FibroGen: Phase 3 ZEPHYRUS-1 Study Of Pamrevlumab Fails To Meet Endpoints

(RTTNews) - FibroGen, Inc. (FGEN) reported topline results from Phase 3 ZEPHYRUS-1 trial evaluating the safety and efficacy of pamrevlumab in patients with idiopathic pulmonary fibrosis. The study compared treatment with pamrevlumab to placebo and did not meet the primary endpoint of change from baseline in forced vital capacity at week 48. The secondary endpoint was also not met, the company noted. In the safety analysis, pamrevlumab was generally safe and well tolerated.

FibroGen stated that, based on the results of ZEPHYRUS-1, ZEPHYRUS-2, the second Phase 3 clinical trial, will be discontinued.

The company plans to implement a significant cost reduction effort in the U.S. with the intent to extend cash runway into 2026.

"FibroGen's focus will be on reporting the additional pamrevlumab studies, advancing our pipeline, and continuing commercialization of roxadustat in China and in countries where approved," said Enrique Conterno, CEO, FibroGen.

Shares of FibroGen are down 76% in pre-market trade on Monday.

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