FibroGen’s Pamrevlumab Fails Phase 3

FibroGen says its pamrevlumab did not meet the primary endpoint in the Phase 3 LELANTOS-1 trial in treating non-ambulatory patients with Duchenne Muscular Dystrophy (DMD) on background corticosteroids. A company statement says pamrevlumab was generally safe and well tolerated and the majority of treatment-emergent events were mild or moderate.

Pamrevlumab is described as a potential first-in-class antibody being developed to inhibit the activity of connective tissue growth factor.

FDA has granted rare pediatric disease, orphan drug, and fast track designations to the drug to treat DMD.

The company says topline data from the Phase 3 LELANTOS-2 trial of pamrevulab to treat ambulatory patients with DMD are expected in the third quarter.

“While disappointed with these results,” says FibroGen CEO Enrique Contero, “we look forward to sharing the data at a future medical conference to contribute towards the understanding of this devastating disease.”