Orexigen (OREX) Sees Enrollment for Contrave Light Study Going Faster than Expected
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Orexigen Therapeutics, Inc. (Nasdaq: OREX) today announced an update to the projected timeframe for completion of enrollment of the Light Study, the Contrave cardiovascular outcomes clinical trial. Orexigen now expects to complete enrollment of patients required for the interim analysis of the Light Study in the first quarter of 2013, potentially reducing by half the original projections.
"2012 has been a year of focused execution at Orexigen in order to conduct the Light Study as quickly as possible," said Michael Narachi, CEO of Orexigen. "The outstanding efforts of our team and our partners have resulted in enrollment rates of the targeted population that are much faster than originally expected."
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 approximately 87 MACE have been adjudicated, Orexigen will conduct an interim analysis. Orexigen plans to resubmit the Contrave New Drug Application for approval if in the interim analysis the company is able to exclude a doubling of risk of MACE in patients receiving Contrave compared to placebo.
Orexigen is targeting to enroll a patient population with a 1.5% annualized background rate of MACE. The demographics (age, gender, smoking status, prevalence of cardiovascular disease, diabetes and other co-morbidities) of the patients enrolled into the study to date are in line with the targeted population and the projected MACE rate.
Since initiation of the Light Study at the beginning of June, over 1,500 patients have been enrolled into the study at approximately 100 sites that have been activated thus far. The remaining 200 sites are scheduled to be activated by the end of August. With the revised enrollment projections, and assuming that the actual background MACE rate meets the expected 1.5% per year, the 87th MACE would occur in the second half of 2013.
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"2012 has been a year of focused execution at Orexigen in order to conduct the Light Study as quickly as possible," said Michael Narachi, CEO of Orexigen. "The outstanding efforts of our team and our partners have resulted in enrollment rates of the targeted population that are much faster than originally expected."
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 approximately 87 MACE have been adjudicated, Orexigen will conduct an interim analysis. Orexigen plans to resubmit the Contrave New Drug Application for approval if in the interim analysis the company is able to exclude a doubling of risk of MACE in patients receiving Contrave compared to placebo.
Orexigen is targeting to enroll a patient population with a 1.5% annualized background rate of MACE. The demographics (age, gender, smoking status, prevalence of cardiovascular disease, diabetes and other co-morbidities) of the patients enrolled into the study to date are in line with the targeted population and the projected MACE rate.
Since initiation of the Light Study at the beginning of June, over 1,500 patients have been enrolled into the study at approximately 100 sites that have been activated thus far. The remaining 200 sites are scheduled to be activated by the end of August. With the revised enrollment projections, and assuming that the actual background MACE rate meets the expected 1.5% per year, the 87th MACE would occur in the second half of 2013.
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