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FibroGen Misses In First Of Two Pivotal DMD Trials

 
• By Joseph Haas

The biotech’s pamrevlumab fails a Phase III study in non-ambulatory Duchenne muscular dystrophy, but the antibody still has a shot in ambulatory DMD, as well as IPF and pancreatic cancer.

Shot on goal
Despite miss in DMD, FibroGen has other shots on goal with pamrevlumab • Source: Shutterstock

It was a second clinical trial disappointment in as many months for FibroGen, Inc. as the San Francisco-based firm revealed on 7 June that its CTGF-targeted antibody pamrevlumab missed the primary endpoint in the first of two Phase III studies in Duchenne muscular dystrophy (DMD). The failure was in non-ambulatory DMD patients, but a second Phase III study of the candidate in ambulatory DMD patients is expected to report data during Q3.

The readout followed FibroGen’s 5 May announcement that second-generation hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor roxadustat missed its primary endpoint of red blood cell transfusion independence in myelodysplastic syndrome-related anemia in the Phase III MATTERHORN study. (Also see "FibroGen’s Roxadustat On The Rocks After Phase III Myelodysplastic Syndrome Failure" - Scrip, 5 May, 2023

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