SYGNIS' AX200 Shows Efficacy in Stroke Patients - Phase IIa Results Exceed Expectations


HEIDELBERG, Germany, September 17 /PRNewswire/ --

- AXIS Study Group Presented Safety and Efficacy Data at German
Neurological Society Congress in Berlin

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.

Some statements included in this press release, relating
neither to proven financial results nor other historical data, should be
viewed as forward-looking, i.e. not definite. Such statements are mainly
predictions of future results, trends, plans or goals. These statements
should not be considered to be total guarantees since given their very nature
they are subject to known and unknown risks and imponderability and can be
affected by other factors as a consequence of which the actual results, plans
and goals of SYGNIS Pharma AG may deviate greatly from the established
conclusions or implied predictions contained in such statements. SYGNIS does
not undertake to publicly update or revise these statements in the light of
new information or future results or for any other reason.

For more information, please contact:

    Dr. Franz-Werner Haas
    Vice President Operations
    +49-(0)-6221-454-812
    franz-werner.haas@sygnis.de

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