SYGNIS Announces Key Results of its Phase II Trial of AX200 in Acute Ischemic Stroke
• The Study missed its endpoints
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.
Clinical Parameter Mean *
(95% Conf. Interval) Relative Difference* p-value
AX200 (n=160) Placebo
(n=163)
mRS 3.31
(3.06 - 3.56) 3.12
(2.87 - 3.37) 0.19
(-0.17 - 0.55) 0.30
NIHSS 8.88
(7.70 - 10.07) 8.45
(7.28 - 9.62) 0.43
(-1.24 - 2.10) 0.61
*adjusted for pre-specified baseline characteristics
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.
The randomized, double-blind AXIS 2 trial enrolled 328 patients in 78 centers throughout Europe. Patients enrolled into AXIS 2 had to meet basic inclusion criteria of treatment within nine hours after stroke onset; ischemic stroke in the MCA territory confirmed by MRI; an NIHSS recording of 6 - 22 and stroke size of more than 15cm³.
"We are very disappointed about the outcome of the study and will have to analyse the full data set in order to fully understand these results, which are not in line with our previous findings. Although the patient group treated with AX200 on average showed a slightly more severe infarct; this does, however, not explain why we could not see any relevant differences between the two groups regarding the patient outcome ", said Dr. Frank Rathgeb, Chief Medical Officer of SYGNIS Pharma AG.