by: Parent Project Muscular Dystrophy
FibroGen, Inc. announced the initiation of LELANTOS, a Phase 3, randomized, double-blind, placebo-controlled trial of pamrevlumab or placebo in combination with systemic corticosteroids in patients with non-ambulatory Duchenne. PPMD is excited to see FibroGen’s continued progress and we appreciate them providing trial opportunities to our non-ambulatory population.
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Read the Announcement from FibroGen
FibroGen Announces First Patient Enrolled in Pamrevlumab Phase 3 Clinical Trial in Patients with Duchenne Muscular Dystrophy
SAN FRANCISCO, Aug. 11, 2020 (GLOBE NEWSWIRE) — FibroGen, Inc. (NASDAQ: FGEN) announced the initiation of LELANTOS, a Phase 3, randomized, double-blind, placebo-controlled trial of pamrevlumab or placebo in combination with systemic corticosteroids in patients with non-ambulatory Duchenne muscular dystrophy (DMD).
The primary objective of this global study is to evaluate the effect of pamrevlumab on muscle function in patients with DMD. Approximately 90 patients will be randomized 1:1 to receive pamrevlumab plus systemic corticosteroids, or placebo plus systemic corticosteroids, for up to 52 weeks. The primary efficacy endpoint is the change in the total score of performance of upper limb (PUL) assessment, from baseline to Week 52, and additional endpoints include pulmonary and cardiac function tests. Subjects who complete the 52-week study will be eligible for rollover into an open-label extension study with pamrevlumab and systemic corticosteroids.
“Duchenne muscular dystrophy is a progressive disease associated with muscle deterioration and weakness, often leading to patients becoming wheelchair-bound by the age of 12,” said Elias Kouchakji, M.D., Senior Vice President, Clinical Development, Drug Safety, and Pharmacovigilance, FibroGen. “In DMD, inhibition of connective tissue growth factor (CTGF) by pamrevlumab could result in decreased fibrosis in muscles leading to increased muscle function. We hope pamrevlumab provides a meaningful treatment for the patients with this debilitating disease.”
Pamrevlumab is a first-in-class antibody developed by FibroGen to inhibit the activity of CTGF, a common factor in fibrotic and proliferative disorders characterized by persistent and excessive scarring that can lead to organ dysfunction and failure. Importantly, skeletal muscle from DMD patients shows elevated levels of CTGF, and a major manifestation of DMD is cardiac fibrosis.
“Initiation of the LELANTOS Phase 3 clinical trial represents a key milestone for FibroGen and for our DMD clinical program, as well as an important development for the patients and families affected by Duchenne,” said Enrique Conterno, Chief Executive Officer, FibroGen. “We are grateful for the collaboration of global regulators, investigators, caregivers, and patients in enabling the conduct of this trial.”
About Pamrevlumab
Pamrevlumab is a first-in-class antibody developed by FibroGen that inhibits the activity of connective tissue growth factor (CTGF), a common factor in fibrotic and proliferative disorders. 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 clinical development for coronavirus (COVID-19). For information about pamrevlumab studies currently recruiting patients, please visit www.clinicaltrials.gov.
