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Pirfenidone Delays Progression of Pulmonary Fibrosis in Late-Stage Study
Progression-free survival significantly improved versus placebo (February 25)
Positive results have been reported from the phase III ASCEND trial, which evaluated pirfenidone (InterMune, Inc.) in patients with idiopathic pulmonary fibrosis (IPF).
Pirfenidone significantly reduced IPF disease progression, as measured by the change in percent predicted forced vital capacity (FVC), from baseline to week 52 (rank ANCOVA P < 0.000001). In addition, significant treatment effects were demonstrated on both of the key secondary endpoints: the change in the 6-minute walk test distance (6MWD) and progression-free survival (P = 0.0360 and P = 0.0001, respectively).
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. Further, at week 52 the data showed 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.
Pirfenidone is an orally active anti-fibrotic agent that inhibits the synthesis of transforming growth factor-beta (TGF-beta), a chemical mediator that controls many cell functions, including proliferation and differentiation, and plays a key role in fibrosis. Pirfenidone also inhibits the synthesis of tumor necrosis factor-alpha (TNF-alpha), a cytokine that is known to have an active role in inflammation.
The drug is available in Europe, Canada, and Japan, but is not approved for sale in the U.S.
Source: InterMune, Inc.; February 25, 2013.