InterMune leaps on Esbriet data

InterMune Inc. (NASDAQ:ITMN) jumped $23.84 (171%) to $37.80 on Tuesday after reporting that daily Esbriet pirfenidone met the primary endpoint in the 555-patient Phase III ASCEND trial to treat idiopathic pulmonary fibrosis (IPF) -- a trial to support U.S. approval of the product in the indication. Esbriet improved the proportion of patients achieving a clinically meaningful percent change in forced vital capacity (FVC) from baseline at week 52 vs. placebo (p<0.000001). The company defined clinically meaningful as the proportion of patients experiencing a 10% or greater reduction from baseline in FVC or death vs. placebo; and the proportion of patients with no reduction in FVC from baseline vs. placebo (p<0.000001 for both definitions).

In a pre-specified analysis of pooled population of patients in ASCEND and InterMune's Phase III CAPACITY 1 and CAPACITY 2 trials, Esbriet reduced all-cause mortality (HR=0.52, p=0.0107) and treatment-emergent, IPF-related mortality (HR=0.32, p=0.0061) at week 52 vs. placebo. InterMune plans to present additional data from ASCEND at the American Thoracic Society International Conference in May. ...