Safety Findings on Nerandomilast for Pulmonary Fibrosis, with Toby Maher, MD, PhD

In an interview at the American Thoracic Society (ATS) International Conference, discussing the phase 3 FIBRONEER-IPF and FIBRONEER-ILD studies, Toby Maher, MD, PhD, described nerandomilast’s success in achieving its primary endpoint in both trials on patients with idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF).1

After discussing some of the most notable findings in these late-breaking data on the investigational oral phosphodiesterase 4B (PDE4B) inhibitor, the FIBRONEER trial investigator and professor of Clinical Medicine at USC’s Keck School of Medicine spoke with HCPLive about nerandomilast’s safety findings in the analyses.

In addition to nerandomilast’s efficacy demonstrated by the reduction of forced vital capacity (FVC) in those with IPF and PPF over 52 weeks of medication use, discontinuation rates due to adverse events were also noted as having been comparable between nerandomilast and placebo cohorts in both of trials.

“I think it is an important observation that the discontinuation rates are similar across all 3 arms, including the placebo arm,” Maher said. “We know that IPF trials are difficult for patients. They're committing to over a year of being in the study. Life events come up, and disease related events come up. So we always expect some patients to discontinue. In the past, when we've used difficult to tolerate drugs, we've seen a very clear increase in discontinuations in the active treatment arm. The fact that we're not seeing that in this study, to me, reinforces the idea that nerandomilast is a much easier drug for patients to tolerate. I'm hoping that that is going to make life a lot easier in clinical practice.”

Maher was also asked about the future of nerandomilast for IPF and PPF, given the positive findings in the FIBRONEER trial program presented at ATS.

“Hopefully the regulatory bodies, the FDA, will look very favorably upon this data,” Maher said. “I'm very optimistic that the drug will hopefully be approved in the near future for use in clinical practice. You know, this trial was designed to test the effect of nerandomilast in an environment where we have anti-fibrotic drugs. We know that it slows disease progression, and we know that it can be used safely in combination with existing treatments.”

Maher added that what is not yet present is evidence on is whether clinicians should be thinking about upfront combinations of drugs.

“I think that is something that we need to look at in the future,” Maher said. “Similarly, we don't have data on when it is a new drug should be added on, so I think there are things for us to still tease out and understand about the position of nerandomilast within treatment and how we now think about treating IPF and PPF when we have drugs that can be used in combination.”

To find out any additional information on recent data presented at ATS, view our latest conference coverage.

The quotes used in this summary were edited for the purposes of clarity.

Maher 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.