EANS-News: SYGNIS Pharma AG / SYGNIS Announces Key Results of its Phase II Trial of AX200 in Acute Ischemic Stroke

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Research & Development

Heidelberg (euro adhoc) - SYGNIS Announces Key Results of its Phase
II Trial of AX200 in Acute Ischemic Stroke

* The Study missed its endpoints

Heidelberg, 15 December 2011 - SYGNIS Pharma AG (Frankfurt: LIOK;
ISIN DE000A1E9B74; Prime Standard) today announces 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 Mean* Relative p-value
Parameter (95% Conf. Interval) Difference*
AX200 Placebo
(n=160) (n=163)

mRS 3.31 3.12 0.19 0.30
(3.06 - 3.56) (2.87 - 3.37) (-0.17 - 0.55)

NIHSS 8.88 8.45 0.43 0.61
(7.70 - 10.07) (7.28 - 9.62) (-1.24 - 2.10)
*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.

The randomized, double-blind AXIS2 trial enrolled 328patients in
78centers 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.

"We are very disappointed about the outcome of the study and will
have to analyse the full data set in order to fully understand these
results, which are not in line with our previous findings. Although
the patient group treated with AX200 on average showed a slightly
more severe infarct; this does, however, not explain why we could not
see any relevant differences between the two groups regarding the
patient outcome ", said Dr. Frank Rathgeb, Chief Medical Officer of
SYGNIS Pharma AG.

For further information please contact:

SYGNIS Pharma AG
Dr. Franz-Werner Haas
Senior Vice President Operations
SYGNIS Pharma AG

Tel: +49 6221 454 812
Email: franz-werner.haas@sygnis.de

Media & Investors
Raimund Gabriel
Partner
MC Services

Tel: +49 89 210 2280
Email: Raimund.Gabriel@mc-services.eu

About SYGNIS Pharma AG

SYGNIS Pharma AG (Heidelberg, Germany) is a specialty drug
development company, focusing on innovative treatments for
underserved human diseases. The company's current lead program,
AX200, has completed a large Phase II efficacy trial to treat acute
ischemic stroke. In the field of cognitive disorders, the company is
exploring compounds targeting the KIBRA pathway, a novel approach to
treating different forms of dementia. With AX200 and the KIBRA
program SYGNIS is defining unique approaches to treating these very
common diseases. There is great medical demand for new treatments as
there are currently no or only inadequate options available. SYGNIS
Pharma AG is listed on the Prime Standard of the Frankfurt Stock
Exchange under the ticker: LIOK; and ISIN: DE000A1E9B74.

About AX200 AX200 is an endogenous protein (G-CSF), which - as part
of the body's own protective action- is boosted after brain damage.

About the Modified Rankin Scale The modified Rankin Scale (mRS) is a
commonly used scale for measuring the degree of disability or
dependence in the daily activities of people who have suffered a
stroke. The scale has become the most widely used clinical outcome
measure for stroke clinical trials. The scale runs from 0 to 6 - from
perfect health without symptoms to death (six).

About the National Institutes of Health Stroke Scale The National
Institutes of Health Stroke Scale (or NIHSS) is a method developed to
gauge the severity of a stroke. The score has a range between 0 and
42, the higher the score the greater the deficiencies the patient
has. Zero indicates the patient is free of symptoms.

#Disclaimer 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.

Further inquiry note:
Michael Wolf
Telefon: +49 (6221) 454 - 6
E-Mail: Michael.Wolf@sygnis.de

end of announcement euro adhoc
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company: SYGNIS Pharma AG
Im Neuenheimer Feld 515
D-69120 Heidelberg
phone: +49 (0)6221 454-6
FAX: +49 (0)6221 454-777
mail: contact@sygnis.de
WWW: http://www.sygnis.de
sector: Biotechnology
ISIN: DE000A1E9B74
indexes: CDAX, Prime All Share
stockmarkets: regulated dealing/prime standard: Frankfurt, free trade: Berlin,
Hamburg, Stuttgart, Düsseldorf, Hannover, München
language: English