Evotec Reports Results of Phase II Proof-of-Concept Study with EVT 302
News Apr 20, 2009
Evotec AG has announced the results of a Phase II proof-of-concept study investigating the potential of EVT 302, a reversible and highly selective inhibitor of monoamine oxidase B (MAO-B), as an aid to smoking cessation.
EVT 302 failed to demonstrate any significant improvement in the quit rate compared with placebo. The combination of EVT 302 with a nicotine replacement patch also failed to demonstrate any significant benefit over nicotine replacement therapy (NRT) alone. The study was well performed and the placebo quit rate was well within expectations ensuring adequate power to demonstrate any treatment effect. Throughout this study EVT 302 was well tolerated with subjects experiencing very few treatment-related adverse events.
The study was performed double blind in Germany with 414 otherwise healthy smokers who were motivated to quit smoking. The study assessed whether 8 weeks treatment with EVT 302 resulted in an increase in quit rate compared to placebo. The study also included a comparison of EVT 302 added to NRT (21 mg patch once daily) vs NRT alone to see if there was any additive benefit for the two treatments taken together.
Dr Tim Tasker, Executive Vice President Clinical Development at Evotec, commented: "We are disappointed with the results of this proof-of-concept study which has failed to demonstrate any convincing support for the use of EVT 302 as an aid to smoking cessation. Once a full analysis of all the data is completed Evotec will re-assess the future of EVT 302, given the overall potential of MAO-B-inhibitors in a number of indications and the excellent safety profile demonstrated by EVT 302 in this study."
Dr Werner Lanthaler, Chief Executive Officer of Evotec, added: “Strict cost containment by focusing our pipeline and de-risking our business according to the “Evotec 2012 – Action Plan to Focus and Grow” is the right strategy also in light of this clinical outcome.”