SYGNIS Pharma AG announces key results of its Phase II trial of AX200 for the treatment of Acute Ischemic Stroke
Heidelberg, 15 December 2011 – SYGNIS Pharma AG (Frankfurt: LIOK; ISIN DE000A1E9B74; Prime Standard) today announces key results of the Phase II clinical trial (AXIS 2) of AX200 to treat acute ischemic stroke. The key results on the relevant primary endpoint, using the modified Rankin Scale (mRS), and secondary endpoint, using the National Institutes of Health Stroke Scale (NIHSS), show no improvement in patient outcome relative to the placebo-treated patient. As a result, the study missed its endpoints.
The primary endpoint of significant functional improvement according to mRS evaluated AX200 treated patients relative to placebo-treated patients. The study recorded no clinical improvement and did not show any statistically significant difference. The secondary endpoint of improvement using the NIHSS relative to placebo-treated patients did also not record a clinically relevant or statistically significant difference. The randomized, double-blind AXIS 2 trial enrolled 328 patients in 78 centers throughout Europe.
SYGNIS Pharma will continue to analyse the current data set and the new data that will become available in the weeks ahead. Full data will be available in Q1 2012.
Posted: December 2011