Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Californian biotech InterMune has begun patient enrollment in its phase III clinical program to evaluate pirfenidone as a treatment for patients with idiopathic pulmonary fibrosis.
Subscribe to our email newsletter
InterMune said that it would be running two phase III trials, designed to evaluate the safety and efficacy of pirfenidone in idiopathic pulmonary fibrosis (IPF) patients with mild to moderate impairment in lung function. The primary endpoint of both trials is lung function, as measured by change in forced vital capacity.
The two trials have enrolled a total of 779 patients at 110 centers in North America and Europe. Enrollment was completed in less than 13 months following randomization of the first patient into the program in late April 2006. InterMune said results from the studies are expected by the end of 2008.
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. The disease affects approximately 83,000 people in the US, with approximately 30,000 new cases developing each year. There are no drugs approved by the FDA or EMEA for the treatment of IPF.