Topline results from LELANTOS-1 phase III clinical study of pamrevlumab in non-ambulatory patients with Duchenne muscular dystrophy
FibroGen, Inc.announced topline data from the Phase III LELANTOS-1 placebo-controlled trial of pamrevlumab for the treatment of non-ambulatory patients with Duchenne Muscular Dystrophy (DMD) on background corticosteroids
The study did not meet the primary endpoint of Performance of the Upper Limb 2.0 (PUL 2.0) score at week 52 compared to baseline. Pamrevlumab was generally safe and well tolerated and the majority of treatment emergent adverse events were mild or moderate.
FibroGen plans to present the complete results of the LELANTOS-1 study at an upcoming medical conference and to publish the full results. Topline data from the Phase III LELANTOS-2 clinical trial of pamrevlumab for the treatment of ambulatory patients with DMD is expected 3Q 2023.
“While disappointed with these results, we look forward to sharing the data at a future medical conference to contribute towards the understanding of this devastating disease,” said Enrique Conterno, Chief Executive Officer, FibroGen. “FibroGen would like to thank the patients, caregivers and clinical trial investigators for their dedication in participating in this study.”
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