SAN DIEGO, July 11, 2012 /PRNewswire/ -- 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.
"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. "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."
About Orexigen Therapeutics Orexigen Therapeutics, Inc. is a biopharmaceutical company focused on the treatment of obesity. The Company's lead product candidate is Contrave, which has completed Phase III clinical trials and for which a New Drug Application has been submitted and reviewed by the FDA. The Company has also reached agreement with the FDA on a Special Protocol Assessment (SPA) for the Light Study, the Contrave cardiovascular outcomes trial. The Company's other product candidate, Empatic™, has completed Phase II clinical trials. Further information about the Company can be found at www.orexigen.com.
Forward-Looking Statements Orexigen cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements. Words such as "believes," "anticipates," "plans," "expects," "indicates," "will," "intends," "potential," "suggests," "assuming," "designed" and similar expressions are intended to identify forward-looking statements. These statements are based on the Company's current beliefs and expectations. These forward-looking statements include statements regarding the timing of enrollment and MACE events in the Light Study; the ability to enroll the targeted patient population; the ability to activate sites and conduct the Light Study; the potential for, and timing of, the accrual of MACE events and the potential resubmission of the Contrave NDA; the safety and effectiveness of Contrave; and the potential for, and timing of, approval for Contrave. The inclusion of forward-looking statements should not be regarded as a representation by Orexigen that any of its plans will be achieved. Actual results may differ from those set forth in this release due to the risk and uncertainties inherent in the Orexigen business, including, without limitation: the Special Protocol Assessment (SPA) is not binding on the FDA if public health concerns unrecognized at the time the SPA agreement was entered into become evident, other new scientific concerns regarding product safety or efficacy arise, or if Orexigen fails to comply with the agreed upon trial protocol; Orexigen's ability to conduct the Light Study and the progress and timing thereof, including risks associated with recruiting and enrolling patients in the Light Study; Orexigen's ability to demonstrate in the Light Study that the risk of MACE in overweight and obese subjects treated with Contrave does not adversely affect the product candidate's benefit-risk profile; the potential that earlier clinical trials may not be predictive of future results in the Light Study; the potential for the FDA to not approve Contrave even after the resubmission with the MACE event data; the potential for early termination of the collaboration agreement between Orexigen and Takeda; the costs and time required to complete additional clinical, non-clinical or other requirements prior to any resubmission of an NDA; the therapeutic and commercial value of Contrave; Orexigen's ability to maintain sufficient capital; and other risks described in the Company's filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Orexigen undertakes no obligation to revise or update this news release to reflect events or circumstances after the date hereof. Further information regarding these and other risks is included under the heading "Risk Factors" in Orexigen's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission May 10, 2012 and which is available from the SEC's website (www.sec.gov) and on Orexigen's website (www.orexigen.com) under the heading "Investor Relations." All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.
Media Contact: McDavid Stilwell
Denise PowellVP, Corporate Communications and Business Development
|SOURCE Orexigen Therapeutics, Inc.|
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