FibroGen shares lost ~86% pre-market Monday after the company announced that its Phase 3 ZEPHYRUS-1 trial for pamrevlumab for the chronic lung disorder idiopathic pulmonary fibrosis (IPF) didn’t reach its main goals.
Given the setback, FibroGen (FGEN) has decided to discontinue ZEPHYRUS-1 and ZEPHYRUS-2, a second Phase 3 clinical trial for the candidate.
Additionally, the San Francisco, California-based biotech announced plans to implement a cost-reduction initiative in the U.S. in an effort to extend its cash runway into 2026.
The 356-patient ZEPHYRUS-1 trial was designed to evaluate pamrevlumab against placebo over 48 weeks in IPF patients.
The study didn’t reach the primary endpoint of change from baseline in forced vital capacity (FVC), as the mean decline in FVC stood at 260 ml in the pamrevlumab arm while those on placebo indicated a 330 ml decline at Week 48 (p = 0.29).
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