HAMBURG, Germany and OXFORD, England, January 7 /PRNewswire-FirstCall/ -- Evotec AG (Frankfurt Stock Exchange: EVT) today announced that it has successfully completed a Phase I safety and tolerability study with EVT 302. The preliminary results confirm the good tolerability profile of EVT 302 and are an encouraging basis for further clinical development.
EVT 302, a reversible and highly selective inhibitor of MAO-B in development for smoking cessation, was investigated in an ascending dose study with repeated daily dosing in a total of 84 healthy young and elderly subjects. Healthy young male subjects were treated with EVT 302 2.5, 5, 15 mg, or placebo for two weeks, and healthy elderly male and female subjects were treated with EVT 302 2.5 mg, 10 mg, or placebo for four weeks. Each treatment was received by 12 young and/or elderly subjects as appropriate. The highest dose levels exceed the expected maximum therapeutic dose planned to be used in further clinical trials. For the treatment period and part of the subsequent washout phase the subjects were confined to the clinical research unit.
The study was aimed at investigating safety/tolerability, pharmacokinetics, and pharmacodynamics (inhibition of MAO-B in platelets) during prolonged dosing with EVT 302 as compared to placebo. The study was conducted and successfully completed as planned per protocol. The results are still blinded and will become available as final evaluated data over the next two months.
The preliminary data indicate that EVT 302 was well tolerated in young and elderly subjects up to the highest dose levels tested in this study. Adverse events (AEs) classified as possibly treatment related were transient and mostly of mild intensity; only very few moderate AEs were reported. No severe or serious AEs occurred.
No clinically relevant changes in lab values of haematology or clinical chemistry were noted. In particular, there were no changes in liver function tests, in any subjects.
About EVT 302
EVT 302 is an orally active, potent, highly selective and reversible inhibitor of MAO-B in development for smoking cessation. Its preclinical profile supports the potential for a superior safety profile over marketed MAO-B inhibitors and better tolerability compared to current treatments. In a Phase I single ascending dose study at Roche from whom the compound was in-licensed, EVT 302 was safe and well tolerated up to high dose levels and showed excellent pharmacokinetic properties with prolonged MAO-B inhibition offering the potential for once a week dosing at very low exposure levels. This could be a significant advantage for a condition where smokers' motivation for quitting can vary from day to day.
Two further Phase I studies with EVT 302 are currently ongoing: In March 2007, Evotec initiated a positron emission tomography (PET) study designed to assess the occupancy of MAO-B in the brain after the oral administration of EVT 302 in patients. This technique helps to determine the therapeutic dose range of EVT 302 for subsequent safety and efficacy studies. The study is expected to be completed in early 2008.
In November 2007, Evotec initiated a Phase I tyramine interaction study to confirm that there was no cardiovascular liability with foods that contain high amounts of tyramine. A first Phase II study to examine the effects of EVT 302 on craving following smoking cessation is planned to start in Q1 2008.
About Smoking Cessation
The market potential for smoking cessation therapies is enormous. There are 44.5 million smokers in the US alone, 70% of which report a desire to quit, and the average smoker will make six to nine attempts to quit during their lifetime. There is also strong health economic support for the benefits of quitting. The market is dominated by nicotine replacements such as patch and gum, and only two prescription therapies are currently approved. Any drug that could improve smoking cessation rates could have a good opportunity for a quick market penetration and provide an additional treatment tool for physicians.
Forward looking statements
Information set forth in this report contains forward-looking statements, which involve a number of risks and uncertainties. Such forward-looking statements include, but are not limited to, statements about the anticipated benefits of Evotec's products, the timing of the completion of the transaction between Evotec and Renovis, the anticipated benefits of the business combination transaction involving Evotec and Renovis, including future financial and operating results, the combined company's plans, objectives, expectations and intentions, the anticipated timing and results of the combined company's clinical and pre-clinical programs, and other statements that are not historical facts. Evotec cautions readers that any forward-looking information is not a guarantee of future performance and that actual results could differ materially from those contained in the forward-looking information. These include risks and uncertainties relating to: the ability to obtain regulatory approvals of the transaction on the proposed terms and schedule; the parties' ability to complete the transaction because conditions to the closing of the transaction may not be satisfied; the failure to successfully integrate the businesses; unexpected costs or liabilities resulting from the transaction; the risk that synergies from the transaction may not be fully realized or may take longer to realize than expected; disruption from the transaction making it more difficult to maintain relationships with customers, employees or suppliers; competition and its effect on pricing, spending, third-party relationships and revenues; the need to develop new products and adapt to significant technological change; implementation of strategies for improving internal growth; use and protection of intellectual property; general worldwide economic conditions and related uncertainties; future legislative, regulatory, or tax changes as well as other economic, business and/or competitive factors; and the effect of exchange rate fluctuations on international operations.
The risks included above are not exhaustive. The most recent reports on Form 10-K, Form 10-Q, Form 8-K and other periodic reports filed by Renovis with the Securities and Exchange Commission contain additional factors that could impact the combined company's businesses and financial performance. The parties expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any such statements to reflect any change in the parties' expectations or any change in events, conditions or circumstances on which any such statement is based.
Renovis has filed a Current Report on Form 8-K that includes as an exhibit the Agreement and Plan of Merger between Evotec and Renovis. Evotec has filed a Registration Statement on Form F-4 with the Securities and Exchange Commission in connection with the proposed merger. Evotec and Renovis expect to mail a joint proxy statement/prospectus, which will form part of the Registration Statement on Form F-4, to shareholders of Renovis in connection with the proposed merger. This document will contain important information about the merger and should be read before any decision is made with respect to the merger. Investors and stockholders will be able to obtain free copies of this document and any other documents filed or furnished by Evotec or Renovis through the website maintained by the Securities and Exchange Commission at http://www.sec.gov. Free copies of these documents may also be obtained from Evotec, by directing a request to Evotec's Investor Relations department at Schnackenburgallee 114, 22525 Hamburg, Germany, or from Renovis, by directing a request to Renovis' Investor Relations department at Two Corporate Drive, South San Francisco, California 94080.
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SVP, Investor Relations & Corporate Communications
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