Biotechnology stocks have been on quite a roll over the last few weeks, with news of buyouts and mergers driving biotech indices close to all-time highs. The hot roll for biotech continued today, with InterMune Inc (NASDAQ:ITMN) reporting positive Phase III clinical trial results for its drug pirfenidone in patients with idiopathic pulmonary fibrosis. The results showed that pirfenidone significantly reduced IPF disease progression with reference to change in percent predicted forced vital capacity from Baseline to Week 52. Currently available treatments for IPF only offer limited benefits to patients.
InterMune Inc (NASDAQ:ITMN) stock has traded up by as much as 174% today after the release of the positive trial data. As of 3 PM ET, the high for the day was $38.22.
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InterMune’s Perfenidone Phase III clinical trial top line results
The InterMune Inc (NASDAQ:ITMN) statement released today said that pirfenidone met both primary and secondary endpoints. For background, a 10% decline in forced vital capacity (FVC) is generally considered clinically meaningful. However, only 16.5% of patients taking pirfenidone after 52 weeks suffered a 10% decline in FVC, or died, compared to 31.8% in the placebo group. This stunning efficacy provides a 48% reduction over the control arm for the pirfenidone intent-to-treat group. Furthermore, 22.7 percent of patients in perfenidone arm during the trial experienced no drop off in lung function (compared to 9.7% of placebo arm).
For the secondary endpoint, according to the company statement, pirfendone “reduced by 27.5% the proportion of patients who experienced a decline in the [six-minute-walking-distance test] of 50 meters of greater.” This test was designed to measure patient exercise tolerance since the treatment was initiated. Overall, pirfenidone reduced the risk of death or disease progression by 43% relative to the control arm.
Drug already in use elsewhere, but US market significant
Previous trials had yielded mixed results and the FDA has refused to approve the drug to date. InterMune plans to resubmit pirfenidone for FDA approval in the third quarter. The compound is already in use for IPF in Europe and Canada, where it is called Esbriet. It has also an approved drug in Japan, South Korea, China, India, Argentina and Mexico. Analysts have commented the U.S. market represents a very significant increase in pirfenidone sales.