SYGNIS' AX200 shows efficacy in stroke patients
Phase IIa results exceed expectations
Wolf-Rüdiger Schäbitz, MD, principal investigator of the SYGNIS AXIS study, using AX200 for the treatment of acute ischemic stroke, presented an expert analysis of the Phase IIa results. AX200 was found to be safe and revealed efficacy in stroke patients. The in-depth analysis of the study data demonstrated evidence that, in particular, patients with severe strokes could benefit from AX200 treatment. Currently, more than 5 million strokes happen worldwide every year. This number increases constantly due to demographic factors. Stroke is the third leading cause of death, presenting a major socioeconomic burden.
AXIS (AX200 in Acute Ischemic Stroke) was a double-blinded, placebo-controlled study, conducted in Germany (Münster, Leipzig, Heidelberg, Hamburg, Wiesbaden and Erlangen). 44 patients were enrolled in the trial, of which 30 were treated with AX200 and 14 received placebo.
Two months ago, the company already reported that AX200 was safe and well tolerated in stroke patients, and continued analysis of the study data. AXIS was designed to evaluate safety and to monitor multiple dimensions of stroke outcome, including clinical, as well as imaging (Magnetic Resonance Imaging) parameters. All primary and secondary endpoints of the study were achieved.
To advance AX200 towards the market, the drug will be studied in a further clinical trial to define the maximal benefit for stroke patients.
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