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|Orexigen Announces Presentation of Data for OREX-1019 and OREX-1038, Preclinical Candidates for the Treatment of Chronic Pain with Reduced Addiction Liability and the Treatment and Management of Opioid Drug Addiction|
The two presentations highlight the preclinical efficacy and safety assessments of lead candidate molecules, OREX-1019 and OREX-1038, selected from two series of compounds developed by Prof. Stephen Husbands, Ph.D. at the University of Bath in the United Kingdom and exclusively licensed to Orexigen in 2015. Orexigen researchers, in collaboration with contract research organizations and renowned opioid researchers, have demonstrated the therapeutic potential of OREX-1019 and OREX-1038 in preclinical efficacy models of pain and addiction as well as established key drug development characteristics.
Key data for OREX-1019 includes opioid receptor activation data that suggests a profile between standard of care buprenorphine and naltrexone-based treatments. Pre-treatment with OREX-1019 significantly suppressed opioid self-administration in models of addiction while itself being significantly less priming in addiction models than buprenorphine.
Key data for OREX-1038 includes an agonist/antagonist opioid receptor activation profile and potent analgesic activity in several models of pain when compared to traditional opioid standards and significantly reduced self-administration in studies of addiction. Further, doses of OREX-1038 significantly higher than required for the analgesic activity did not induce constipation or other side effects associated with standard of care opioids.
"The statistics for prescription opioid and heroin abuse and addiction in the U.S. underscore a real public health epidemic that requires new and less addictive pain medications as well as new tools for treating addiction," said
About Opioid Addiction
About Orexigen's Preclinical Early Development Programs
One compound family includes OREX-1019 which demonstrates a molecular profile and initial data supporting therapeutic use in the treatment and management of opioid addiction. Compounds in the second series including OREX-1038 are promising analgesics with the potential for significantly reduced abuse liability and physical dependence compared to current opioid analgesics.
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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," "should," "intends," "potential," "suggests," "assuming," "designed" and similar expressions are intended to identify forward-looking statements. These statements are based on our current beliefs and expectations. These forward-looking statements include statements regarding: the therapeutic potential for the OREX-1019 compounds in the treatment of opioid addiction; the potential for the OREX-1038 compounds to significantly reduce abuse liability and physical dependence compared to current opioid analgesics; the potential for either of the compound families to advance towards an Investigational New Drug Application; and the potential for and timing of the disclosure of additional information from the programs. 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 materially from those expressed or implied in this release due to the risk and uncertainties inherent in the Orexigen business, including, without limitation: the therapeutic value of the two compound families; the potential that the preclinical data for the compound families may not be predictive of future results in the related development programs; our ability to maintain sufficient capital to fund our operations for the foreseeable future; legal or regulatory proceedings against Orexigen, as well as potential reputational harm, as a result of misleading public claims about Orexigen; and other risks described in Orexigen's filings with the
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