Omeros Elucidates Mechanism of its PDE7 Inhibitors in Addiction -- Clinical Entry Planned for Second Half of 2013 --
SEATTLE, March 19, 2013 /PRNewswire/ -- Omeros Corporation (NASDAQ: OMER) today announced that it has elucidated the mechanism of action of its phosphodiesterase 7 (PDE7) inhibitors in the neural network shown to be responsible for addiction in humans. Omeros believes that it is the first to discover the link between PDE7 and any addiction or compulsive disorder, and the Company is establishing a broad intellectual property position around this discovery. Omeros expects to submit an Investigational New Drug application or the European equivalent for its lead PDE7 inhibitor (OMS527) to permit the initiation of human clinical trials later this year.
Most, if not all, addictions and compulsions are directly tied to increased release of dopamine in the brain. Through an extensive battery of behavioral, electrophysiological and neurotransmitter studies in animals, Omeros identified the mechanism by which its proprietary PDE7 inhibitors reduce the heightened dopamine release caused by drugs of abuse. These studies generated consistent data demonstrating that Omeros' PDE7 inhibitors are effective in nicotine, cocaine, opioid and alcohol addiction as well as in binge eating and uncovered the activities of these compounds at specific sites within the neural network that controls addiction. These same neural pathways have been shown to be responsible for addictions and compulsive behaviors in humans.
"The mechanism by which our PDE7 inhibitors work in addiction cuts across multiple drugs of abuse," stated Gregory A. Demopulos, M.D., chairman and chief executive officer of Omeros. "With almost 1.5 billion nicotine addicts, 140 million alcoholics, 15 million cocaine addicts and 6 million opioid addicts worldwide, the addiction problem – and the pharmaceutical industry's interest in treating that problem – is growing. We look forward to evaluating OMS527 in humans, and we are advancing through toxicology studies in preparation for clinical trials later this year."
About Omeros' PDE7 Programs
Omeros' phosphodiesterase 7 (PDE7) program is based on its discoveries of previously unknown links between PDE7 and any addiction or compulsive disorder and between PDE7 and any movement disorders, such as Parkinson's disease. PDE7 appears to modulate the dopaminergic system, which plays a significant role in regulating both addiction and movement. Omeros believes that PDE7 inhibitors could be effective therapeutics for the treatment of addiction and compulsive disorders as well as movement disorders. Data generated in preclinical studies support both of these potential indications. Omeros also believes that it controls the worldwide rights to any PDE7 inhibitor for the treatment of any movement disorder, including Parkinson's disease, restless leg syndrome and Huntington's disease. Omeros has licensed its PDE7 inhibitors from Daiichi Sankyo Co., Ltd. for worldwide exclusivity in the fields of movement disorders, addictions and compulsive disorders.
Addiction is a significant medical problem with major socioeconomic impact. In the United States alone, the total socioeconomic cost of addiction is estimated at $484 billion per year, which is more than 60% greater than that for cancer and diabetes combined. Sales of current addiction medications exceed $4.4 billion worldwide, though they are either largely ineffective or have significant side-effects.
About Omeros Corporation
Omeros is a clinical-stage biopharmaceutical company committed to discovering, developing and commercializing products targeting inflammation, coagulopathies and disorders of the central nervous system. The Company's most clinically advanced product candidates, OMS302 for lens replacement surgery and OMS103HP for arthroscopy, are derived from its proprietary PharmacoSurgery™ platform designed to improve clinical outcomes of patients undergoing a wide range of surgical and medical procedures. Omeros has five clinical development programs. Omeros may also have the near-term capability, through its GPCR program, to add a large number of new drug targets and their corresponding compounds to the market. Behind its clinical candidates and GPCR platform, Omeros is building a diverse pipeline of protein and small-molecule preclinical programs targeting inflammation, coagulopathies and central nervous system disorders.
This press release contains forward-looking statements as defined within the Private Securities Litigation Reform Act of 1995, which are subject to the "safe harbor" created by those sections. These statements include, but are not limited to, Omeros' expectations regarding that it will begin clinical trials evaluating OMS527 this year, the potential indications that OMS527 could treat, and that Omeros may have capability, through its GPCR program, to add a large number of new drug targets and their corresponding compounds to the market. Forward-looking statements are based on management's beliefs and assumptions and on information available to management only as of the date of this press release. Omeros' actual results could differ materially from those anticipated in these forward-looking statements for many reasons, including, without limitation, the risks, uncertainties and other factors described under the heading "Risk Factors" in the Company's Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 19, 2013. Given these risks, uncertainties and other factors, you should not place undue reliance on these forward-looking statements, and the Company assumes no obligation to update these forward-looking statements publicly, even if new information becomes available in the future.
SOURCE Omeros Corporation