Nerandomilast Meets Primary Endpoint in Phase III FIBRONEER-ILD Trial in Progressive Pulmonary Fibrosis

Boehringer Ingelheim announced topline data from the company's phase III FIBRONEER-ILD, which met its primary endpoint, demonstrating a statistically significant absolute change from baseline in forced vital capacity (FVC) at week 52 versus placebo. Nerandomilast, an investigational oral preferential phosphodiesterase 4B (PDE4B) inhibitor, is being studied as a potential treatment for progressive pulmonary fibrosis (PPF). The drug was previously granted FDA Breakthrough Therapy Designation for treatment of interstitial PF in February 2022, Boehringer Ingelheim said in the February 10 news release.

Initial safety and tolerability results from the FIBRONEER trials were generally consistent with phase II data in idiopathic pulmonary fibrosis (IPF), according to the news release. Adverse events were comparable between the nerandomilast and placebo groups. Full efficacy and safety data from FIBRONEER-ILD, the second phase III trial in which the investigational compound has met its primary endpoint, are expected in the second quarter of 2025, according to a news release from the company.

The FIBRONEER program includes 2 phase III studies: FIBRONEER-IPF and FIBRONEER-ILD, both designed to evaluate the efficacy, safety, and tolerability of nerandomilast over at least 52 weeks. The primary endpoint in both trials is the absolute change in FVC from baseline at 52 weeks. A key secondary endpoint is time to first occurrence of any of the components of the composite endpoint: acute exacerbation, first hospitalization for a respiratory cause, or death.

In FIBRONEER-ILD, 1,178 patients with PPF were enrolled across more than 400 locations in more than 40 countries. Patients received oral nerandomilast 9 mg or 18 mg twice daily, or placebo. The higher 18 mg dose was supported by phase II results, while the lower 9 mg dose was included to further evaluate the benefit-risk profile and dose-response relationship.

Based on these phase III results, Boehringer Ingelheim plans to submit a new drug application for nerandomilast for the treatment of PPF to the FDA and other regulatory authorities worldwide.

“The positive FIBRONEER™-ILD topline result shows the potential of nerandomilast in progressive pulmonary fibrosis. 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 the press announcement.

The FIBRONEER-ILD results come five months after a separate Phase III trial of nerandomilast in patients with IPF (NCT05321069), called the FIBRONEER-IPF, also met its primary endpoint of FVC change at 52 weeks. Boehringer Ingelheim has already submitted a separate NDA to the FDA and other agencies for approval of nerandomilast in IPF.

IPF is one of the more common progressive fibrosing interstitial lung diseases, affecting approximately 3 million people globally. PPF can develop in non-IPF fibrosing ILDs and is characterized by worsening respiratory symptoms, physiological disease progression, and radiologic evidence of fibrosis. The disease can lead to irreversible lung damage and early mortality.

Boehringer’s nerandomilast meets primary endpoint in Phase III study FIBRONEER™-ILD, in progressive pulmonary fibrosis