Trevena Announces First Patient Enrolled in NIH-Funded ACTIV-4 Host Tissue Trial of TRV027 for COVID-19


CHESTERBROOK, PA — Trevena, Inc. (Nasdaq: TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system (CNS) disorders, announced that the first COVID-19 patient has been enrolled in the NIH-funded ACTIV-4 Host Tissue (Accelerating COVID-19 Therapeutic Interventions and Vaccines) trial.

“There is no one solution to end COVID-19, and we are honored to play a role in the global effort to overcome this pandemic and mitigate its long-term impact on our communities,” said Carrie Bourdow, President and CEO of Trevena. “I am excited that patients are now being enrolled in this study and that TRV027 is the one of the first active treatment arms available for patient randomization.”

The trial, known as ACTIV-4 Host Tissue, is testing four investigational agents that combat dysregulation of the renin-angiotensin-aldosterone system (RAAS) and the immune system caused by a COVID-19 infection. TRV027 is a novel AT1 receptor selective agonist that specifically binds to and rebalances AT1 receptor activation within the RAAS, blocking the damaging pathway that leads to acute lung damage and abnormal blood clotting, while activating the cellular pathway that selectively targets reparative actions that improve lung function and promote anti-inflammatory effects.

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The trial is enrolling approximately 1,600 patients at over 50 sites in the U.S. TRV027 is part of the initial trial launch, and additional study arms will be added to the trial over time. The study is evaluating the impact of each intervention on recovery, supplemental oxygen use, need for mechanical ventilation, organ failure, and mortality.

“As the COVID-19 pandemic continues to evolve, the development of interventions that can combat the vascular, fibrotic, and inflammatory damage done by the coronavirus remains a top priority,” said Sean Collins, M.D., M.Sci., Principal Investigator of the ACTIV-4 Host Tissue trial, Co-Director of the Vanderbilt Coordinating Center and Professor of Emergency Medicine, Vanderbilt University Medical Center. “I am very pleased that we have enrolled our first patient in the ACTIV-4 Host Tissue trial, and I look forward to investigating the potential of TRV027 to modulate the RAAS and improve outcomes for patients hospitalized with COVID-19.”

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