By Chris Wack
FibroGen’s shares have dropped significantly after the company reported that its recent trial for pamrevlumab has failed to meet its target. The Phase 3 trial focused on idiopathic pulmonary fibrosis patients and compared treatment with pamrevlumab to a placebo over 48 weeks. However, it failed to meet the primary endpoint of a change in forced vital capacity. Additionally, the time-to-disease progression secondary endpoint was also not met.
Despite the negative result, FibroGen maintains that pamrevlumab remains generally safe and well-tolerated. While treatment-emergent serious adverse events were observed in both the pamrevlumab and placebo groups, the majority of adverse events were classified as mild or moderate.
As a result of these findings, FibroGen will be discontinuing their second Phase 3 clinical trial. To offset losses and extend its financial runway into 2026, FibroGen has also expressed plans to reduce costs significantly within the U.S.
It remains to be seen what effect these developments will have on their current product offerings and standing in the industry.
FibroGen hit a setback after reporting that its Phase 3 trial did not meet expectations. This is a significant blow to both the company and those who suffer from idiopathic pulmonary fibrosis. Although still safe and well-tolerated, it’s clear that FibroGen will need to reassess its clinical trial approach to develop effective treatments in the future.