Heidelberg, July 22nd, 2007 - SYGNIS Pharma AG has successfully completed the clinical phase IIa-study (AXIS) in stroke. AXIS was a multicenter, doubleblind, placebo-controlled dose escalation study. The comprehensive analysis of the study data showed that the primary and secondary endpoints have been achieved and that the use of AX200 in stroke patients can be considered to be safe.
Although the focus of the AXIS-study was the collection of data regarding safety and tolerability, data regarding the efficacy of AX200 were also monitored. Due to the small number of patients involved in such a safety study, a significant difference between AX200 and placebo treated patients could not be observed in the overall consideration of the usual clinical endpoints. However, a detailed statistical evaluation of the data provided hints that certain stroke patients may benefit from a treatment with AX200.
AX200 for the treatment of acute stroke is the most advanced drug candidate in SYGNIS’ product pipeline. Besides stroke, SYGNIS is currently preclinically testing the endogenous protein AX200 in further neurodegenerative indications such as Amyotrophic Lateral Sclerosis (ALS).
With the positive results of the AXIS study the path has been cleared for the further clinical development of AX200. SYGNIS is now in the process of designing and preparing the phase IIb trial whose aim will be to demonstrate the efficacy of AX200 in stroke patients.