EANS-News: SYGNIS Pharma AG
SYGNIS Announces Key Results of its Phase II Trial
of AX200 in Acute Ischemic Stroke
15.12.2011 – 21:13
-------------------------------------------------------------------------------- Corporate news transmitted by euro adhoc. The issuer/originator is solely responsible for the content of this announcement. -------------------------------------------------------------------------------- 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 -------------------------------------------------------------------------------- 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