Sygnis’ AX200 shows efficacy in stroke patients – Phase IIa results exceed expectations
AXIS study group presented safety and efficacy data at German Neurological Society Congress in Berlin
HEIDELBERG, September 17, 2007 – 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 socio-economic burden.
“We are pleased that the AXIS study provides such promising data. We look forward towards the further development of this drug candidate to hopefully become an efficacious treatment option for our stroke patients who are in high need for better therapies. I am excited that, after a series of disappointing results of other stroke trials, we seem to have a promising agent for the many patients suffering stroke”, said Professor Erich Bernd Ringelstein, Chairman of the Scientific Advisory Board of the German Stroke Foundation and member of the Executive Committee of the German Stroke Society.
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.
“It is rewarding that we have been able to translate our discoveries from bench to bedside. We are delighted that AXIS exceeded our expectations, showing beneficial effects in stroke patients. AX200, which seemingly supports the body’s endogenous protective and regenerative response, has broad potential to become a promising drug also beyond acute stroke. Capitalizing on the vast therapeutic potential of AX200, SYGNIS pursues additional indications of the compound, such as rehabilitation after stroke, in order to exploit the full market potential of this drug candidate”, said Alfred Bach, CEO of SYGNIS.
About SYGNIS Pharma
SYGNIS Pharma AG, with head offices in Heidelberg, is a specialty pharmaceutical company listed on the Prime Standard of the German stock exchange (LIO, WKN 504350). The company is focused on the research, development and marketing of innovative therapies for the treatment of neurodegenerative diseases. These include Stroke, Amyotrophic Lateral Sclerosis (ALS), Huntington's Disease and neurological disorders resulting from injury, such as trauma of the brain or the spinal cord. All of these disorders are characterized by the fact that, as the disease progresses, nerve cells are damaged and die. Although there is great medical demand, there are currently no or only inadequate treatment options available.
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Posted: September 2007