CHESTERBROOK, PA —Trevena, Inc. (Nasdaq: TRVN) this week announced the initiation of a Phase 1 proof-of-concept study of TRV045, a novel sphingosine-1-phosphate receptor modulator selective for the S1P receptor subtype 1.
The study will use Transcranial Magnetic Stimulation (TMS) to evaluate how TRV045 affects the ability of brain cells to conduct electrical stimulation. The effects of TMS will be explored using both electromyography (EMG) and electroencephalography (EEG) to measure the potential effect of TRV045 on brain function.
“This is the second proof-of-concept study that we have initiated to explore TRV045 as a potential treatment of epilepsy and other CNS disorders,” said Carrie Bourdow, President and CEO of Trevena. “These studies are designed to build upon non-clinical data, which indicate the potential anti-inflammatory signaling and disease modifying effect of TRV045. We look forward to reporting topline data from both of our Phase 1 proof-of-concept studies later this year to help inform our future development path for TRV045.”
The study is a randomized, double-blind, placebo-controlled, two-way cross-over, multiple dose study designed to evaluate the pharmacodynamic effects of TRV045 on cortical excitability in healthy male adults, using both EMG and EEG to measure brain function. Twenty-four healthy male volunteers will be enrolled and each subject will receive one of two treatment sequences in random order: TRV045 250 mg followed by placebo; or placebo followed by TRV045 250 mg, each treatment sequence given once daily for four consecutive days. Both EMG and EEG outcomes in response to TMS will be explored after the first and last doses in each treatment sequence. Doses for this study were selected based on the PK exposure determined in the recently completed Phase 1 single and multiple dose study, and are designed to reach the expected target efficacy exposure range. Subjects will be enrolled at a study site outside of the United States and the study is not being conducted under the Investigational New Drug Application (IND) for TRV045. The study is expected to complete enrollment by mid-2023.
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