Positive topline data reported in phase 3 trial of nerandomilast in progressive PF

Key takeaways:

• The double-blind, randomized, placebo-controlled phase 3 FIBRONEER-ILD trial achieved its primary endpoint.
• Boehringer Ingelheim expects to present full findings in quarter two of 2025.

Adults with progressive pulmonary fibrosis met the primary endpoint of absolute change in FVC with 52-week oral nerandomilast, an investigational phosphodiesterase 4B inhibitor, vs. placebo, according to FIBRONEER-ILD topline results.

“There remains a high unmet need for patients with progressive pulmonary fibrosis,” Jared Kurtz, BS, senior vice president, head of ILD & respiratory at Boehringer Ingelheim, told Healio.

Notably, Boehringer Ingelheim reported positive topline data in September 2024 for the phase 3 FIBRONEER-IPF trial, which examined the use of nerandomilast (BI 1015550, Boehringer Ingelheim) in adults with idiopathic pulmonary fibrosis.

In the double-blind, randomized, placebo-controlled phase 3 FIBRONEER-ILD trial, researchers assessed 1,178 adults with progressive pulmonary fibrosis to see how two twice-daily doses of oral nerandomilast (9 mg or 18 mg) perform against placebo when analyzing absolute changes in FVC after 52 weeks of treatment.

As Healio previously reported, a 12-week phase 2 trial found that treatment with an 18 mg dose of the phosphodiesterase 4B inhibitor in adults with IPF appeared to stabilize FVC regardless of background antifibrotic therapy, whereas the placebo group had reduced FVC.

Other outcomes of interest in the FIBRONEER-ILD trial included time to first acute ILD exacerbation, time to first respiratory cause hospitalization and mortality. Researchers plan to see which of the three happens first, according to the release.

At the moment, Boehringer Ingelheim has only said that the trial achieved its primary endpoint and that “initial safety and tolerability results of the FIBRONEER trials are generally consistent with the phase 2 results in IPF” in the topline data press release.

According to the release, Boehringer Ingelheim stated it will file a new drug application submission with the FDA.

“[This] announcement builds on Boehringer Ingelheim’s legacy and dedication in the research of this disease, and we look forward to sharing full efficacy and safety data from the trial in quarter two,” Kurtz told Healio.

Reference:

• A study to find out whether BI 1015550 improves lung function in people with progressive fibrosing interstitial lung diseases (PF-ILDs). https://clinicaltrials.gov/study/NCT05321082. Last updated Jan. 28, 2025. Accessed Feb. 11, 2025.