CHESTERBROOK, PA — Trevena, Inc. (Nasdaq: TRVN) this week reported topline safety and tolerability data for the two Phase 1 proof-of-concept (POC) 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 (n=25 subjects). Each subject received three different single doses of TRV045 (50mg, 150mg and 300mg) and placebo on four separate visits across the study duration.
The TMS POC study was a randomized, double-blind, placebo-controlled, multiple dose, two-way cross-over study (n=25 subjects). Each subject received one of two treatment sequences in random order: TRV045 at a dose of 250mg, followed by placebo; or placebo followed by 250mg of TRV045, each treatment sequence given once daily for four consecutive days.
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% (102 of 104) were reported as mild in the Target Engagement POC study, and 99% (79 of 80) 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 (including ophthalmologic 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 (including no prolongation of PR or QTcF intervals).
This new safety and tolerability data in 50 subjects is generally consistent with, and further builds upon, the 89-subject data from the first-in-human study of TRV045 reported in November 2022. The data supports the Company’s belief that TRV045 has the potential to effectively target indications, such as neuropathic pain and epilepsy, without adverse events such as lymphopenia, bradycardia, pulmonary adverse events and ophthalmologic adverse events, which have been reported with other S1P receptor modulators.
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. Data from both studies demonstrated CNS penetration and target engagement, as well as plasma exposures in the anticipated active dose range, supporting the therapeutic potential of TRV045.
“We are pleased to report additional safety and tolerability data which is consistent with what we have observed in prior datasets,” said Carrie Bourdow, President and CEO of Trevena. “The two proof-of-concept studies builds upon our confidence to advance development of TRV045. Discussions with potential strategic partners are ongoing, and we look forward to advancing TRV045, on our own or with a partner, for potential treatment of neuropathic pain and other CNS disorders.”
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