ASX RELEASE 28 February 2017
Phase 2B trial of MIS416 in patients with secondary progressive multiple
sclerosis on schedule to complete by end of April 2017
Innate Immunotherapeutics Limited (ASX Code: IIL) confirms that 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 Company's drug candidate MIS416 when administered once weekly
over a twelve month period. Ninety three patients with SPMS have been enrolled into 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. 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 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. Each patient
generates approximately 400 pages of data over the full course of the study. The final Clinical Study
Report should be released in late August or during September. Initial 'topline' data may become
available prior to the release of the final report and if so, this will be released to the market at that
time.
The Company 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. The Company is working
closely with the patients’ general practitioners to ensure that such access can be arranged whenever
possible.
CEO Simon Wilkinson commented, “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.”
