Meets Primary Endpoint with Statistical Significance
Management to discuss results on today’s quarterly financial results conference
call
SAN FRANCISCO, Aug. 07, 2017 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ:FGEN), a science-based biopharmaceutical company,
announced today positive topline results from the company’s Phase 2 randomized, double-blind, placebo-controlled study and two
combination safety sub-studies of pamrevlumab in patients with idiopathic pulmonary fibrosis (IPF). Pamrevlumab is a proprietary,
first-in-class, anti-connective tissue growth factor (CTGF) antibody being evaluated in fibrotic disease and cancer.
“I am pleased to see positive Phase 2 results with pamrevlumab -- an antibody against CTGF, a new target in fibrosis -- which
has a good safety profile and the potential to provide alternative, much-needed new treatment options for IPF patients,” said 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.
In the double-blind, placebo-controlled portion of this study, one hundred-three (103) patients were randomized (1:1) to receive
either pamrevlumab or placebo for 48 weeks. Pamrevlumab met the primary efficacy endpoint of change of forced vital capacity
percent predicted (FVC % predicted), a measure of change in lung volume, from baseline to week 48 of the study:
• Statistical significance was demonstrated using a linear slope analysis in the intent to treat population:
- Average decline in FVC % predicted from baseline to week 48 was 2.85 in the pamrevlumab arm as compared to an average decline
of 7.17 in the placebo arm, an absolute difference of 4.33.
- Pamrevlumab-treated patients had an average decrease in FVC of 129 ml at week 48 compared to an average decrease of 308 ml in
patients receiving placebo.
• Consistent with previous clinical studies, pamrevlumab was well tolerated in IPF patients.
In the double-blind, active-controlled combination sub-studies, fifty-seven (57) patients were randomized to assess the safety
of combining pamrevlumab with approved IPF therapies. Thirty-six (36) patients on a stable dose of pirfenidone were randomized 2:1
to also receive pamrevlumab or placebo for 24 weeks. Twenty-one (21) patients on a stable dose of nintedanib were randomized 2:1 to
also receive pamrevlumab or placebo for 24 weeks. Pamrevlumab was well tolerated when administered in combination with either
pirfenidone or nintedanib.
“The positive results from this randomized placebo-controlled Phase 2 study build on our previous clinical data which
demonstrated the potential of pamrevlumab to slow the progression of IPF with a good safety and tolerability profile,” said Peony
Yu, M.D., FibroGen’s Chief Medical Officer. “We are conducting further analyses and look forward to presenting additional data from
this study in the months ahead. We believe these results support a Phase 3 program in patients suffering from this debilitating and
deadly disease.”
FibroGen plans to present these and additional results at the upcoming 2017 European Respiratory Society International Congress
in September. The company anticipates meeting with the U.S. Food and Drug Administration to address the clinical and
regulatory path forward for pamrevlumab in this indication.
Conference Call Details
FibroGen will host a conference call and webcast today, August 7, 2017, at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time), during
which management will discuss the company’s financial results and the topline results of the company’s randomized, double-blind,
placebo-controlled Phase 2 clinical study of pamrevlumab in IPF. A live audio webcast of the call may be accessed in the investor
section of the company’s website, www.fibrogen.com. To participate in the conference call by telephone, please dial 1 (888)
771-4371 (U.S. and Canada) or 1 (847) 585-4405 (international), reference the FibroGen Second Quarter 2017 conference call, and use
the confirmation number 45181364. A replay of the webcast will be available shortly after the call for a period of two weeks. To
access the replay, please dial (888) 843-7419 (domestic) or (630) 652-3042 (international), and use the confirmation number
45181364#.
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.
About Pamrevlumab
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.
Forward-Looking Statements
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, 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 no 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.
Contact FibroGen, Inc. Karen L. Bergman Vice President, Investor Relations and Corporate Communications 1.415.978.1433 kbergman@fibrogen.com