Trevena, Inc. announced preliminary topline data from two Phase 1 proof-of-concept studies of TRV045, a novel sphingosine-1-phosphate receptor modulator selective for the S1P receptor subtype 1. This data is expected in early fourth quarter 2023. In the previously reported Phase 1 study of TRV045, the only adverse event assessed by study investigators as probably or definitely related to drug was headache in four subjects across all three parts of the study (n=53, n=27, n=9). Subjects in both studies were enrolled outside of the United States, and the studies were not conducted under the Investigational New Drug Application for TRV045.

TRV045 was not associated with lymphopenia and produced no changes in blood pressure, heart rate, or respiratory function at or above pharmacologically active doses in nonclinical studies. TRV045 is an investigational product and is not yet approved by the FDA.