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-- Novel Human Antibody Targets CTGF, A Central Mediator in Fibrosis --
SAN FRANCISCO, Sept. 30, 2019 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ: FGEN) today announced publication in The Lancet Respiratory Medicine of positive results from the company’s PRAISE Phase 2 clinical study of the efficacy and safety of pamrevlumab, a fully human recombinant monoclonal antibody against connective tissue growth factor (CTGF), for treatment of idiopathic pulmonary fibrosis (IPF). The publication, entitled, “Pamrevlumab (FG-3019), an anti-connective tissue growth factor therapy for idiopathic pulmonary fibrosis: a randomized, double-blind, placebo-controlled trial,” is available online.1
“IPF is a difficult-to-treat condition with a poor prognosis for patients and a great need for innovation and new medicines. I am excited by the promise of a therapy that differs from current therapies in directly targeting the underlying fibrotic mechanism of this disease, as measured by quantitative assessment,” said Professor Luca Richeldi, M.D., Ph.D., lead author of the paper, and Head of the Division of Pulmonary Medicine at Agostino Gemelli University Hospital of the Catholic University of the Sacred Heart in Rome, Italy. “As seen in the positive data reported from the PRAISE Phase 2 clinical study, pamrevlumab truly has a unique mechanism that may offer clinicians and their patients a safe and beneficial approach to addressing the progression of IPF and improving quality of life. I am pleased to see a promising anti-fibrotic therapeutic as pamrevlumab advance into Phase 3 studies.”
In the Phase 2 randomized, placebo-controlled PRAISE study, the decline in percentage of predicted forced vital capacity (FVC) (the primary efficacy outcome) was significantly lower in the pamrevlumab group than in the placebo group. Specifically, the mean change from baseline to Week 48 in percentage of predicted FVC was -2.9% in the pamrevlumab group compared with -7.2% in the placebo group (between-group difference 4.3% [95% CI 0.4-8.3]; p=0.033), which corresponded to a relative reduction in percentage of predicted FVC decline of 60.3% in patients treated with pamrevlumab.
Further, the proportion of patients with disease progression (decline in percentage of predicted FVC ≥10%, or death) was lower in the pamrevlumab group than in the placebo group. The difference between treatment groups was significant at Week 48 (10.0% in the pamrevlumab group versus 31.4% in the placebo group; p=0.0130). The results of this trial indicate that pamrevlumab reduced progression of idiopathic pulmonary fibrosis over a period of one year.
Other findings included positive results on multiple efficacy outcomes, including lung function and, for the first time, quality of life and chest imaging with a quantitative high-resolution computed tomography (HRCT) score. Pamrevlumab was well tolerated in this study.
“Publication of the PRAISE data in The Lancet Respiratory Medicine highlights the potential impact of pamrevlumab as a treatment that not only slows decline in lung function, but targets the pathology of the underlying fibrosis,” said Elias Kouchakji, M.D., Senior Vice President, Clinical Development, Drug Safety, and Pharmacovigilance, FibroGen. “With strong Phase 2 results showing significant improvement in the primary efficacy endpoint of FVC change from baseline, and reduction in disease progression, we are committed to advancing this program, consistent with the vision of our late CEO, Tom Neff, whose goal in founding FibroGen was to treat fibrotic disease.”
Pamrevlumab is currently in Phase 3 clinical development for the treatment of IPF. The ZEPHYRUS study is a randomized, double-blind, placebo-controlled, multi-center trial designed to evaluate the efficacy and safety of pamrevlumab over a 52-week period. The primary endpoint of this global study is the change in FVC from baseline. Approximately 565 subjects will be enrolled. Subjects who complete the 52-week study may be eligible for rollover into a separate study offering open-label, extension treatment with pamrevlumab. For more information about the ZEPHYRUS study, please visit https://clinicaltrials.gov/ct2/show/NCT03955146.
In this completed, double-blind, placebo-controlled study (NCT01890265), eligible patients at 39 sites in 7 countries were randomized in a 1:1 ratio using interactive responsive technology (IRT) to pamrevlumab 30 mg/kg or placebo administered by intravenous infusion every 3 weeks over 48 weeks (for a total of 16 infusions). The primary efficacy endpoint was change from baseline in forced vital capacity (FVC) % predicted at Week 48. Lung function assessments (FVC) were conducted at baseline and at Weeks 12, 24, 36, and 48. Quantitative HRCT assessments were performed at baseline and at Weeks 24 and 48. Additional secondary endpoints of the study were disease progression, health-related quality of life, and safety.
About Idiopathic Pulmonary Fibrosis
Patients with IPF experience debilitating symptoms, including shortness of breath and difficulty performing routine functions, such as walking and talking. Other symptoms include chronic dry, hacking cough, fatigue, weakness, discomfort in the chest, loss of appetite, and weight loss. Over the last decade, refinements in diagnosis criteria and enhancements in high-resolution computed tomography imaging technology (HRCT) have enabled more reliable diagnosis of IPF without the need for a lung biopsy.
U.S. prevalence and incidence of IPF is estimated to be 135,000 cases (defined by ICD-9 code) and 21,000 new cases per year, respectively, based on Raghu et al. (Am J Respir Crit Care Med, 2006) and on data from the United Nations Population Division. We believe the number of patients will continue to grow due to heightened awareness and improved methods for detection and diagnosis.
Pamrevlumab is a first-in-class antibody developed by FibroGen to inhibit the activity of connective tissue growth factor (CTGF), a common factor in fibrotic and proliferative disorders characterized by persistent and excessive scarring that can lead to organ dysfunction and failure. Pamrevlumab is in Phase 3 clinical development for the treatment of idiopathic pulmonary fibrosis (IPF) and for the treatment of locally advanced unresectable pancreatic cancer (LAPC), and in Phase 2 clinical development for the treatment of Duchenne muscular dystrophy (DMD). The U.S. Food and Drug Administration has granted Orphan Drug Designation (ODD) to pamrevlumab for the treatment of patients with IPF, LAPC, and DMD. Pamrevlumab has also received Fast Track designation from the U.S. Food and Drug Administration for the treatment of patients with IPF and LAPC. Across all clinical studies, pamrevlumab has consistently demonstrated a good safety and tolerability profile to date. For information about pamrevlumab studies currently recruiting patients, please visit www.clinicaltrials.gov.
FibroGen, Inc., headquartered in San Francisco, California, with subsidiary offices in Beijing and Shanghai, People’s Republic of China, is a leading biopharmaceutical company discovering and developing 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, and clinical development to advance innovative medicines for the treatment of anemia, fibrotic disease, and cancer. Roxadustat, the company’s most advanced product candidate, is an oral small molecule inhibitor of HIF prolyl hydroxylase (HIF-PH) activity, completing worldwide Phase 3 clinical development for the treatment of anemia in chronic kidney disease (CKD), is approved by the National Medical Products Administration (NMPA) in China for CKD patients on dialysis and not on dialysis and by the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan for CKD patients on dialysis. Roxadustat is in Phase 3 clinical development in the U.S. and Europe and in Phase 2/3 development in China for anemia associated with myelodysplastic syndromes (MDS), and in a Phase 2 U.S. trial for treatment of chemotherapy-induced anemia. Pamrevlumab, an anti-CTGF human monoclonal antibody, is in Phase 3 clinical development for the treatment of idiopathic pulmonary fibrosis (IPF) and pancreatic cancer, and is currently in a Phase 2 trial for Duchenne muscular dystrophy (DMD). FibroGen is also developing a biosynthetic cornea in China. 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 of the company’s product candidates, the potential safety and efficacy profile of our product candidates, and our clinical, regulatory plans, 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, 2018 and our quarterly report on 10-Q for the fiscal quarter ended June 30, 2019 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.
Karen L. Bergman
Vice President, Investor Relations and Corporate Communications