Orexigen Therapeutics, a La Jolla, Calif.-based biopharmaceutical company focused on the treatment of obesity, now expects to complete enrollment of patients required for the interim analysis of the Light study in the first quarter of 2013, potentially reducing original projections by half.
"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 MACEs have been adjudicated, Orexigen will conduct an interim analysis. Orexigen plans to resubmit Contrave’s 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.
"We are excited that the innovative tactics we are employing to enroll the Light study are already paying dividends in the speed of recruitment of patients with the targeted MACE risk profile," said Dr. Preston Klassen, senior vice president and head of development, Orexigen. "While a number of factors contribute to the overall timing of event-driven trials, it is very encouraging that we have attracted so many patients into the study this quickly. If this rate continues, we should dramatically exceed our original enrollment goals."