FibroGen Announces First Patient Enrolled in Pamrevlumab Clinical Trial in Patients Hospitalized in U.S. with Acute COVID-19

Rhea-AI Summary

FibroGen announced the initiation of a Phase 2 study evaluating pamrevlumab in hospitalized COVID-19 patients. This double-blind, placebo-controlled trial will enroll approximately 130 patients in the U.S. The primary objective is to assess pamrevlumab's efficacy in improving blood oxygenation, measured by the survival rate of patients not requiring mechanical ventilation by Day 28. Pamrevlumab targets CTGF, aiming to reduce acute respiratory distress syndrome symptoms during COVID-19. A second trial assessing long-term efficacy is also planned.

Positive

• Initiation of a Phase 2 study for pamrevlumab in COVID-19 patients.
• Study to enroll around 130 patients, indicating significant research commitment.
• Potential to improve patient outcomes in severe COVID-19 cases by addressing respiratory failure.

Negative

• None.

SAN FRANCISCO, June 23, 2020 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ: FGEN) today announced the initiation of a randomized, double-blind, placebo-controlled Phase 2 Study investigating the efficacy and safety of pamrevlumab in hospitalized patients with acute coronavirus 2019 (COVID-19) infection. This multicenter trial is being conducted in the U.S. and will enroll approximately 130 patients 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, and patients will be randomized to treatment with pamrevlumab or standard of care in a 1:1 ratio. The primary efficacy assessment is the proportion of hospitalized COVID-19 patients who have not received mechanical ventilation and/or extracorporeal membrane oxygenation (ECMO) and remain alive at Day 28.

“The majority of patients with severe forms of COVID-19 have bilateral interstitial pneumonia, causing reduction in oxygenation and severe respiratory failure,” said Elias Kouchakji, M.D., Senior Vice President, Clinical Development, Drug Safety, and Pharmacovigilance, FibroGen. “The administration of pamrevlumab, a first-in-class anti-connective growth factor monoclonal antibody, could protect the lung from the immediate consequences of the infection presented as acute respiratory distress syndrome.”

A second planned U.S. trial is expected to assess the longer term efficacy and safety of pamrevlumab in patients who have recovered or are recovering from COVID-19 infection with evidence of interstitial lung disease.   

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.

“Given our expertise in CTGF biology and the potential application of this unique approach to the treatment of patients with acute COVID-19 infection, we are excited to begin enrolling this trial in the U.S.” said Enrique Conterno, Chief Executive Officer, FibroGen. “We are grateful for the collaboration of the FDA, investigators, and patients in enabling the conduct of this trial.”

About Pamrevlumab
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.

About FibroGen
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.

Forward-Looking Statements
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.

Contact:
FibroGen, Inc.

Media Inquiries:
Sara Iacovino
1.703.474.4452
sara.iacovino@gcihealth.com

Investors:
Michael Tung, M.D.
Corporate Strategy / Investor Relations
1.415.978.1434
mtung@fibrogen.com

FAQ

What is the purpose of the Phase 2 study for pamrevlumab?

The study aims to evaluate the efficacy and safety of pamrevlumab in hospitalized COVID-19 patients, focusing on its effect on blood oxygenation.

How many patients will be enrolled in the pamrevlumab study?

Approximately 130 patients will be enrolled in the study across multiple centers in the U.S.

What is the primary endpoint of the Phase 2 study for FGEN?

The primary endpoint is the proportion of patients who survive without requiring mechanical ventilation by Day 28.

Are there any future studies planned for pamrevlumab?

Yes, a second trial is planned to assess the long-term efficacy and safety of pamrevlumab in patients recovering from COVID-19 with interstitial lung disease.

What is pamrevlumab and its significance in COVID-19 treatment?

Pamrevlumab is a first-in-class antibody that targets connective tissue growth factor (CTGF) and may help protect lung function in severe COVID-19 cases.