Trevi Therapeutics announced that it had entered into exclusive license agreements with Rutgers, The State University of New Jersey and MentiNova, Inc. for intellectual property and data supporting the development of nalbuphine ER for levodopa-induced dyskinesia (LID) in patients with Parkinson’s disease.
MentiNova was co-founded by Dr. M. Maral Mouradian, a movement disorders specialist and Endowed Chair for Parkinson’s Research at Rutgers University. In preclinical research in a non-human primate model of Parkinson’s disease, treatment with nalbuphine resulted in a statistically significant reduction in dyskinesia, maintaining anti-LID activity with chronic administration, and was safe and well tolerated.
“We believe that several serious neurologically mediated conditions share a common pathophysiology that is mediated through opioid receptors in the central and peripheral nervous system. We have been developing nalbuphine ER for chronic pruritic conditions and believe it also has the potential to be effective in LID, as supported by MentiNova’s preclinical data. We look forward to advancing nalbuphine ER into a Phase 2 trial in Parkinson’s patients with LID in 2019,” said Jennifer L. Good, Trevi’s President & CEO.
Dr. Mouradian, President of MentiNova, said “I am pleased to see our preclinical work advance with Trevi as they move this program directly into patients with Parkinson’s disease. We have studied the mechanism of action of nalbuphine and believe it has the potential to provide a much-needed therapeutic option for patients suffering from levodopa-induced dyskinesia.”
Under the terms of the agreements, Trevi has an exclusive license to two issued U.S. patents, one issued Japanese patent, and additional pending applications in the U.S., Canada and Europe, as well as associated know-how. These patents relate to the use of nalbuphine in various movement disorders, including LID.