US-based biotechnology company FibroGen Inc. (NASDAQ: FGEN), which maintains significant operations in China, is initiating damage control measures following the failure of two late-stage trials for its potential first-in-class anti-connective tissue growth factor (CTGF) fully human monoclonal antibody, pamrevlumab. In response to these setbacks, FibroGen has decided to terminate all development of pamrevlumab and is planning a significant reduction in its workforce, with approximately 75% of staff to be cut as part of a corporate restructuring.
The failed trials included the Pancreatic Cancer Action Network’s (PanCAN) Precision Promise Phase II/III adaptive platform trial, which evaluated pamrevlumab in combination with gemcitabine + nab-paclitaxel for first-line and second-line metastatic pancreatic ductal adenocarcinoma (mPDAC) patients. The primary endpoint of overall survival (OS) was not achieved. Additionally, FibroGen’s Phase III LAPIS trial, which compared pamrevlumab combined with gemcitabine + nab-paclitaxel or FOLFIRINOX to placebo for the treatment of locally advanced, unresectable pancreatic cancer (LAPC), also failed to meet its primary endpoint of improved OS.
As a result of these outcomes, FibroGen will immediately cease the development program for pamrevlumab and embark on a cost-reduction initiative that includes a substantial reduction in its US workforce. The company is currently marketing roxadustat, an anemia therapy, and has emphasized that its existing partnerships with AstraZeneca for China and with Astellas for the EU, Japan, and other territories will remain unaffected.- Flcube.com
