Trevena (TRVN) Announces TRV027 Selected for Study in Global REMAP-CAP Trial in COVID-19 Patients

REMAP-CAP is led by experts in pandemic response and builds upon a worldwide clinical trial network evaluating treatments for COVID-19

Interim review of Imperial College London TRV027 study data supports transition to larger study

REMAP-CAP trial to study TRV027 in up to 300 patients

Trevena, Inc. (Nasdaq: TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system (CNS) disorders, today announced that TRV027, the Company’s novel AT1 receptor selective agonist, has been selected for inclusion in an international, multi-site, adaptive, Phase 2-Phase 3 trial in COVID-19 patients.

The trial is being conducted and funded as part of REMAP-CAP (Randomised, Embedded, Multi-factorial, Adaptive Platform Trial for Community-Acquired Pneumonia), a global network of clinicians, institutions, and research facilities with the objective of evaluating treatments with the potential to reduce mortality, ICU use, and morbidity in severely ill patients with COVID-19. REMAP-CAP is financially supported by an array of governments and research organizations worldwide.

“I am pleased with the addition of TRV027 to REMAP-CAP, a globally recognized research network that is leading the search for cutting-edge COVID-19 therapies,” said Carrie Bourdow, President and Chief Executive Officer of Trevena, Inc. “TRV027 holds immense potential as a treatment for the severe multi-organ damage and blood clotting caused by COVID-19, and I look forward to supporting the investigation of our novel asset in this innovative and expansive trial.”

The trial, known as the REMAP-CAP COVID-19 ACE2 RAS Modulation Domain, is designed specifically to evaluate treatments targeting the renin-angiotensin system (RAS) and determine whether modulation of the RAS is an effective strategy for preventing multiorgan failure and mortality in hospitalized COVID-19 patients. TRV027, which is based on Nobel Prize winning technology, combats disruption within the RAS 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.

“I am excited by the opportunity to study TRV027, a novel AT1 receptor selective agonist, as part of REMAP-CAP’s investigation of innovative treatments for COVID-19,” said Anthony Gordon, M.D., Professor of Anaesthesia and Critical Care at Imperial College London and a National Institute for Health Research (NIHR) Research Professor. “REMAP-CAP’s adaptive trial design allows us to gather a plethora of data on a treatment’s efficacy – particularly in certain patient populations or when administered in conjunction with other types of therapies — and I look forward to seeing what information we can glean from TRV027 as we evaluate its performance in COVID-19 patients.”

As previously announced, TRV027 is being investigated in a proof-of-concept study by Imperial College London. A recent review of the interim data by the study’s Data Monitoring and Safety Committee (DMSC) found that there were no safety concerns with TRV027, and the DMSC supported advancing TRV027 to a larger, more extensive study with clinical efficacy outcomes. Imperial College London anticipates winding down its study in the near future and is supporting the transition of TRV027 into the REMAP-CAP COVID-19 RAS domain study. David Owen, M.D., Ph.D., the chief investigator of Imperial College London’s TRV027 study, has joined the investigator team committee for the REMAP-CAP RAS domain study.

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