Boehringer’s nerandomilast meets primary endpoint in pivotal phase-III FIBRONEER™-IPF study
- Topline data from FIBRONEER™-IPF show that the investigational compound nerandomilast met its primary endpoint, which was the absolute change from baseline in Forced Vital Capacity [mL] at week 52 versus placebo.
- The FIBRONEER™-IPF trial is the largest trial in idiopathic pulmonary fibrosis (IPF) conducted to date. Patients were recruited in over 330 sites and in over 30 countries.1,5
- Full efficacy and safety data from the trial will be presented in the first half of 2025.
- Boehringer Ingelheim will submit a new drug application for nerandomilast for the treatment of IPF to the US FDA and other Health Authorities worldwide.
Ingelheim, Germany, Mon, 16/09/2024 – 12:00
Boehringer Ingelheim announced today that the FIBRONEER™-IPF trial met its primary endpoint, which was the absolute change from baseline in Forced Vital Capacity [mL] (FVC) at week 52 versus placebo. FVC is a measure of lung function.1
Based on these results, Boehringer Ingelheim will submit the new drug application for nerandomilast for the treatment of IPF to the US Food & Drug Administration (FDA) and other Health Authorities worldwide. The FDA granted Breakthrough Therapy Designation in IPF in 2022.2
“This is the first IPF phase-III-trial in a decade to meet its primary endpoint9,” said Ioannis Sapountzis, Head of Global Therapeutic Areas at Boehringer Ingelheim. “Today’s announcement represents the next step in our long history in the research of 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.”
Nerandomilast is an oral, investigational phosphodiesterase 4B (PDE4B) inhibitor and has not been approved for use, therefore safety and efficacy have not been established.3 It is being investigated as part of the FIBRONEER™ global program, which includes two Phase III studies —FIBRONEER™-IPF4 in patients with IPF and FIBRONEER™-ILD5 in people living with Progressive Pulmonary Fibrosis (PPF).
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