FibroGen has announced the 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. 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.”Mark Eisner, M.D, M.P.H, Chief Medical Officer, FibroGen
A total of seventy-three (73) patients with Duchenne 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.
Top-line data from the LELANTOS-2 study is anticipated in the second half of 2023.
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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.