Trevena reports favorable TRV045 safety, tolerability data

Trevena reported topline safety and tolerability data for the two Phase 1 proof-of-concept studies of TRV045, a novel sphingosine-1 phosphate receptor modulator selective for the S1P receptor subtype 1. TRV045 POC Studies: The Target Engagement POC study was a randomized, double-blind, placebo-controlled, single dose four-way cross-over study. Each subject received three different single doses of TRV045 and placebo on four separate visits across the study duration. 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 Safety and Tolerability Data: There were no drug-related adverse events reported in either POC study, and no serious adverse events were reported in either POC study. Of the adverse events, 98% were reported as mild in the Target Engagement POC study, and 99% were reported as mild in the TMS POC study. The most common adverse events reported were headaches, somnolence, dizziness and fatigue. In screening and follow-up physical exams there were no clinically significant observations. Laboratory results also showed no clinically significant reduction in total lymphocyte count, no clinically significant changes in heart rate or blood pressure, and no clinically significant changes in ECG interval measures. As previously announced, TRV045 demonstrated a statistically significant, dose-dependent analgesic effect in capsaicin-induced model of neuropathic pain in the Target Engagement POC study. In the TMS POC study, TRV045 provided statistically significant evidence of CNS activity on day 4 as measured by EEG power spectral analysis.