More than three years after the FDA sent InterMune back to the clinic for another Phase III study of its lung drug pirfenidone--Esbriet--for idiopathic pulmonary fibrosis, the biotech says it scored a win on the primary as well as two secondary endpoints for the lung-scarring treatment. And now InterMune ($ITMN) says it's ready to go back to the FDA and lay out the data, hoping for an approval that will greatly expand the market for a drug now sold in Europe.
The trial demonstrated that pirfenidone "significantly reduced IPF disease progression as measured by change in percent predicted forced vital capacity (FVC) from baseline to week 52," the company said in a release. And it hit the marks for a 6-minute walk test as well as the score on progression-free survival.
That looked like a big green light to investors, who quickly bid up the value of Intermune's shares by a whopping 163% on Tuesday morning.
Investigators went looking for an improvement in the rate of decline in FVC to qualify as a significant advantage for patients. After a year of therapy, 16.5% of patients taking the drug experienced a 10% decline in FVC, or died. That compares with a 31.8% rate in the placebo arm. Also, 22.7% of patients in the pirfenidone arm had no drop in FVC, compared with only 9.7% in the placebo group.
InterMune has alternately been both the love child of Wall Street as well as its whipping boy. Periodically red-hot rumors of a likely takeover, sometimes spurred by Bloomberg reports, have triggered huge spikes in the company's stock price. But just days ago the company's shares took a beating on reports that Boehringer Ingelheim could be a potential competitor following the launch of late-stage studies for the disease.
Today, though, the news clearly favors InterMune.
"IPF is an unpredictable, debilitating and ultimately fatal disease, and safe and effective treatments are desperately needed to alter the course of this challenging and complex condition," said Dr. Talmadge King, chair of the department of medicine at the University of California, San Francisco, in a statement. "The ASCEND data demonstrated that pirfenidone significantly reduced decline in lung function and significantly increased the proportion of patients who had no decline, which is an important advance in the field. The results for 6MWT distance, PFS and mortality provide important supportive evidence of pirfenidone's efficacy."
- here's the release
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