FibroGen Announces Completion of Patient Enrollment in LELANTOS-2, a Phase 3 Clinical Study of Pamrevlumab in Duchenne Muscular Dystrophy
FibroGen (FGEN) has completed the enrollment of 73 ambulatory Duchenne muscular dystrophy (DMD) patients in its Phase 3 LELANTOS-2 clinical trial, evaluating pamrevlumab. This study aims to assess the efficacy and safety of pamrevlumab in combination with corticosteroids, focusing on ambulatory function over 52 weeks. Top-line data is expected in the second half of 2023. Pamrevlumab has received Orphan Drug and Fast Track designations from the FDA for DMD treatment. The drug is also in trials for idiopathic pulmonary fibrosis and pancreatic cancer.
- Completed enrollment of 73 DMD patients, indicating progress in clinical study.
- Top-line data from LELANTOS-2 expected in 2H:2023, providing potential insights into efficacy.
- Pamrevlumab has received Orphan Drug Designation and Fast Track status from the FDA, enhancing its development profile.
- None.
- 73 Ambulatory DMD Patients Enrolled -
- Topline Data Anticipated 2H:2023 -
SAN FRANCISCO, June 08, 2022 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ: FGEN) today announced completion of patient enrollment for LELANTOS-2, a Phase 3 clinical study of pamrevlumab in patients with ambulatory Duchenne muscular dystrophy (DMD).
“We are very pleased to complete enrollment of our second Phase 3 study of pamrevlumab in patients with DMD,” said Mark Eisner, M.D, M.P.H, Chief Medical Officer, FibroGen. “Pediatric patients living with DMD have limited treatment options, and LELANTOS-2 will evaluate pamrevlumab as a potential new treatment. On behalf of the entire study team, we would like to extend our gratitude to the patients, caregivers, investigators and study staff for commitment to this study.”
A total of seventy-three (73) DMD patients aged 6 to 12 years old have been enrolled in LELANTOS-2, a global Phase 3, randomized, double-blind, trial of pamrevlumab or placebo in combination with systemic corticosteroids to evaluate the efficacy and safety of pamrevlumab in patients with ambulatory DMD. The primary endpoint of the study is ambulatory function assessment, measured by the change in North Star Ambulatory Assessment (NSAA) from baseline to Week 52. Top-line data from LELANTOS-2 study is anticipated in 2H:2023. For more information about LELANTOS-2 please visit www.clinicaltrials.gov (NCT04632940).
The Phase 3 clinical development program for pamrevlumab for DMD includes two studies, LELANTOS-1 and LELANTOS-2. These global Phase 3 trials are randomized and double-blinded designed to evaluate the efficacy and safety of pamrevlumab in combination with systemic corticosteroids in patients with either ambulatory or non-ambulatory DMD. Top-line data from LELANTOS-1 study is anticipated in 1H:2023. For more information about LELANTOS-1, which is fully enrolled, please visit www.clinicaltrials.gov (NCT04371666).
About Pamrevlumab
Pamrevlumab is a potential first-in-class antibody being 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 in Phase 3 clinical development for the treatment of idiopathic pulmonary fibrosis (IPF), locally advanced unresectable pancreatic cancer (LAPC), and Duchenne muscular dystrophy (DMD), and in Phase 2/3 for the treatment of metastatic pancreatic cancer. The U.S. Food and Drug Administration has granted Orphan Drug Designation (ODD), and Fast Track designation to pamrevlumab for the treatment of patients with IPF, LAPC, and DMD. The U.S. Food and Drug Administration has also granted Rare Pediatric Disease Designation to pamrevlumab for the treatment of patients with DMD. Pamrevlumab has demonstrated a safety and tolerability profile that has supported ongoing clinical investigation in IPF, LAPC, and DMD. Pamrevlumab is an investigational drug and not approved for marketing by any regulatory authority. For information about pamrevlumab studies currently recruiting patients, please visit www.clinicaltrials.gov.
About Duchenne Muscular Dystrophy
Duchenne muscular dystrophy (DMD) is a rare and debilitating neuromuscular disease that affects approximately 1 in every 5,000 newborn boys. About 20,000 children are diagnosed with DMD globally each year. The fatal disease is caused by a genetic mutation leading to the absence or defect of dystrophin, a protein necessary for normal muscle function. The absence of dystrophin results in muscle weakness, muscle loss, fibrosis, and inflammation. Patients with DMD are often wheelchair-bound before the age of 12, and their progressive muscle weakness may lead to serious medical problems relating to respiratory and cardiac muscle.
About FibroGen
FibroGen, Inc. is a biopharmaceutical company committed to discovering, developing, and commercializing a pipeline of first-in-class therapeutics. The Company applies its pioneering expertise in connective tissue growth factor (CTGF) biology and hypoxia-inducible factor (HIF) to advance innovative medicines for the treatment of unmet needs. Pamrevlumab, an anti-CTGF human monoclonal antibody, is in clinical development for the treatment of idiopathic pulmonary fibrosis (IPF), locally advanced unresectable pancreatic cancer (LAPC), metastatic pancreatic cancer, and Duchenne muscular dystrophy (DMD). Roxadustat (爱瑞卓®, EVRENZOTM) is currently approved in China, Japan, Europe, Chile, South Korea, and Russia for the treatment of anemia in CKD patients on dialysis and patients not on dialysis. Roxadustat is in Phase 3 clinical development in the U.S. and Europe for anemia associated with myelodysplastic syndromes (MDS), and in Phase 3 clinical development in China for treatment of chemotherapy-induced anemia (CIA). FibroGen recently expanded its research and development portfolio to include product candidates in the immuno-oncology and autoimmune space. 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 and commercialization of the company’s product candidates, the potential safety and efficacy profile of our product candidates, and our clinical programs. 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,” “will”, “should,” “on track,” “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, and other matters that are described in our Annual Report on Form 10-K for the fiscal year ended December 31, 2021 and our Quarterly Report on Form 10-Q for the quarter ended March 31, 2022, each as 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.
Contacts:
FibroGen, Inc.
Investors:
Michael Tung, M.D.
Corporate Strategy / Investor Relations
415.978.1434
mtung@fibrogen.com
Media:
Meichiel Keenan
Investor Relations and Corporate Communications
mkeenan@fibrogen.com
FAQ
What is the objective of the LELANTOS-2 trial for FGEN?
How many patients are enrolled in the LELANTOS-2 study?
When will the top-line data from the LELANTOS-2 trial be released?
What designations has pamrevlumab received from the FDA?
What is the primary endpoint of the LELANTOS-2 study?
