SAN FRANCISCO, April 03, 2023 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ: FGEN) today announced the completion of patient enrollment for ZEPHYRUS-2, a Phase 3 clinical study of pamrevlumab in patients with idiopathic pulmonary fibrosis (IPF), a chronic, progressive, and fatal lung disease.
“We are pleased to announce the completion of enrollment for our second Phase 3 study of pamrevlumab in IPF,” said Mark Eisner, M.D, M.P.H, Chief Medical Officer, FibroGen. “The ZEPHYRUS program consists of two phase 3 clinical trials that will evaluate the ability of pamrevlumab to attenuate fibrosis and lung function decline in patients with idiopathic pulmonary fibrosis. IPF is a fatal progressive disease, and patients need new treatment options to improve their clinical outcomes.”
Three hundred seventy-two (372) patients have been enrolled into ZEPHYRUS-2, a randomized, double-blind, placebo-controlled, multi-center Phase 3 trial designed to evaluate the efficacy and safety of pamrevlumab in patients with IPF. The primary endpoint of the study is the change from baseline in forced vital capacity (FVC) at 48 weeks. Top-line data from ZEPHYRUS-2 is anticipated in mid-2024. For more information about ZEPHYRUS-2, please visit www.clinicaltrials.gov (NCT04419558).
The first study in our pamrevlumabIPF Phase 3 clinical development program is ZEPHYRUS-1 (N=356). Like ZEPHYRUS-2, ZEPHYRUS-1 is a randomized, double-blind, placebo-controlled, multi-center Phase 3 trial with a primary endpoint of change from baseline in forced vital capacity (FVC). Top-line data from ZEPHYRUS-1 is anticipated in mid-2023. For more information about ZEPHYRUS-1, please visit www.clinicaltrials.gov (NCT03955146).
Idiopathic pulmonary fibrosis is a chronic lung disease characterized by a progressive and irreversible decline in lung function in which lung tissue becomes damaged, stiff, and scarred. As tissue 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.
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.
In the US, there is a prevalence of approximately 120,000 patients with IPF, with approximately 30,000 patients diagnosed each year. We believe the number of patients will continue to grow due to heightened awareness and improved methods for detection and diagnosis.
This release contains forward-looking statements regarding FibroGen’s strategy, future plans and prospects, and the timing of potential events, including statements regarding the development and commercialization of the company’s product candidates, the potential safety and efficacy profile of its product candidates, and timelines for our clinical programs. These forward-looking statements include, but are not limited to, statements about FibroGen’s plans and objectives 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. FibroGen’s 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 its various programs, including the enrollment and results from ongoing and potential future clinical trials, and other matters that are described in FibroGen’s Annual Report on Form 10-K for the fiscal year ended December 31, 2022, as filed with the Securities and Exchange Commission (SEC) on February 27, 2023, 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 FibroGen undertakes no obligation to update any forward-looking statement in this press release, except as required by law.
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