Significance of New Nerandomilast Findings for Pulmonary Fibrosis, with Toby Maher, MD, PhD

New phase 3 findings presented at the American Thoracic Society (ATS) International Conference, drawn from the FIBRONEER-IPF and FIBRONEER-ILD studies, indicated that nerandomilast met its primary endpoint in both studies assessing patients with idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF).1

The late-breaking data on nerandomilast, an investigational oral and preferential inhibitor of phosphodiesterase 4B (PDE4B), were previously highlighted by HCPLive. The findings were discussed by trial investigator and professor of Clinical Medicine at USC’s Keck School of Medicine, Toby Maher, MD, PhD, who spoke with the HCPLive editorial team about the data’s significance for patients with IPF and PPF.

“The two FIBRONEER trials were very similar in design, with both studies looking at a primary endpoint of change in [forced vital capacity] over 52 weeks,” Maher explained. “Both studies compared 2 active doses of nerandomilast to placebo, so 18 milligrams and 9 milligrams. Both studies continue to follow patients beyond 52 weeks…The key finding in both trials, both doses of nerandomilast slowed the rate of FVC decline compared to placebo. The reason why we think that is important is that FVC is essentially a surrogate for survival. So we think that means that patients treated long term will live longer.”

Nerandomilast showed significant efficacy in the reduction of forced vital capacity (FVC) decline in those with IPF and PPF over 52 weeks of use. Rates of drug discontinuation due to adverse events were also found to be comparable between nerandomilast and placebo cohorts in both of the studies.

“With the [FVC] reduction across the 2 studies, there's just 1 little wrinkle to be aware of,” Maher said. “Which is that there was an unexpected drug interaction with the pirfenidone in the IPF study, resulting in patients essentially getting a lower dose of nerandomilast than anticipated. That has led to a slight underestimate, I think, of the treatment effect. But that notwithstanding, in the IPF study, we saw about a 35 to 38% reduction in the rate of FVC decline. In the PPF study, we were seeing around a 40 to 45% reduction in FVC…What I anticipate that means for patients is that they should be able to live longer with their disease, and that not only hopefully, will they live longer, but it will also delay important events like respiratory failure, the need for oxygen, etc.”

For additional information on late-breaking data presented at ATS, view the latest conference coverage.

The quotes in this interview summary were edited for clarity.

Maher has previously reported receiving personal fees from Boehringer Ingelheim, Galapagos, Roche/Genentech, Pfizer, BMS, GSK, Sanofi-Aventis, Pliant, Trevi, Galecto, Merck, Astra Zeneca, CSL Behring, Vicore, Scleroderma Research Foundation, Qureight, and Veracyte.

References

1. Global phase III trials demonstrate that nerandomilast slowed lung function decline in IPF and PPF, with similar discontinuation rates to placebo. Boehringer Ingelheim. May 19, 2025. Accessed May 23, 2025. https://www.boehringer-ingelheim.com/human-health/lung-diseases/pulmonary-fibrosis/phase-3-trials-nerandomilast-slowed-lung-function-decline-ipf-and-ppf.