Additional Pamrevlumab Clinical Trials Planned in Patients Hospitalized in United States with Severe COVID-19
SAN FRANCISCO, June 08, 2020 (GLOBE NEWSWIRE) -- 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.”
Pamrevlumab is a first-in-class antibody developed by FibroGen that inhibits the activity of connective tissue growth factor (CTGF), a common factor in fibrotic and proliferative disorders. Pamrevlumab is in Phase 3 clinical development for the treatment of idiopathic pulmonary fibrosis (IPF) and locally advanced unresectable pancreatic cancer (LAPC), and in Phase 2 clinical development for the treatment of Duchenne muscular dystrophy (DMD) and coronavirus (COVID-19). For information about pamrevlumab studies currently recruiting patients, please visit www.clinicaltrials.gov.
FibroGen, Inc. is a biopharmaceutical company committed to discovering, developing and commercializing a pipeline of first-in-class therapeutics. The company applies its pioneering expertise in hypoxia-inducible factor (HIF) and connective tissue growth factor (CTGF) biology to advance innovative medicines to treat unmet needs. The Company is currently developing and commercializing roxadustat, an oral small molecule inhibitor of HIF prolyl hydroxylase activity, for anemia associated with chronic kidney disease (CKD). Roxadustat is also in clinical development for anemia associated with myelodysplastic syndromes (MDS) and for chemotherapy-induced anemia. Pamrevlumab, an anti-CTGF human monoclonal antibody, is in clinical development for the treatment of idiopathic pulmonary fibrosis (IPF), locally advanced unresectable pancreatic cancer, Duchenne muscular dystrophy (DMD), and coronavirus (COVID-19). For more information, please visit www.fibrogen.com.
This release contains forward-looking statements regarding our strategy, future plans and prospects, including statements regarding the development and commercialization of the company’s product candidates, the potential safety and efficacy profile of our product candidates, our clinical programs and regulatory events, and those of our partners. These forward-looking statements include, but are not limited to, statements about our plans, objectives, representations and contentions and are not historical facts and typically are identified by use of terms such as “may,” “will”, “should,” “on track,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “continue” and similar words, although some forward-looking statements are expressed differently. Our actual results may differ materially from those indicated in these forward-looking statements due to risks and uncertainties related to the continued progress and timing of our various programs, including the enrollment and results from ongoing and potential future clinical trials, and other matters that are described in our Annual Report on Form 10-K for the fiscal year ended December 31, 2019 and our Quarterly Report on Form 10-Q for quarter ended March 31, 2020 filed with the Securities and Exchange Commission (SEC), including the risk factors set forth therein. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release, and we undertake no obligation to update any forward-looking statement in this press release, except as required by law.
Michael Tung, M.D.
Corporate Strategy / Investor Relations
Source: FibroGen, Inc