CHESTERBROOK, PA — Trevena, Inc. (Nasdaq: TRVN) this week announced the enrollment of the first subject in a Phase 1 proof-of-concept study of TRV045, a novel sphingosine-1-phosphate receptor modulator selective for the S1P receptor subtype 1.
The Phase 1 clinical study is a randomized, double-blind, placebo-controlled, four-way cross-over study designed to test the mechanism of action and measure evidence of target engagement for TRV045. The study will use a validated set of analgesic tests to evaluate potential central and peripheral nervous system effects and to provide insight into the potential anti-inflammatory actions of TRV045. Twenty-four healthy volunteers will be enrolled and each subject will receive three different single doses of TRV045 (50mg, 150mg and 300mg) and placebo on four separate visits across the study duration. Doses for this study were selected based on the PK exposure determined in the recently completed Phase 1 single and multiple dose ranging study, and bracket the expected targeted efficacy exposure range. Subjects will be enrolled at sites outside of the United States and the study is not being conducted under the Investigational New Drug Application (IND) for TRV045.
The first subject in the trial was dosed in December 2022 and the study is expected to complete enrollment by mid-2023.
“We believe TRV045 represents an innovative, non-opioid based approach to the treatment of pain, and has also shown promising anti-inflammatory data in nonclinical models, suggesting a potential disease-modifying role in other CNS disorders,” said Carrie Bourdow, President and CEO of Trevena. “We look forward to reporting topline data from this target engagement study, which will help inform our future development path for TRV045.”
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