June 08, 2020, FibroGen, Inc. (NASDAQ: FGEN) today announced the initiation of an open-label, randomized, parallel-arm study investigating the efficacy and safety of pamrevlumab versus standard of care in patients with severe coronavirus 2019 (COVID-19) infection.
The trial is being conducted by Professor Luca Richeldi, M.D., Ph.D., Head of the Division of Pulmonary Medicine at Fondazione Policlinico Universitario A. Gemelli IRCCS, and Professor of Respiratory Medicine at Catholic University of the Sacred Heart in Rome, Italy.
BOREA is a Phase 2/3 investigator-initiated clinical trial investigating the efficacy and safety of pamrevlumab in approximately 68 patients hospitalized with COVID-19. The primary objective of this study is to assess the effect of pamrevlumab on blood oxygenation in patients with COVID-19 infection. Patients will be randomized to treatment with pamrevlumab or standard of care in a 1:1 ratio.
Based on the investigator’s decision, a subgroup of patients may continue treatment for up to 12 weeks.
“Recent data indicate the presence of interstitial pneumonia in the majority of hospitalized patients infected with COVID-19. The interstitial pneumonia is usually bilateral and leads to decreased blood oxygen levels, respiratory failure, intubation, and, ultimately, death in a significant proportion of patients who require mechanical ventilation,” said Elias Kouchakji, M.D., Senior Vice President, Clinical Development, Drug Safety, and Pharmacovigilance, FibroGen. “Connective tissue growth factor (CTGF) may promote vascular leakage and lead to pulmonary edema.
Administration of pamrevlumab, an anti-CTGF monoclonal antibody, may reverse this edema, and thus improve oxygenation in patients with COVID-19-induced pneumonia.”
Pamrevlumab is a first-in-class antibody developed by FibroGen to inhibit the activity of CTGF, a common factor in fibrotic and proliferative disorders characterized by persistent and excessive scarring that can lead to organ dysfunction and failure. This trial will assess pamrevlumab’s effect on patient time to and on ventilatory support, currently the most urgent need, and its potential to reduce mortality and fibrotic sequelae in the lung.
FibroGen today also announced the planned initiation of two additional randomized, double-blind, placebo-controlled Phase 2 studies investigating the efficacy and safety of pamrevlumab versus standard of care in patients with severe COVID-19 infection in the United States.
- The Investigational New Drug (IND) application for the first trial has been approved by the U.S. Food and Drug Administration (FDA), and it will assess the efficacy and safety of pamrevlumab in approximately 130 patients hospitalized with COVID-19 in the acute setting.
° This is a randomized, double-blind, placebo-controlled study, to assess the efficacy and safety of pamrevlumab in hospitalized patients with acute COVID-19 infection, in a 1:1 ratio.
° The primary efficacy assessment is the proportion of hospitalized COVID-19 patients who never receive mechanical ventilation and/or extracorporeal membrane oxygenation (ECMO) and remain alive at day 28.
- The second planned U.S. trial, under discussion with the FDA, is expected to assess the longer term efficacy and safety of pamrevlumab in patients who recovered or are recovering from COVID-19 infection with evidence of interstitial lung disease.
“Given our expertise in CTGF biology and its potential application in lung disease, we have a unique approach to the treatment of patients suffering from severe pulmonary involvement of COVID-19. The Italy and U.S. trials will determine if pamrevlumab treatment of hospitalized COVID-19 patients improves patient outcomes, both during the acute phase of infection and longer term with improved outcomes in interstitial lung disease,” said Enrique Conterno, Chief Executive Officer, FibroGen. “In these devastating times, we are grateful for the collaboration of health authorities, health care providers, and patients in enabling the conduct of these trials.”
