- Shares of San Francisco biotech FibroGen, Inc. jumped more than 45% in early trading Tuesday, spurred by positive results announced by the company Monday evening for its idiopathic pulmonary fibrosis (IPF) drug.
- The 48-week Phase 2 study showed that pamrevlumab, an anti-connective tissue growth factor (CTGF) antibody, had a statistically significant improvement in lung function in the 103-patient study when compared with placebo.
- Patients in the pamrevlumab arm of the trial showed an average decline in forced vital capacity percent (FVC%) of 2.85 compared with 7.17 for those in the placebo group.
Investors were thrilled with data from the mid-stage study that showed FibroGen's lung drug could both outperform a placebo and be used in conjunction with other IPF agents.
Aside from the main study, the company conducted a basket of smaller sub-studies to test the performance of pamrevlumab in conjunction with several commonly used treatments in the space, including Roche's Esbriet (pirfenidone) and Boehringer Ingelheim's Ofev (nintedanib).
The company said it will present further data from the studies at an upcoming medical meeting in September and is planning to meet with the Food and Drug Administration to "address the clinical and regulatory path forward for pamrevlumab in this indication," the company said in a statement. FibroGen CEO Tom Neff said on an earnings call with investors that he expects to move the program into Phase 3.
"For clarity, I should point out that we chose to use the random coefficient linear regression model similar to the methodology employed by Boehringer Ingelheim in their Phase 3 U.S. study of nintedanib," added Neff. "We chose this method because according to published FDA clinical and statistical reviewer comments after the BI Phase 3 made it clear that this approach is acceptable or not controversial."