Clinical Pharmacology website
/PRNewswire/ – Trevena, Inc. (Trevena), a clinical stage pharmaceutical company and the leader in the discovery of G-protein coupled receptor (GPCR) biased ligands, today announced the electronic publication of Trevena’s manuscript, “First Clinical Experience with TRV027: Pharmacokinetics and Pharmacodynamics in Healthy Volunteers.” The manuscript can be viewed online at the Journal of Clinical Pharmacology’s website.
TRV027 is an experimental intravenous drug now in mid-stage clinical trials for the treatment of acute heart failure (AHF). The printed manuscript will appear in a future print issue of the journal. David G. Soergel, M.D., Trevena’s Senior Vice President of Clinical Development, Jonathan D. Violin, PhD, Director of Biology and Co-Founder of Trevena, and Michael W. Lark, PhD, Trevena’s Chief Scientific Officer and Senior Vice President of Research at Trevena, were among the publication’s authors.
The manuscript summarizes results from the first-in-human clinical study in which the compound was administered to healthy human subjects. In this study, the tolerability, pharmacokinetics and pharmacodynamics of multiple doses of TRV027 were explored. TRV027 was safe and well-tolerated, with a usefully short half-life and dose-proportional increases in systemic exposure. The compound showed a decrease in mean arterial pressure in subjects that had an elevation in their renin angiotensin aldosterone system, a common characteristic in AHF patients. TRV027′s activity, observed in the study, is consistent with its mechanism of action and previously published preclinical findings.
“In this phase 1 study, we successfully translated the unique activity profile of TRV027 from preclinical species into humans. These data supported our decision to progress TRV027 into Phase 2 studies in heart failure patients, ” commented Dr. Soergel.
About TRV027 and AHF
TRV027 is a novel beta-arrestin biased ligand of the angiotensin II type 1 receptor (AT1R) that combines the proven benefits of angiotensin blockade with new beta-arrestin-mediated biology to preserve cardiac and renal function. TRV027 is being developed by Trevena under a recently announced collaborative licensing option agreement with Forest Laboratories Inc. For more details, please find a copy of the press release on the Trevena website, under the “News” tab.
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