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Evotec AG (OJ:EVT) Corporate news announcement processed and transmitted by Hugin ASA. The issuer is solely responsible for the content of this announcement. ---------------------------------------------------------------------- --------------
Hamburg, Germany - Evotec AG (Frankfurt Stock Exchange: EVT; NASDAQ: EVTC) announced today the start of the Phase II proof-of-concept study, investigating the effect of EVT 302 on the quit rate of patients who want to stop smoking. The Company also provided an analysis of the results of its exploratory Phase II craving study of the same compound. EVT 302 is a reversible and highly selective inhibitor of monoamine oxidase B (MAO-B).
The completed double-blind, placebo controlled, cross-over craving study was designed to investigate the acute effect of EVT 302 alone and in combination with nicotine replacement therapy (NRT) on craving and withdrawal symptoms after short-term deprivation of cigarettes in 90 smokers. On the day before short-term abstinence from smoking, smokers received either a single dose of EVT 302 or placebo matching EVT 302. On the next day, at the start of the 12-hour smoking deprivation phase, the subjects received additionally either NRT or corresponding placebo (i.e. subjects received either placebo only, or NRT only, or EVT 302 only, or NRT plus EVT 302). This was an exploratory study to investigate a potential short-term role of MAO-B inhibition in improving signs of withdrawal, but was also intended to help the design of the Phase II proof-of-concept study, announced today, on the absolute quit rate, the endpoint of clinical and regulatory significance.
Results from the craving study confirmed that EVT 302 was well tolerated in all patients. As expected, NRT reduced craving during the period of abstinence more than placebo. EVT 302 alone showed no acute effect on craving compared to placebo, and there was no statistically significant difference between the combination of NRT and EVT 302 and NRT alone. Regarding other withdrawal symptoms, smoking cessation was associated with moderate deterioration in psychomotor function & attention. The amelioration of this deterioration by NRT was facilitated by EVT 302.
The just announced quit rate study is intended to provide the proof-of-concept for the efficacy of EVT 302 in smoking cessation, and, in addition, provide data on a potential useful interaction between EVT 302 and NRT. In this multi-centre, double-blind, parallel group design study, the effectiveness and safety of EVT 302 once daily on its own and in combination with NRT compared to placebo will be investigated in 400 smokers.
"We are pleased to announce the start of the Phase II quit rate study following approvals by the Ethics Committee and by the German central regulatory authority BfArM. Based on published research of other MAO-B inhibitors in quit rate studies, we believe that EVT 302 will improve quit rates in this longer term smoking cessation study and plan to confirm initial signals for a potentially useful interaction between EVT 302 and NRT," commented Dr Tim Tasker, Executive Vice President Clinical Development at Evotec.
Forward-Looking Statements Information set forth in this press release contains forward-looking statements, which involve a number of risks and uncertainties. Such forward-looking statements include, but are not limited to, statements about our expectations and assumptions concerning regulatory, clinical and business strategies, the progress of our clinical development programs and timing of the results of our clinical trials, strategic collaborations and management's plans, objectives and strategies. These statements are neither promises nor guarantees, but are subject to a variety of risks and uncertainties, many of which are beyond our control, and which could cause actual results to differ materially from those contemplated in these forward-looking statements. In particular, the risks and uncertainties include, among other things: risks that product candidates may fail in the clinic or may not be successfully marketed or manufactured; risks relating to our ability to advance the development of product candidates currently in the pipeline or in clinical trials; our inability to further identify, develop and achieve commercial success for new products and technologies; competing products may be more successful; our inability to interest potential partners in our technologies and products; our inability to achieve commercial success for our products and technologies; our inability to protect our intellectual property and the cost of enforcing or defending our intellectual property rights; our failure to comply with regulations relating to our products and product candidates, including FDA requirements; the risk that the FDA may interpret the results of our studies differently than we have; the risk that clinical trials may not result in marketable products; the risk that we may be unable to successfully secure regulatory approval of and market our drug candidates; and risks of new, changing and competitive technologies and regulations in the U.S. and internationally. The list of risks above is not exhaustive. Our Annual Report on Form 20-F, filed with the Securities and Exchange Commission, and other documents filed with, or furnished to the Securities and Exchange Commission, contain additional factors that could impact our businesses and financial performance. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any such statements to reflect any change in our expectations or any change in events, conditions or circumstances on which any such statement is based.
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Evotec AG Schnackenburgallee 114 Hamburg Germany
WKN: 566480; ISIN: DE0005664809 ; Index: Prime All Share, CDAX, HDAX, MIDCAP, TECH All Share; Listed: Geregelter Markt in Frankfurter Wertpapierbörse, Prime Standard in Frankfurter Wertpapierbörse, Freiverkehr in Börse Berlin, Freiverkehr in Bayerische Börse München,
Freiverkehr in Börse Düsseldorf, Freiverkehr in Börse Stuttgart,
Freiverkehr in Hanseatische Wertpapierbörse zu Hamburg, Freiverkehr in Niedersächsische Börse zu Hannover;
