SAN DIEGO, Sept. 5, 2012 -- Orexigen Therapeutics, Inc. (Nasdaq: OREX) today announced an update to the projected timeframe for enrollment of patients in the Light Study, the cardiovascular outcomes clinical trial evaluating Contrave(naltrexone SR/ bupropion SR). Enrollment into the study has continued without abatement at a rate faster than originally expected, with more than 4,500 patients enrolled as of August 31. Orexigen now expects to close enrollment to new patients in the fourth quarter of 2012.
The primary endpoint of the Light Study is the time to occurrence of major adverse cardiovascular events (MACE) during randomized treatment for Contrave compared to placebo. After at least 87 MACE have been adjudicated, the study's independent Data Monitoring Committee will conduct an interim analysis. If the interim analysis excludes a doubling of risk of MACE in patients receiving Contrave compared to placebo, Orexigen plans to resubmit the Contrave New Drug Application (NDA) to the United States Food and Drug Administration (FDA) for approval. The exclusion of a doubling of risk of MACE was established as the threshold for approvability of Contrave during discussions with the FDA prior to the start of the Light Study.
"By successfully expediting patient enrollment into the Light Study, we are executing on our promise to shareholders to do what we can to pull forward the time to the interim analysis," said Michael Narachi, CEO of Orexigen.
"The other key information needed to determine the timing of the interim analysis is the rate of MACE in the study, which is still too early to know," Narachi continued. "Importantly, because the demographics of the patient population entering the study are in line with our targets for age, gender, race, smoking status, prevalence of cardiovascular disease and other co-morbidities, we remain confident that we will have the requisite number of events needed to conduct the interim analysis in 2013. We would expect to update investors with a more precise estimate of the timing of the interim analysis after we have received sufficient information about the rate of events from the Data Monitoring Committee."
As a result of the successful acceleration of enrollment, some expenses associated with the Light Study will shift from 2013 into 2012. Accelerating enrollment does not result in a change to the Company's guidance that current cash, cash equivalents and marketable securities will last through the anticipated timing of the resubmission of the Contrave NDA.
