On Jun. 2, 2020, Trevena announced it had entered into a collaboration with Imperial College London to evaluate the potential of TRV027, a novel AT₁ receptor selective agonist, to treat acute lung injury contributing to acute respiratory distress syndrome (ARDS) in COVID-19 patients. ARDS is a major complication leading to mortality associated with COVID-19. Imperial College London will be sponsoring and funding this study, with additional support through the British Heart Foundation Centre for Research Excellence Award.

In a COVID-19 infection, the SARS-coronavirus-2 binds to and removes the ACE2 protein in the lungs, causing elevated levels of angiotensin II. This drives overactivation of the AT₁ receptor, which results in downstream acute lung injury. This often develops into ARDS, which can ultimately lead to mortality. TRV027 potentially counteracts the disproportionate levels of angiotensin II, by competitively binding to and rebalancing AT₁ receptor activation. Additionally, its unique mechanism of action preferentially engages the signaling pathway to promote reparative effects on lung tissue.

TRV027 is an investigational new drug that has previously been studied in 691 individuals. It has demonstrated efficacy, potency, and selectivity at the AT₁ receptor in nonclinical studies and has a well-characterized pharmacokinetic profile. In previous clinical trials, there was a low dropout rate associated with TRV027, and no significant safety issues were reported. In April 2020, the Company filed a provisional patent application with the United States Patent and Trademark Office covering the use of TRV027 to treat ARDS in COVID-19 patients.

This will be a randomized, double-blind, placebo-controlled Phase 1b proof-of-concept study in approximately 60 hospitalized, non-ventilated patients aged 65 or older with a confirmed or suspected COVID-19 infection. The study will determine whether TRV027, a novel AT₁ receptor selective agonist, modulates pathways that contribute to COVID-19 pathology. The primary endpoint is a coagulation cascade biomarker, which serves as a surrogate for measuring the effect of TRV027 on adverse health outcomes associated with increased mortality in COVID-19 infections. Imperial College London will be sponsoring and funding this study, with additional support through the British Heart Foundation Centre for Research Excellence Award.

TRV027 is a novel AT₁ receptor selective agonist. It is an investigational new drug that was studied through a Phase 2b trial for acute heart failure. TRV027 is currently being investigated as a potential treatment for acute lung injury contributing to ARDS in COVID-19 patients. TRV027 may counteract overactivation of the AT₁ receptor caused by SARS-coronavirus-2, while simultaneously promoting reparative effects on lung tissue. The use of TRV027 in COVID-19 patients has been proposed by Nobel Laureate Robert J. Lefkowitz, M.D., and Howard A. Rockman, M.D., both Professors of Medicine at Duke University and scientific co-founders of the Company, along with two of their colleagues, Laura M. Wingler, Ph.D., Duke University and Aashish Manglik, M.D., Ph.D., University of California San Francisco.