BI, InterMune tout lung drugs
Boehringer Ingelheim's efforts to be a major player in the idiophathic pulmonary fibrosis market look poised to take off. The company announced results from its two Phase-III INPULSIS trials Sunday that the experimental drug nintedanib reduced the annual rate of decline in forced vital capacity among patients over a 52-week period.
BI said the results showed this result among 48% of INPULSIS-I clinical trial patients and 55% of INPULSIS-2 clinical trial patients.
The timing was somewhat serendipitous, appearing the same day that the National Institutes of Health announced that a clinical trial using already-approved and used prednisone and azathioprine with N-acetylcysteine did not slow progression of the disease, which usually kills patients two to three years after diagnosis. The NIH said that the trials proved that adding N-acetylcysteine to treatments did not slow progression, which was long thought to be the case.
The chronic, progressive lung condition scars the lungs, which leaves patients increasingly short of breath, fatigued, coughing and in pain.
Boehringer is set to present its information as a late-breaking presentation Tuesday at the American Thoracic Society International Conference, and may have to elbow for some attention, since InterMune also reported positive results Sunday. In this case, it was Phase-III data about its drug pirfenidone, which has been approved by the European Commission, but not by the FDA.
InterMune's ASCEND study showed a significant reduction in lung-function loss among patients during a 52-week period. The study also found improvement in secondary endpoints, such as a change in the six-minute walking distance test and progression-free survival, but missed when it came to the target result for shortness of breath, known as dyspnea.
Jefferies analyst Eun Yang wrote in a Monday research note that pulmonologists attending the American Thoracic Society conference view data for the two drugs as similar, but with a slightly greater appreciation for InterMune's pirfenidone. Yang wrote that 30% to 40% of polled specialists favored pirfenidone, and 10% to 20% favored BI's nintedanib.