MILAN, Italy, Sept. 13, 2017 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ:FGEN), a science-based biopharmaceutical company, announced today positive results from the company’s Phase 2b randomized, double-blind, placebo-controlled study (Study 067) in patients with idiopathic pulmonary fibrosis (IPF) in an oral presentation by Luca Richeldi, M.D., Ph.D., Head of the Division of Pulmonary Medicine at Agostino Gemelli University Hospital of the Catholic University of the Sacred Heart in Rome, Italy, at the European Respiratory Society (ERS) International Congress 2017 in Milan. Pamrevlumab is a proprietary, first-in-class antibody targeting connective tissue growth factor (CTGF) that is being evaluated in fibrotic disease and cancer.
The clinical data presented underscore pamrevlumab’s potential therapeutic value for patients with IPF. In addition to the 103-patient, 48-week main study’s efficacy and safety results, Dr. Richeldi presented data from the two 24-week combination safety sub-studies.
“It is exciting to see positive results for this new therapeutic agent specifically targeting a key mechanism in the fibrotic disease process. In contrast to other agents, pamrevlumab brings a unique therapy to the treatment of IPF," said Dr. Richeldi.
Data presented at ERS include the following:
- Lower proportion of patients with FVC % predicted decline of >10% or deaths: At 48-weeks, the pamrevlumab-treated arm had a lower proportion of patients (10%) who experienced FVC % predicted decline ≥10% or death than did the placebo arm (31.4%).
- Pamrevlumab met the primary endpoint of FVC % predicted with statistical significance, as well as absolute FVC volume: in this study, the primary endpoint was met as the average decline in FVC % predicted of 2.85 in the pamrevlumab arm was statistically smaller than the average decline of 7.17 in the placebo arm, a difference of 4.33. These results are consistent with the decline in FVC % predicted by 2.29 observed in a subgroup of similar pamrevlumab-treated patients in an earlier Phase 2 open-label IPF study.
- FVC (mL) in the present study was similar to results from a prior open-label Phase 2 study: in the present study, pamrevlumab-treated patients had a statistically smaller decline in FVC volume with an average decrease in FVC (mL) of 129 mL at week 48, compared to an average decrease of 308 mL in patients receiving placebo. In the earlier completed study, the aforementioned subgroup (N=32) with baseline characteristics and pamrevlumab dose comparable to the current study, the decline in FVC (mL) over 48 weeks was 123 mL, consistent with the results from the pamrevlumab-treated arm in the current study.
- Pamrevlumab was well tolerated with no safety risks identified during the 48-week study: similarly, pamrevlumab was well tolerated when used in combination with the currently approved standard of care.
- Pharmacokinetic (PK)/pharmacodynamics (PD) analysis suggests opportunity for further optimization of treatment effect: the exposure – effect in the PK/PD analysis from the earlier Phase 2 study supports the potential for higher lung function (FVC) response in future IPF studies with either higher pamrevlumab doses or more frequent dosing than the 30 mg/kg every three weeks used in the present Phase 2b study.
“This clinical data advances our scientific understanding of anti-CTGF therapy and clinical findings for patients living with IPF,” said Peony Yu, M.D., Chief Medical Officer of FibroGen. “The IPF population has a critical need for a safer and more efficacious treatment with a distinctive mechanism.”
The second pamrevlumab presentation at the ERS presented data from a preclinical study in a radiation-induced lung fibrosis model in rodents comparing the effects of pamrevlumab monotherapy to that of pirfenidone or nintedanib and in combination with the currently approved therapies. In this study, pamrevlumab monotherapy exhibited lower lung density suggestive of less fibrosis with greater inhibition of progressive lung remodeling than monotherapy with either of the other two drugs, and pamrevlumab in combination with either pirfenidone or nintedanib was not statistically significantly better than pamrevlumab monotherapy.
"The superior activity of pamrevlumab in the late intervention of progressive fibrosis in a direct back-to-back comparison with two recently approved treatments for pulmonary fibrosis are intriguing and opens a new venue for development of anti-fibrotic therapy strategies,” said Amir Abdollahi, M.D., Ph.D., Head of the Division of Molecular and Translational Radiation Oncology, National Center for Tumor Diseases (NCT), Heidelberg Institute of Radiation Oncology (HIRO), Heidelberg University Medical School and German Cancer Research Center (DKFZ). “This data warrants further investigation of anti-CTGF therapy in IPF, and also in other fibrotic diseases such as radiation-induced fibrosis in cancer therapy.”
About Idiopathic Pulmonary Fibrosis (IPF)
IPF is a form of progressive pulmonary fibrosis, or abnormal scarring of the lungs. As the scarring progresses, transfer of oxygen into the bloodstream is increasingly impaired, leading to irreversible loss of lung function as well as high morbidity and mortality rates. Average life expectancy is estimated to be three to five years from diagnosis, with approximately two-thirds of patients dying within five years of diagnosis. Survival rates are comparable to those of some of the deadliest cancers.
IPF is designated as an orphan disease in the U.S., with prevalence and incidence of IPF estimated to be 135,000 cases (for IPF 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 proprietary therapeutic antibody developed by FibroGen to inhibit the activity of connective tissue growth factor (CTGF), a common factor in chronic fibrotic and proliferative disorders characterized by persistent and excessive scarring that can lead to organ dysfunction and failure. FibroGen is currently conducting clinical studies of pamrevlumab in idiopathic pulmonary fibrosis (IPF), pancreatic cancer, and Duchenne muscular dystrophy (DMD). In desmoplastic or fibrotic cancers, such as pancreatic cancer, CTGF promotes abnormal proliferation of stromal and tumor cells. For information about pamrevlumab studies currently recruiting patients, please visit www.clinicaltrials.gov.
About FibroGen, Inc.
FibroGen, Inc., headquartered in San Francisco, CA with subsidiary offices in Beijing and Shanghai, PRC, is a leading science-based biopharmaceutical company discovering and developing a pipeline of first-in-class therapeutics. The company applies its pioneering expertise in fibrosis and hypoxia-inducible factor (HIF) 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 activity in Phase 3 clinical development for the treatment of anemia in chronic kidney disease (CKD) and is entering Phase 3 development for anemia in lower risk myelodysplastic syndromes (MDS). Pamrevlumab, a fully-human monoclonal antibody that inhibits the activity of connective tissue growth factor (CTGF), is in Phase 2 clinical development for the treatment of idiopathic pulmonary fibrosis (IPF), pancreatic cancer, and 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 candidate pamrevlumab, the potential safety and efficacy profile of our product candidates, the potential dosing regimen, and our clinical plans. 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,” “should,” “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 for pamrevlumab, and other matters that are described in our Annual Report on Form 10-K for the fiscal year ended December 31, 2016, and our Quarterly Report on Form 10-Q for the quarter ended June 30, 2017, 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