CHESTERBROOK, PA — Trevena, Inc. (Nasdaq: TRVN) announced it is advancing TRV045 into clinical development, following receipt of a notification from the U.S. Food and Drug Administration (FDA) that the study may proceed. TRV045 is the Company’s novel S1P1 receptor modulator being developed as a potential treatment for diabetic neuropathic pain (DNP). In addition, through a collaboration with the National Institutes of Health, the Company is also exploring TRV045 as a potential treatment for epilepsy.
“I am very pleased to have crossed this important milestone for the TRV045 development program and look forward to beginning our evaluation of this exciting molecule in the clinic,” said Carrie Bourdow, President and CEO of Trevena. “DNP is a painful condition that affects over 5 million people in the U.S., and currently available therapies are associated with both efficacy and tolerability concerns. TRV045 represents a potentially new approach to treating this burdensome condition, with an innovative mechanism of action at the S1P receptor.”
The Company will initiate a three-part Phase 1 single ascending dose (SAD), food effect, and multiple ascending dose (MAD) trial. The primary objective of the study is to evaluate the safety and tolerability of TRV045 in healthy adult subjects. The study will also assess the pharmacokinetics (PK) of TRV045 and determine whether TRV045 is associated with changes in lymphocyte counts, hemodynamic function, and QTcF interval.
In nonclinical studies, TRV045 was not associated with lymphopenia and produced no changes in blood pressure, heart rate, or respiratory function at or above pharmacologically active doses, unlike existing S1P receptor modulators, which are currently only approved by the FDA to treat multiple sclerosis and in one instance to treat moderately to severely active ulcerative colitis in adults. To date, there have been no head-to-head clinical studies of TRV045 compared to existing S1P receptor modulators.
Trevena reports that this will be a three-part randomized, double-blinded, placebo-controlled study in healthy volunteers. Part 1 of the study will investigate single ascending doses of TRV045 or placebo administered orally in up to 6 cohorts. Part 2 will investigate the effect of a high-fat meal on the safety, tolerability, and relative bioavailability of TRV045 in a single cohort. Part 3 will investigate multiple doses of TRV045 or placebo in up to 3 cohorts in order to obtain safety, tolerability, and PK (including dose proportionality) data under multiple-dosing conditions.
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