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NIDA provides additional support for clinical studies in addiction program

October 18, 2010
by Press Release
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Seattle — Omeros Corporation announced that the National Institute on Drug Abuse (NIDA) has provided an additional grant to fund clinical studies for the company's addiction program. This grant, which is for a total of approximately $3.6 million to be paid over a four-year period in equal amounts, will fund direct and indirect costs of Phase 2 clinical studies to be conducted by researchers at the New York State Psychiatric Institute (NYSPI). In Omeros' Addiction program, the Company is developing proprietary compositions that include peroxisome proliferator-activated receptor gamma (PPARgamma) agonists for the prevention and treatment of addiction to substances of abuse, such as opioids, nicotine and alcohol, as well as other compulsive behaviors, including eating disorders. Data from earlier European pilot clinical studies and animal models of addiction have demonstrated a previously unknown link between PPARgamma and addiction disorders.

Earlier this year, Omeros announced that NIDA agreed to fund substantially all of the costs of a Phase 2 clinical study to be conducted by NYSPI researchers to evaluate a PPARgamma agonist for the treatment of addiction to prescription opioids. The NIDA support announced today will be used to fund additional Phase 2 clinical studies to evaluate the effect of a PPARgamma agonist in combination with other agents on the use of heroin and cigarettes. These clinical studies will also be conducted at the NYSPI and will be led by the recipients of this grant award, Dr. Sandra D. Comer and Dr. Adam Bisaga. Omeros will have the right to reference the data obtained from these studies for subsequent submissions to the FDA and will retain all other rights in connection with its Addiction program.

"This latest grant from NIDA underscores the potential of our Addiction program to yield an effective therapeutic for a wide range of addictive disorders," stated Gregory Demopulos, MD, chairman and chief executive officer of Omeros. "We appreciate the continued support of NIDA and NYSPI in advancing the clinical development of this program."

"Our team looks forward to initiating enrollment in this study as soon as possible," stated Dr. Comer. "The preclinical and pilot clinical data are promising, and this funding allows us to explore further the clinical effects of a PPARgamma agonist on opioid addiction while expanding potential indications to include smoking cessation."

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