FibroGen has implemented cost reduction measures in the US as two Phase III trials investigating the company’s lead oncology candidate pamrevlumab failed to meet their primary endpoints.
The company plans to suspend the development of pamrevlumab and fire 75% of its US workforce. Following the announcement, FibroGen’s shares took a nosedive and dropped by approximately 40% in premarket trading today, compared to the market close on the previous day.
The combination treatment of pamrevlumab and chemotherapy failed to meet the primary endpoint of overall survival in patients with locally advanced, unresectable pancreatic cancer in the Phase III LAPIS trial (NCT03941093). The same combination treatment also failed to achieve the primary endpoint of overall survival in patients with metastatic pancreatic ductal adenocarcinoma in a Phase II/III PanCAN’s Precision Promise trial (NCT04229004).
FibroGen has not seen any late-stage success with pamrevlumab, with the therapy also failing to show efficacy in patients with Duchenne muscular dystrophy (DMD). Last year, the company announced disappointing results from two Phase III trials in DMD patients, after both failed to meet primary endpoints.
Pamrevlumab is a monoclonal antibody that inhibits the activity of connective tissue growth factor (CTGF), which is involved in multiple tumour development and tissue fibrosis pathologies.
The company added that whilst it is winding down R&D activities for pamrevlumab, the commercial agreements for its anaemia therapy, roxadustat, will remain in place. Astellas holds the development and commercialisation rights to roxadustat in Japan, Europe, Turkey, Russia, the Commonwealth of Independent States, the Middle East, and South Africa.
FibroGen has licensed roxadustat’s commercial rights in China and South Korea to AstraZeneca, where the drug is approved under the brand name Evrenzo. The company is expecting an approval decision for roxadustat in chemotherapy-induced anaemia (CIA) in China in H2 2024, which, if positive, will trigger a $10m milestone payment from AstraZeneca.
Another oncology candidate in FIbroGen’s pipeline is a CD-46 targeting antibody-drug conjugate (ADC), FG-3246. The company licensed the therapy from Fortis Therapeutics in May 2023.
In April, the company reported positive data from a Fortis-sponsored Phase I trial (NCT03575819) of the therapy involving metastatic castration-resistant prostate cancer patients. It demonstrated a median progression-free survival of 8.7 months and a prostate-specific antigen decrease of 50% or more in 36% of participants.
