Omeros Corporation announced that the National Institute on Drug Abuse (NIDA) is providing support for the company's addiction programme. NIDA will fund substantially all of the costs of a phase-2 clinical study to be conducted by New York State Psychiatric Institute researchers. In its Addiction programme, Omeros is developing proprietary compositions that include peroxisome proliferator-activated receptor gamma (PPAR-gamma) agonists for the prevention and treatment of addiction to substances of abuse, such as opioids, nicotine and alcohol, as well as other compulsive behaviours, including eating disorders. The company's data from earlier European pilot clinical studies and animal models of addiction have demonstrated a previously unknown link between PPAR-gamma and addiction disorders.
Under the agreement, the New York State Psychiatric Institute researchers, led by Dr Sandra D Comer, will conduct a phase-2 clinical study to evaluate a PPAR-gamma agonist in the treatment of addiction to opioids, expected to begin enrollment in the first half of this year. The study will be managed through the Research Foundation for Mental Hygiene (RFMH). The responsibilities of RFMH also include the filing of the related investigational new drug application (IND) with the Food and Drug Administration (FDA). Funding of substantially all of the costs of this study, including the regulatory costs, will be provided to RFMH through a grant from NIDA. Omeros will have the right to reference the data obtained from this study for subsequent submissions to the US FDA and will retain all other rights in connection with its Addiction programme.
"NIDA's support for this study marks an important step forward for our programme and validates its potential to prevent addiction and to treat patients suffering from substance abuse," stated Gregory Demopulos, chairman and CEO of Omeros. "We recognize that the investigators and NIDA moved quickly and we appreciate their financial and operational support."
"Our team looks forward to getting patients enrolled in this study as soon as possible," stated Dr Comer. "Addiction to opioids and other substances is a major public health problem, and the data from Omeros' preclinical and pilot clinical studies show that PPAR-gamma agonist therapy holds significant promise as an effective treatment."
Omeros Corporation is a clinical-stage biopharmaceutical company committed to discovering, developing and commercializing products focused on inflammation and disorders of the central nervous system.
Founded in 1896, the New York State Psychiatric Institute (PI) contributes importantly to knowledge about the understanding and treatment of psychiatric disorders.