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Evotec Reports Start of Phase II Proof-of-Concept Quit Rate Study with EVT 302 and Results of Craving Study
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.
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