Date: 2011-12-15
Type of information:
phase: 2
Announcement: results
Company: Sygnis Pharma (Germany)
Product: AX200
Action
mechanism: AX200 is a biological molecule, developed by SYGNIS for the treatment of neurodegenerative diseases. In the indication stroke it is the most advanced drug candidate in SYGNIS’ product pipeline. AX200 is an endogenous protein. As part of the body\'s own protective action the production of AX200 is boosted after brain damage. If the molecule is given as a medication it increases the existing endogenous response to the damage. SYGNIS pursues a multiple neurotherapeutic approach in the development of AX200 for the treatment of neurodegenerative diseases: AX200 stops neuronal cell death in the acute phase of the disease while at the same time stimulating the regeneration of the already damaged CNS through the stimulation of neurogenesis as well as arteriogenesis and the reorganisation of neuronal networks.
Disease: acute ischemic stroke
Therapeutic area: Cerebrovascular diseases
Country:
Trial
details: 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.
Latest
news: SYGNIS Pharma AG has announced 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
NIHSS8.88
(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.
