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Nerandomilast Meets Primary Endpoint in Improving FVC in Progressive Pulmonary Fibrosis
Boehringer plans to soon submit a new drug application for nerandomilast for treating PPF to the FDA.
Nerandomilast significantly improved forced vital capacity (FVC) in people with progressive pulmonary fibrosis (PPF) compared to placebo, meeting the primary endpoint in the phase 3 FIBRONEER-ILD trial.1
According to their February 10, 2025 announcement, Boehringer Ingelheim plans to submit a new drug application for nerandomilast for treating PPF to the FDA as well as applications to other regulatory agencies around the world.
“The positive FIBRONEER™-ILD topline result shows the potential of nerandomilast in PPF. The hope is that the safety and tolerability profile we are initially seeing could potentially help to reduce treatment challenges,” Shashank Deshpande, Head of Human Pharma and Member of the Board of Managing Directors at Boehringer Ingelheim, said in a statement.1 “The recent milestones of the FIBRONEER™ trial program underscore our commitment to transforming the lives of patients with this debilitating disease, and are a testament to Boehringer Ingelheim's position at the forefront of pulmonary fibrosis research.”
Nerandomilast is an investigational oral, preferential inhibitor of phosphodiesterase 4B (PDE4B). FIBRONEER-ILD’s primary endpoint was the absolute change from baseline in FVC in milliliters at week 52 versus placebo in patients receiving nerandomilast. The trial demonstrates continued safety and tolerability of nerandomilast which is comparable to phase 2 data of the therapy in idiopathic pulmonary fibrosis and an overall adverse event profile comparable to those seen in the placebo group.2 Boehringer expects to share full efficacy and safety data from FIBRONEER-ILD in the second quarter of 2025.
The FIBRONEER-ILD trial treated patients with PPF with either oral nerandomilast 9 mg or 18 mg, or placebo, twice-daily, over at least 52 weeks. The 18 mg dose was informed by phase 2 study data, and the 9 mg dose was added to evaluate the benefit-risk profile at a lower dose. Secondary endpoints included time to the first occurrence of any of the components of the composite endpoint: time to first acute interstitial lung disease (ILD) exacerbation; first hospitalization for respiratory cause; or death (whichever occurs first) over the duration of the trial. The trial was conducted in more than 1178 patients across 400 locations in 40 countries.1
FIBRONEER-ILD is the second Phase 3 trial in which the nerandomilast has met its primary endpoint, following the FIBRONEER-IPF (NCT05321069) trial in the FIBRONEER program.3 The trials had the same primary and secondary endpoints, but differed in study populations of IPF and PPF.
