InterMune, Inc. (Brisbane, CA) announced that enrollment of the CAPACITY clinical trials investigating pirfenidone in idiopathic pulmonary fibrosis (IPF) will be completed several months sooner than previous guidance due to stronger than expected patient enrollment, and that the Company will refine and expand the CAPACITY program to further enhance its ability to demonstrate clinically and statistically significant benefits for IPF patients.

"With CAPACITY enrollment significantly exceeding our expectations, we are in a position to expand the program and still complete it ahead of our previously announced timeline. We now expect patient enrollment to be completed in July of 2007 and the results of CAPACITY available in Q1 2009, several months ahead of our previous guidance," said Dan Welch, President and CEO of InterMune.

The refinements to the two Phase 3 trials in the CAPACITY program follow InterMune's review of two new and unique data sets related to: 1) changes in forced vital capacity (FVC) and other important measures of lung function over time in the placebo group of the recently un-blinded INSPIRE trial and 2) the effect of pirfenidone on vital capacity (VC) and other lung function parameters in the Phase 3 study of pirfenidone in IPF recently concluded by Shionogi & Co. in Japan. The planned changes to the CAPACITY program will increase the power of the studies to demonstrate statistically significant effects on the primary and secondary endpoint analyses. A total of 135 patients will be added to the previously planned 580 patients and the treatment duration will be increased by 12 weeks, from 60 to 72 weeks. The primary efficacy endpoint remains change in forced vital capacity (FVC). The increased sample size and treatment duration will provide in excess of 90% power to detect a 50% reduction in the rate of FVC progression after 72 weeks of treatment with pirfenidone compared to placebo and will also increase the power on the various secondary endpoints. Taking into account these changes, InterMune projects that the two trials will be fully enrolled with a total of 715 patients in July of 2007 and completed in the first quarter of 2009, several months ahead of previous guidance.

Steve Porter, M.D., Ph.D. and Chief Medical Officer of InterMune, said, "We have recently had the unique opportunity to review two new data sets from clinical studies in IPF that directly inform the design of our CAPACITY program: the INSPIRE study and the Phase 3 study of pirfenidone conducted by Shionogi in Japan. Based on our review of these data, we have refined the CAPACITY program to further enhance the probability of meeting its objectives. We are also pleased that as a result of very strong enrollment trends, we expect that we will complete the refined CAPACITY program well ahead of our previous projection. The study conduct in the CAPACITY program, which has experienced a low patient drop-out rate to date, is proceeding according to our plans.”

Source: InterMune press release 03/20/07: Content Edited for space