Orexigen Therapeutics CEO Discusses Q2 2012 Results - Earnings Call Transcript

Since the last update, we have activated an additional 90 sites. And our prediction that we would achieve our enrollment goal in the first quarter of next year was predicated on the expectation that recruitment would slow down from the initial surge of patients. To date, enrollment has not slowed down, although we are not yet ready to update guidance on when enrollment will be complete.

Expedited enrollment does pull forward the time to interim analysis, which is planned once at least 87 MACE end points have been adjudicated. Exactly when the 87th MACE end point will occur is based on two key variables. The number of months of observation time for randomized subjects, and the actual observed annualized MACE rate. Using an assumption of 1.5% annualized MACE, we would need approximately 70,000 months of observation time. To date, we know enrollment rates and therefore have a pretty good idea of observation time in the randomized phase of the trial.

In order to accurately predict the time of the 87th event in the interim analysis that follows, we would also need to wait until the date a monitoring committee guides us on event rates to know how we are tracking. We would not expect to have a good estimate on event rate until enough end points have occurred to make a solid projection.

For now, we feel comfortable with our guidance that the 87th event will occur sometime in the second half of next year. According to the extensive epidemical modeling we've conducted, the population we are targeting would yield an event rate of approximately 2%. But because patients in clinical trials typically experience a slightly lower event rate than the models would predict, we based our assumptions on an estimate of 1.5% annualized mix.

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