On May 6, 2021, Trevena announced that TRV027, the Company’s novel AT1 receptor selective agonist, had been selected for a National Institutes of Health (NIH) ACTIV (Accelerating COVID-19 Therapeutic Interventions and Vaccines) trial in COVID-19 patients. The objective of ACTIV-4d RAAS was to evaluate treatments targeting the RAAS and to determine whether modulation of the RAAS is an effective strategy for preventing progression to critical illness, multiorgan failure, or mortality in hospitalized COVID-19 patients.

TRV027 combats disruption within the renin-angiotensin-aldosterone system (RAAS) by specifically binding to and rebalancing AT₁ receptor activation, 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. The trial, known as ACTIV-4d RAAS, is a component of the National Heart, Lung, and Blood Institute (NHLBI) of the NIH’s CONNECTS (Collaborating Network of Networks for Evaluating COVID-19 and Therapeutic Strategies) initiative. The objective of ACTIV-4d RAAS is to evaluate treatments targeting the RAAS and to determine whether modulation of the RAAS is an effective strategy for preventing progression to critical illness, multiorgan failure, or mortality in hospitalized COVID-19 patients.

This is a multi-site, randomized, placebo-controlled, clinical trial with multiple treatment arms, each enrolling approximately 300 COVID-19 patients ≥ 18 years old. Multiple trial arms will test investigational agents, including TRV027, that target the RAAS through distinct mechanisms of action. The trial is evaluating the impact of TRV027 on recovery, supplemental oxygen use, need for mechanical ventilation and mortality.