FibroGen, Inc (NASDAQ: FGEN) released positive Phase 2 results yesterday, prompting a 50% jump in their stock price Tuesday.
The pharmaceutical company released positive topline results of Idiopathic Pulmonary Fibrosis drug Pamrevlumab, citing a randomized, double-blind, placebo-controlled study and two combination safety sub-studies, according to the press release. Luca Richeldi, M.D., Ph.D., Head of the Division of Pulmonary Medicine at Agostino Gemelli University Hospital of the Catholic University of the Sacred Heart in Rome, Italy, said, “I am pleased to see positive Phase 2 results with pamrevlumab -- an antibody against CTGF, a new target in fibrosis -- which has a good safety profile and the potential to provide alternative, much-needed new treatment options for IPF patients.” The main concern was with the decrease of forced vital capacity in the lungs, the new drug proved to provide an average decrease in FVC of 129ml after 48 weeks of trials, whereas those patients receiving placebo were recorded to have lost 308ml of FVC in the same timeframe.
FibroGen has decided to move forward with Phase 3 trials for the drug. Pamrevlumab was also found to be effective and well tolerated when combined with other drugs such as pirfenidone and nintedanib.
As for the FDA, the company will wait to present these results in the 2017 European Respiratory Society International Congress and thereafter work towards getting the necessary approvals.