Trevena Inc (NASDAQ:TRVN) released preliminary topline data from two Phase 1 proof-of-concept studies of TRV045.
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.
The Target Engagement POC study in 25 subjects used the validated PainCart 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.
TRV045 demonstrated a statistically significant, dose-dependent reduction in mechanical allodynia following topical capsaicin application at 150mg and 300mg v. placebo.
Among the EEG-related endpoints measured in the study, resting state EEG obtained before and after administration of TRV045 demonstrated statistically significant increases in the power spectral density on day 4 in several middle to higher frequency bands, including alpha, beta, and gamma waves.
The changes in alpha waves are generally considered to be associated with conscious arousal and alertness, while beta waves are thought to be associated with GABA-mediated inhibitory cortical neurotransmission, and gamma waves are generally associated with cognitive processing, learning, and memory.
No serious adverse events were reported, and no drug-related discontinuations from either study.
Full safety and tolerability data for these studies are not yet available. This data is expected in early 4Q 2023.
Concurrently, Trevena received a $15 million tranche under its non-dilutive ex-US royalty-based financing, triggered by the first commercial sale of Olinvyk in China by Jiangsu Nhwa, the Company’s licensee in China.
Price Action: TRVN shares are up 23.4% at $1.08 during the premarket session on the last check Wednesday.
