A Phase 3 trial investigating Boehringer Ingelheim’s nerandomilast in idiopathic pulmonary fibrosis hit its primary endpoint, according to topline data revealed Monday.
Based on the data, Boehringer said it is going to submit an NDA for the oral drug to the FDA and other regulatory agencies, but did not specify a timeline.
The company said its FIBRONEER-IPF trial met its primary endpoint of absolute change from baseline in forced vital capacity, a measure of lung function, at week 52 compared to placebo. But an investor note from Leerink Partners on Monday noted that the Boehringer press release did not mention the dose(s) that succeeded on the primary endpoint or the safety and tolerability profile of the investigational drug.
Despite the missing details, Leerink said the result was not only good for Boehringer, but also for Pliant Therapeutics and PureTech Health, which are developing therapies in this space. Pliant unveiled positive data from a mid-stage trial in May showing that the drug could potentially reverse fibrosis.
“In our opinion, this can be seen as a clearing event demonstrating that Phase 3 trials in IPF can succeed, providing a positive counter to the tough track record in IPF trials over the last several years,” Leerink analysts wrote Monday. “Our biggest outstanding question on BI’s drug is whether the safety profile of nerandomilast will be acceptable.”
Ioannis SapountzisBoehringer’s head of global therapeutic areas Ioannis Sapountzis said in a statement that this is the first idiopathic pulmonary fibrosis Phase 3 trial to meet its primary endpoint in a decade.
Full data from the trial will be shared in the first half of next year, including a key secondary endpoint: time to the first occurrence of acute idiopathic pulmonary fibrosis exacerbation, first hospitalization for respiratory cause or death.