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February 5, 2014
07:04 EDTTRVNTrevena initiates TRV734 clinical development
Trevena announced the initiation of its first Phase 1 trial for TRV734. TRV734 is being developed to optimize analgesia while minimizing on-target gastrointestinal and respiratory effects through its novel biased ligand mechanism at the mu-opioid receptor. TRV734 takes advantage of the same receptor specificity mechanism as does Trevena’s Phase 2 clinical candidate, TRV130. The main objective of this first-in-human trial is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single ascending doses of TRV734 in healthy subjects. The potentially efficacious dose range of TRV734 will also be evaluated using pupilometry, a validated biomarker for mu-opioid receptor engagement.
News For TRVN From The Last 14 Days
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October 21, 2014
06:27 EDTTRVNTrevena management to meet with Needham
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October 14, 2014
10:54 EDTTRVNTrevena management to meet with JMP Securities
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October 8, 2014
07:02 EDTTRVNTrevena announces early enrollment completion of TRV130 Phase 2a/b study
Trevena announced that it has closed enrollment of its Phase 2a/b study of intravenous TRV130 in postoperative bunionectomy pain after enrolling a pilot phase and eight of ten planned study cohorts in a second phase. Enrollment closed following a pre-specified interim analysis indicating that the trial had met its key objectives. As a result of the early completion of enrollment, Trevena now expects to report top-line results from the study this quarter, including efficacy, tolerability, and safety measures of TRV130 and morphine. This study was designed to enable Phase 3 development by providing information on dose- and interval-ranging and further elaborating the differentiation of TRV130 versus morphine. In this multicenter, randomized, double-blind, placebo- and active-controlled, multiple dose, adaptive study, the effects of TRV130 were assessed in patients following first metatarsal bunionectomy surgery. Following a pilot phase of the study, pre-specified interim analyses were performed after each cohort of 25 patients to determine dosing adaptations for successive cohorts. Patients were enrolled and randomized after surgery to receive TRV130, morphine or placebo to manage their pain postoperatively. Pain intensity and pain relief were measured using validated rating scales at multiple time points up to 48 hours during the study period. Efficacy, safety, and tolerability were measured in comparison to both placebo and a standard dose of morphine.

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