InterMune, Inc. said it would initiate an open-label roll-over study to evaluate the long-term safety of pirfenidone in patients with idiopathic pulmonary fibrosis (IPF). The roll-over study will be open to patients who complete one of the two concurrent phase III Capacity studies of pirfenidone in IPF. InterMune expects that the first patient will enter the roll-over study in August 2008.
Regarding the progress of Capacity, the company noted that patient retention and overall study conduct remain excellent, with a low rate of patient dropouts to date. InterMune anticipates that top-line results from CAPACITY will be available in January 2009. Data from the Capacity trials will remain blinded during the extension study enrolment period.
The company also provided an update on the publication plans of Shionogi concerning its phase III study of pirfenidone in IPF performed in Japan.
Idiopathic pulmonary fibrosis (IPF) is a disabling and ultimately fatal disease that affects a total of approximately 200,000 people in the United States and Europe, with approximately 30,000 new cases developing in the United States alone, each year. There are no medicines approved by the US Food and Drug Administration (FDA) or European Medicines Evaluation Agency (EMEA) for the treatment of IPF, the company informed in a press release. IPF is characterized by inflammation and scarring (fibrosis) in the lungs, hindering the ability to process oxygen and causing shortness of breath (dyspnea) and cough. IPF is a progressive disease, meaning that over time, lung scarring and symptoms increase in severity. The median survival time from diagnosis is two to five years.
Prior in vitro evidence has shown that pirfenidone inhibits collagen synthesis, down-regulates profibrotic cytokines and decreases fibroblast proliferation. Data presented from one phase III study and four phase II clinical trials in more than 400 patients suggest that pirfenidone may positively affect lung function and disease progression in patients with IPF. In these clinical studies, pirfenidone was generally well tolerated with the most frequent side effects reported being photosensitivity rash and gastrointestinal symptoms. Pirfenidone has been granted orphan drug designation in the both the United States and Europe for the treatment of IPF.