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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.

FibroGen Announces First Patient Enrolled In Pamrevlumab Phase 3 Clinical Trial In Patients With Duchenne Muscular Dystrophy