Boehringer's Nerandomilast Meets Primary Endpoint In Pivotal Phase-III FIBRONEERTM-IPF Study
Date
9/23/2024 1:20:36 AM
(MENAFN- Mid-East Info) Boehringer Ingelheim announced today that the FIBRONEERTM-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
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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 FIBRONEERTM global program, which includes two Phase III studies -FIBRONEERTM-IPF4 in patients with IPF and FIBRONEERTM-ILD5 in people living with Progressive Pulmonary Fibrosis (PPF).
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