Nerandomilast, an oral phosphodiesterase 4B inhibitor, hit the primary endpoint in a Phase III trial in progressive pulmonary fibrosis—nearly six months after achieving a similar feat in idiopathic pulmonary fibrosis. Boehringer plans to submit for FDA and other global approvals in both indications.
Boehringer Ingelheim recorded a second straight Phase III win Monday for its drug nerandomilast, which met the primary endpoint in the FIBRONEER™-ILD trial in progressive pulmonary fibrosis—months after reporting a similar result in idiopathic pulmonary fibrosis.
Topline data from FIBRONEER™-ILD showed nerandomilast hit the primary endpoint of absolute change from baseline in forced vital capacity, a measure of lung function, at week 52 versus placebo. The results come nearly six months after nerandomilast, an oral, preferential inhibitor of phosphodiesterase 4B, showed it could significantly improve lung function in idiopathic pulmonary fibrosis (IPF) in the Phase III FIBRONEER-IPF study.
FIBRONEER-IPF was “the first IPF Phase III trial in a decade to meet its primary endpoint,” Ioannis Sapountzis, Boehringer’s head of global therapeutic areas, said in a statement in September 2024.
Initial data from both studies “support a generally consistent safety and tolerability profile,” comparable to Boehringer’s Phase II IPF study, according to the company’s press release. Overall adverse events were comparable to those seen in the placebo group.
As was the case in September, Boehringer did not provide specific data, only saying that full efficacy and safety data would be shared in the second quarter of this year.
On the strength of these data, Boehringer plans to submit a New Drug Application (NDA) for nerandomilast in progressive pulmonary fibrosis to the FDA and other global health authorities. The company also plans to submit an NDA in IPF.
In a statement Monday, Shashank Deshpande, head of Human Pharma and a member of the Board of Managing Directors at Boehringer, touted the drug’s safety profile. “The hope is that the safety and tolerability profile we are initially seeing could potentially help to reduce treatment challenges,” Deshpande said.
Boehringer isn’t the only company to succeed in pulmonary fibrosis in the past year. Days after Boehringer’s successful FIBRONEER-IPF readout, Insilico Medicine reported that its generative AI–designed IPF treatment ISM001-055 met the primary endpoint of safety and secondary efficacy endpoints in a small Phase IIa trial, demonstrating a dose-dependent improvement in forced vital capacity over 12 weeks. The biotech followed that up in November with positive results from another Phase IIa trial, in which ISM001-055 improved lung function and was well-tolerated across all dosing groups.
It wasn’t all good news on the pulmonary fibrosis front Monday, however, as Pliant Therapeutics suspended dosing and enrollment in the Phase IIb/III BEACON-IPF study of its IPF drug candidate bexotegrast after encountering safety issues. The voluntary pause follows a prespecified data review by an independent data safety monitoring board, according to Pliant’s announcement.
