On August 7, 2018 FibroGen, Inc. (NASDAQ: FGEN), a biopharmaceutical company, reported financial results for the second quarter of 2018 and provided an update on the company’s recent developments (Press release, FibroGen, AUG 7, 2018, View Source;p=irol-newsArticle&ID=2362566 [SID1234528493]).
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"We are encouraged by the progress of our discussions with the FDA in advancing the development of pamrevlumab in IPF and locally advanced pancreatic cancer into pivotal Phase 3 clinical trials, including with the potential for accelerated approval in LAPC," said Thomas B. Neff, FibroGen’s Chief Executive Officer. "Meanwhile, we are on track with timelines for regulatory submission of roxadustat for the treatment of CKD anemia in multiple regions, as we have made significant progress toward approval in China, and our studies for U.S. approval are completing and will read out in the fourth quarter of this year."
Recent Developments and Highlights
Roxadustat for Anemia in Chronic Kidney Disease (CKD) in the U.S./EU
U.S. Phase 3 trial enrollment completed
Topline Phase 3 clinical data readout on target for the fourth quarter of 2018
Pooled MACE safety data anticipated in early 2019
New Drug Application (NDA) submission to the U.S. Food and Drug Administration (FDA) on target for the first half of 2019
In its most recent and final review, the data safety monitoring board recommended Phase 3 clinical studies continue under current protocols with no changes
Roxadustat for Anemia in CKD in China
NDA approval decision by the State Drug Administration (SDA) anticipated by year-end 2018
Roxadustat for Anemia Associated with MDS in China
Patient dosing underway in Phase 2/3 study
Roxadustat for Anemia in CKD in Japan
Astellas and FibroGen announced positive topline results from double-blind Phase 3 study in hemodialysis CKD patients in May 2018
Astellas plans to submit NDA for anemia associated with dialysis-dependent CKD in 2018
Astellas expects to announce topline data readout from the first of two ongoing non-dialysis-dependent CKD Phase 3 studies in the fourth quarter of 2018
Pamrevlumab for Idiopathic Pulmonary Fibrosis (IPF)
Positive Phase 2b efficacy and safety results (improvements in lung function (FVC), quantitative measure of fibrosis (HRCT) and quality of life (SGRQ)) reported in multiple poster presentations at the 2018 American Thoracic Society (ATS) Conference in May 2018
Met with the FDA on IPF Phase 3 design; Phase 3 study planned to begin in early 2019
Pamrevlumab for Pancreatic Cancer
Positive Phase 1/2 clinical results showing higher rates of eligibility for surgical resection and tumor resection rates in patients treated with roxadustat, presented at the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in June 2018
Agreement with the FDA on pivotal trial design with approximately 260 patients; trial planned to begin in early 2019
Corporate and Financial
Net loss for the second quarter was $23.4 million, or ($0.28) per share, compared to $31.9 million, or ($0.46) per share, primarily due to recognition of a milestone payment for an upcoming Japan NDA submission
At June 30, 2018, FibroGen had $733.7 million of cash, cash equivalents, investments, restricted time deposits, and receivables
The weighted average number of common shares used to calculate net loss per share was 83.8 million shares and 69.6 million shares for the second quarters of 2018 and 2017, respectively. Total shares outstanding as of June 30, 2018 were 84.2 million shares
Conference Call and Webcast Details
FibroGen will host a conference call and webcast today, Tuesday, August, 7, 2018, at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time) to discuss financial results and provide a business update. 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 2018 financial results conference call, and use passcode 47339190#. A replay of the webcast will be available shortly after the call for a period of two weeks. To access the replay, please dial 1 (888) 843-7419 (domestic) or 1 (630) 652-3042 (international), and use passcode 47339190#.
About Roxadustat
Roxadustat (FG-4592) is a first-in-class, orally administered small molecule currently in global Phase 3 clinical development as a potential therapy for anemia associated with chronic kidney disease (CKD). Roxadustat is a hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) that promotes erythropoiesis through increasing endogenous erythropoietin, improving iron regulation, and reducing hepcidin. Administration of roxadustat has been shown to induce coordinated erythropoiesis – increasing red blood cell count while maintaining plasma erythropoietin levels within or near normal physiologic range in multiple subpopulations of CKD patients, including in the presence of inflammation and without a need for supplemental intravenous iron.
Astellas and FibroGen are collaborating on the development and commercialization of roxadustat for the treatment of anemia in patients with CKD in territories including Japan, Europe, the Commonwealth of Independent States, the Middle East, and South Africa. AstraZeneca and FibroGen are collaborating on the development and commercialization of roxadustat for the treatment of anemia in patients with CKD in the U.S., China, and other markets.
Roxadustat is advancing through Phase 3 clinical trials worldwide, with multiple trials completed. The Phase 3 program is supported by extensive Phase 2 clinical data demonstrating correction and maintenance of hemoglobin levels in multiple subpopulations of CKD anemia patients. Globally, the Phase 3 program encompasses a total of 15 Phase 3 studies to support independent regulatory approvals of roxadustat in both non-dialysis-dependent and dialysis-dependent CKD patients in the U.S., Europe, Japan, and China. Roxadustat is currently in Phase 3 clinical development for the treatment of anemia associated with myelodysplastic syndromes (MDS) in the U.S. and in Phase 2/3 development for MDS in China.
About Pamrevlumab
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 advancing towards Phase 3 clinical development for the treatment of idiopathic pulmonary fibrosis (IPF) and pancreatic cancer and has been granted Orphan Drug Designation (ODD) in each of these indications, and is currently in a Phase 2 trial for Duchenne muscular dystrophy (DMD). Pamrevlumab has received Fast Track designation from the U.S. Food and Drug Administration for the treatment of patients with locally advanced unresectable pancreatic cancer. Across all trials, 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.