The stock price of InterMune Inc (NASDAQ:ITMN) surged more than 14% today after announcing that positive results of the clinical study of pirfenidone, its treatment for patients with idiopathic pulmonary fibrosis (IPF). The shares of the InterMune were trading $39.36 per share at the time of this writing around 11:46 A.M. today in New York.
IPF is a chronic, progressive and irreversible lung disease characterized by scarring in the lungs, which obstructs the ability person to breathe. People with IPF have an average survival period of two to five years from diagnosis, which makes the disease more lethal compared with many malignancies such as breast, ovarian and colorectal cancers.
Results of the study
According to InterMune Inc (NASDAQ:ITMN), the results from the Phase 3 ASCEND study evaluating pirfenidone in patients with IPF were presented by Dr. Talmadge King, professor and chair person of the department of medicine at the University of California, San Francisco and co-chair of the ASCEND protocol steering committee.
According to Dr. King, “Pirfenidone, as compared with placebo, reduced disease progression, as reflected by lung function, exercise tolerance, and progression-free survival in patients with idiopathic pulmonary fibrosis. Treatment was associated with an acceptable side effect profile and fewer deaths.”
The results of the study showed that 16.5% patients with IPF who received the pirfenidone treatment experienced a 10% decline or more in force vital capacity (FVC) or death at week 52 compared with 31.8% in the placebo group, which represents a 47.9% reduction in the proportion of patients who experienced the meaningful decline in FVC or death.
In addition, at Week 52, the results showed that 22.7% of patients in the pirfenidone group experienced no decline in FVC, compared with 9.7% in the placebo group, representing a 132.5% increase in the proportion of patients who experienced no decline in FVC between baseline and week 52.
“The compelling statistical result on the primary analysis was corroborated by supportive analyses, all of which resulted in similar conclusions. The results are very robust,” according to Dr. King.
InterMune to resubmit new drug application to FDA
Dan Welch, chairman, president and CEO of InterMune Inc (NASDAQ:ITMN), said the biotechnology company will resubmit a New Drug Application for pirfenidone to the U.S. Food and Drug Administration (FDA).
“The study results provide strong evidence of pirfenidone’s robust treatment effects and augment its already well-established safety and tolerability profile,” said Welch.
Canaccord Genuity analyst Ritu Barat told Bloomberg, “The data actually favors InterMune Inc (NASDAQ:ITMN). It’s incredibly important. This is their lead product.”