SYGNIS starts Phase II efficacy trial of AX200 for the treatment of acute ischemic stroke
SYGNIS Pharma AG announced that it has started a multinational phase II efficacy trial of its lead compound, AX200, for the treatment of acute ischemic stroke (AXIS 2).
After obtaining all regulatory and ethics committee approvals, the first study centre has been initiated in Austria. Centres in Germany, Belgium, Spain, the Czech Republic, Slovakia and Sweden are planned to follow shortly. Overall about 65 centres are planned to take part in the AXIS 2 study. Enrolment is scheduled to take approximately 18 months and the first results are expected about 6 months thereafter.
The randomized, double-blind trial will enrol 350 patients assigned to two groups, one AX200 group and one placebo group, with 175 patients each. The goal of AXIS 2 is to assess the efficacy of AX200 compared to placebo in patients suffering from acute ischemic stroke. Patients will be enrolled up to nine hours after occurrence of an ischemic stroke and treatment will be administered as an infusion for 3 days.
The primary endpoint of the AXIS 2 trial is patient outcome evaluated using the modified Rankin Scale (mRS) which is the universal standard clinical scale for measuring global functioning of stroke patients. Secondary endpoints include further clinical scales for functional ability on one hand, and safety as well as imaging technology to assess changes in infarct size on the other hand.
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