trial and who want post-study access to MIS416.
According to CEO Simon Wilkinson, “The participants in this study endure a wide range of MS related debilitating symptoms and we deeply appreciate the commitment and fortitude with which so many of them have adhered to the requirements of what is an intensive course of treatment and tests over a 52 week period.”