FibroGen, Inc. (NASDAQ: FGEN) has just announced the topline results from their Phase 3 ZEPHYRUS-1 trial evaluating the safety and efficacy of pamrevlumab on patients with idiopathic pulmonary fibrosis (IPF). Unfortunately, the primary endpoint of force vital capacity (FVC) at week 48 wasn’t met with the mean decline in FVC from baseline to week 48 being 260 ml in the pamrevlumab arm compared to 330 ml in the placebo arm.
Additionally, the secondary endpoint of time to disease progression did not meet the pre-specified criteria either. Despite the results not meeting the expected criteria, FibroGen, Inc. is still dedicated to providing the best treatment and care for their patients.
The safety analysis of pamrevlumab revealed it to be generally safe and well tolerated, with the majority of treatment emergent adverse events reported as mild to moderate. Although treatment-emergent serious adverse events were observed in 28.2% of patients in the pamrevlumab group and 34.3% of patients in the placebo group, FibroGen is disappointed with the results of the Phase 3 clinical trial, ZEPHYRUS-1, and thus the second Phase 3 trial, ZEPHYRUS-2, will be discontinued. Despite the negative outcome, FibroGen would like to thank the participants in the trial for their dedication and commitment, and intends to communicate the results at an upcoming medical forum.
FibroGen is set to report topline data from its Phase 3 studies with pamrevlumab in the next two years, including for the treatment of ambulatory DMD patients (LELANTOS-2) by 3Q 2023 and locally advanced and metastatic pancreatic cancer (LAPIS and Precision Promise) by 1H 2024.
And as CEO Enrique Conterno announced, its mission is to “advance our pipeline and continue commercialization of roxadustat in China and other countries where approved.” With the promise of milestone results from these pivotal Phase 3 trials, FibroGen is poised to shape the future of therapeutic treatment.
Anticipate top-line data from pivotal Phase 3 studies of pamrevlumab in ambulatory DMD patients and unresectable pancreatic cancer by 2023 and 2024 respectively. Additionally, the filing of two INDs, FG-3165 (anti-Gal9 antibody) and FG-3163 (anti-CCR8 antibody), in Q1 2024 and Q4 2023 respectively, as well as the initiation of a Phase 2 trial of FG-3246, a novel anti-CD46 ADC for mCRPC in 2H 2024, offer promising pathways for further advancement.
FibroGen is taking decisive action to unlock the potential of its research and extend its cash runway into 2026 via a comprehensive cost reduction effort in the United States.
Be part of something amazing. Join over 350 patients from around the world and participate in the ZEPHYRUS-1 clinical trial. This randomized, double-blind, placebo-controlled, multi-center Phase 3 trial promises to invigorate IPF treatment by testing pamrevlumab. Participate in this trial for 48 weeks, and you could help define the future of IPF care. Additionally, you may be eligible to participate in the followup trial, ZEPHYRUS-2. Sign up today and be part of something larger than yourself.
About Idiopathic Pulmonary Fibrosis (IPF)
Idiopathic pulmonary fibrosis is a devastating chronic lung disorder that leaves sufferers with progressive and irreversible decline in lung functioning. As the disease progresses, lung tissue in the affected areas becomes damaged, stiff, and scarred, blocking the exchange of oxygen into the bloodstream. This results in irrepairable loss of lung functioning, extreme discomfort, and unfortunately, high death rates.
Pamrevlumab, an investigational first-in-class antibody developed by FibroGen, is being studied for its potential to treat several conditions, including locally advanced unresectable pancreatic cancer (LAPC), Duchenne Muscular Dystrophy (DMD), and metastatic pancreatic cancer. This revolutionary drug has been granted fast track, rare pediatric disease and orphan drug designation by the U.S Food and Drug Administration.
Clinical studies conducted on this groundbreaking drug seem to indicate it has a safety and tolerability profile that could make it suitable for diagnosis in IPF, DMD, and LAPC. Don’t miss out on this exciting new drug that could revolutionize treatments in these areas!
FibroGen, Inc. is a pioneering biopharmaceutical company that is paving the way for first-in-class therapeutics to treat unmet needs. From its expertise in connective tissue growth factor (CTGF) biology and hypoxia-inducible factor (HIF), FibroGen has developed Pamrevlumab to fight locally advanced unresectable pancreatic cancer (LAPC), metastatic pancreatic cancer, and ambulatory Duchenne muscular dystrophy (DMD).
Roxadustat (爱瑞卓®，EVRENZOTM) is already approved for the treatment of anemia in CKD patients on dialysis and not on dialysis in China, Europe, Japan, and various other countries. It is also being studied for chemotherapy-induced anemia (CIA) in China. To further add to the success of its research and development portfolio, FibroGen has recently acquired exclusive license for FOR46 and product candidates in immuno-oncology.
FibroGen’s future plans and prospects towards the development and commercialization of product candidates are filled with exciting possibilities. Our success in research results, clinical trials, and the release of our financial reports provide us with an optimistic outlook for our progress. However, we must take caution, as there are various risks associated with our endeavors that could lead to a different outcome than anticipated.
Our Annual Report on Form 10-K for the fiscal year ended December 31, 2022 and our Quarterly Report on Form 10-Q for the quarter ended March 31, 2023 each filed with the Securities and Exchange Commission contain detailed descriptions of these risks. We remain committed and take pride in our progress, striving towards our objective of improving lives with our products.