BRISBANE, Calif. — An investigational drug made by InterMune improved breathing in patients with a rare and fatal lung disease, according to results of a late-stage clinical trial published online in The Lancet last week.
InterMune is investigating the drug pirfenidone as a treatment for idiopathic pulmonary fibrosis, which affects more than 200,000 patients in the European Union and the United States combined. Only 20% of patients with IPF survive after five years.
“These newly published data document the favorable risk-benefit profile of pirfenidone in patients with IPF, consistent with the recent approval by the European Medicines Agency of pirfenidone for these patients,” lead study author and Duke University professor of medicine Paul Noble said. “Although the results of Study 004 and 006 were not identical, and only Study 004 achieved the primary endpoint, the totality of the data provides compelling evidence of a clinically meaningful treatment effect of pirfenidone, together with a favorable safety profile of patients with IPF.”
Trial results showed that the drug reduced the decline in patients’ forced vital capacity, or FVC, an important measure of lung function, compared with placebo, and also reduced the decline in the distance patients could walk in six minutes, another measure of lung function.