Trevena, Inc. Announces Initiation of Olinvyk® Respiratory Physiology Study Including Elderly / Obese Subjects
July 07, 2021 at 07:00 am EDT
Share
Trevena, Inc. announced it has initiated a new study evaluating the physiologic impact of OLINVYK on respiratory function in elderly /obese subjects. This latest study is being led by Albert Dahan, M.D., Ph.D., Professor of Anesthesiology at the Leiden University Medical Center and a leading clinical researcher on the effects of opioid medications on respiratory physiology in humans. This study expands upon previously published work that the Company reported in collaboration with Dr. Dahan’s research team. That work used clinical utility function analysis methodology based on the original OLINVYK Phase 1 ventilatory response to hypercapnia (VRH) data. Clinical utility function analysis is a novel method used in various scientific areas of research that integrates multiple physiologic inputs into a single integrated output function, as a method of estimated risk and benefit. In this study, the integrated inputs of interest are analgesia (benefit) and respiratory depression (risk). This is a Phase 1 randomized, double-blind, four-period crossover trial enrolling subjects = 55 years old across a range of BMIs. The study aims to recruit ~50% of subjects who are = 65 years old and ~30% of subjects with a BMI > 30 kg/m2. All subjects will receive two doses of OLINVYK and two doses of IV morphine to obtain a range of plasma concentrations that span the clinically relevant range for each medication. Respiratory depression will be assessed using the VRH measure, which is widely recognized as a precise method to assess respiratory physiology in humans. Analgesia will be measured using the cold pressor test, which is a valid and sensitive index of the pharmacologic effects of opioid agonists. The study will evaluate the ventilatory and analgesic effects of both treatments through population PK /PD modeling and clinical utility function analysis. Enrollment is expected to begin in Third Quarter 2021, and the Company expects to report topline data by year-end 2021.
Trevena, Inc. is a biopharmaceutical company focused on the development and commercialization of medicines for patients with central nervous system (CNS) disorders. The Company has one approved product in the United States, OLINVYK (oliceridine) injection, indicated in adults for the management of acute pain severe enough to require an intravenous opioid analgesic and for whom alternative treatments are inadequate. The Companyâs pipeline includes three differentiated investigational drug candidates: TRV045 for diabetic neuropathic pain and epilepsy, TRV250 for the acute treatment of migraine and TRV734 for maintenance treatment of opioid use disorder. TRV045 is a novel, highly selective sphingosine-1-phosphate subtype 1 (S1P1) receptor modulator being developed as a potential treatment for acute and chronic neuropathic pain secondary to diabetic peripheral neuropathy. TRV734 is a small molecule G-protein biased ligand of the mu opioid receptor (MOR).