Omeros Announces Positive Data from Phase 2 Clinical Trial Evaluating PPAR-gamma Agonist in Cocaine Abuse
SEATTLE--(BUSINESS WIRE)--Omeros Corporation (NASDAQ: OMER) today announced positive results from a Phase 2 clinical trial evaluating the effects of a peroxisome proliferator-activated receptor (PPAR)-gamma agonist in patients with cocaine use disorder (CUD). The trial, designed and conducted by Joy M. Schmitz, Ph.D. and her colleagues at the Center for Neurobehavioral Research on Addiction, University of Texas Health Science Center – Houston, demonstrates that the PPAR-gamma agonist reduces craving and improves the integrity of brain white matter in patients with CUD. There currently are no approved medications to treat cocaine addiction. Omeros’ issued and pending patents in its OMS405 program cover the use of any PPAR-gamma agonist, alone or in combination with other addiction therapies, to treat all forms of addiction, including cocaine, nicotine, opioids, alcohol and other substances of abuse as well as addictive or compulsive behaviors.
“In drug abusers, cognitive decline associated with loss of neuronal function is a major negative prognostic factor”
In this double-blind, placebo-controlled Phase 2 clinical trial, 30 treatment-seeking CUD patients were randomized to receive either a PPAR-gamma agonist (n=15) or placebo (n=15) daily for 12 weeks. Measures of impulsivity, decision-making and cocaine craving were recorded at multiple time points. A subgroup of 19 patients (10 placebo patients and 9 PPAR-gamma-treated patients) underwent brain scans using diffusion tensor imaging (DTI) to measure white matter integrity before and after the course of treatment.
The data reveal a statistically significant time-dependent reduction in cocaine craving in PPAR-gamma-agonist-treated patients compared to placebo controls. Treated patients also showed improvement in white matter integrity in four target DTI regions of interest, specifically in the corpus callosum and in two associated thalamic tracts. During treatment, side effects reported were minimal and similar between the PPAR-gamma agonist and placebo groups. These clinical findings are consistent with results of earlier mechanistic and target-based preclinical studies showing that PPAR-gamma agonists protect against neuronal damage and block...