Updated from 7:41 am ET with new information and analysis.
InterMune (ITMN) announced Tuesday very strong and positive results from the phase III "Ascend" study of pirfenidone in idiopathic pulmonary fibrosis (IPF). Pirfenidone improved lung function and slowed the progression of IPF -- meeting the study's primary and key secondary endpoints.
Based on these positive data, InterMune intends to file for FDA approval of pirfenidone in the third quarter, the company said Tuesday.
InterMune shares rose 121% to $30.80 in Tuesday trading.
Here's how InterMune described the primary endpoint analysis of the pirfenidone study:
The magnitude of the treatment effect of pirfenidone was measured by comparing the proportion of patients in the pirfenidone and placebo groups experiencing either a clinically meaningful change in FVC, or death. A 10% decline in FVC in an individual IPF patient is considered clinically meaningful and strongly predicts mortality. At Week 52, 16.5% of patients in the pirfenidone group experienced an FVC decline of 10% or more or death, compared with 31.8% in the placebo group, representing a 47.9% reduction in the proportion of patients who experienced a meaningful change in FVC or death. Additionally, at Week 52 the data demonstrated that 22.7% of patients in the pirfenidone group experienced no decline in FVC, compared with 9.7% in the placebo group, representing a 132.5% increase in the proportion of patients whose FVC did not decrease between Baseline and Week 52.
It's easier to understand the strength of these pirfenidone data by looking at the results graphically: