Positive topline data reported in phase 3 trial of nerandomilast in adults with IPF

Key takeaways:

• The double-blind, randomized, placebo-controlled phase 3 FIBRONEER-IPF trial achieved its primary endpoint.
• Boehringer Ingelheim expects to present full findings in the first 6 months of 2025.

Adults with idiopathic 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-IPF topline results.

“This is the first IPF phase 3 trial in a decade to meet its primary endpoint,” Ioannis Sapountzis, PhD, head of global therapeutic areas at Boehringer Ingelheim, said in a press release, adding that the announcement represents the next step in the company’s long history in researching this disease.

“IPF has a high unmet need for patients, and we are continuously fostering our research activities to develop more options for one of the most common interstitial lung diseases,” Sapountzis continued.

As Healio previously reported, the FDA granted breakthrough designation to BI 1015550 (nerandomilast, Boehringer Ingelheim) for treating patients with IPF.

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

In the double-blind, randomized, placebo-controlled phase 3 FIBRONEER-IPF trial, researchers assessed 1,177 adults aged 40 years or older with IPF 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.

Other outcomes of interest included time to first acute IPF 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 in the topline data press release.

According to the release, Boehringer Ingelheim stated it will make a new drug application submission to the FDA and expects to present full FIBRONEER-IPF findings in the first 6 months of 2025.

Notably, researchers are also assessing the use of nerandomilast in patients with progressive pulmonary fibrosis in the phase 3 FIBRONEER-ILD trial.

Reference:

• A study to find out whether BI 1015550 improves lung function in people with idiopathic pulmonary fibrosis. https://clinicaltrials.gov/study/NCT05321069. Last updated Aug. 29, 2024. Accessed Sept. 16, 2024.