Nerandomilast primary endpoint phase-3 FIBRONEER-IPF met
WEBSep 16, 2024 · 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 ...
FIBRONEER-IPF Trial of Nerandomilast Meets Primary End Point
WEB4 days ago · They were divided into 3 groups, taking a dose of nerandomilast 9 mg, nerandomilast 18 mg, or placebo twice daily. The primary end point was absolute change in FVC—a key measure of lung function ...
Positive topline data reported in phase 3 trial of nerandomilast in ...
WEB6 days ago · 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 ...
Boehringer seeks approval for lung fibrosis drug following Phase …
WEBSep 16, 2024 · The Phase III FIBRONEER-IPF trial enrolled 1,177 patients with IPF randomised to receive either nerandomilast or placebo twice daily. The study’s secondary endpoint is time to the first occurrence of acute IPF exacerbation, first hospitalisation for respiratory cause, or death.
Nerandomilast Shows Promise in Idiopathic Pulmonary Fibrosis Trial
WEB6 days ago · IPF is a rare progressive fibrosing interstitial lung disease with symptoms that include breathing difficulty, dry and persistent cough, chest discomfort and fatigue. The randomized, double-blind, placebo-controlled FIBRONEER-IPF trial (ClinicalTrials.gov Identifier: NCT05321069) enrolled 1177 patients aged 40 years and older with IPF.
Boehringer’s nerandomilast Phase III win sets stage for FDA filing
WEBSep 16, 2024 · Based on these results, Boehringer said it will submit the new drug application (NDA) for nerandomilast for the treatment of IPF to the US Food and Drug Administration (FDA) and other health authorities worldwide. The FDA granted Breakthrough Therapy designation for the drug in IPF in 2022. ... All the news that moves the needle in pharma and ...
Trial sets up filings for Boehringer IPF drug nerandomilast
WEB6 days ago · Nerandomilast (BI 1015550) has been highlighted for some time as Boehringer's best chance to defend its IPF business in the coming years. Ofev contributed €3.5 billion of the company's total ...
Boehringer’s nerandomilast meets primary endpoint in ... - BioSpace
WEBSep 16, 2024 · About nerandomilast. Nerandomilast (BI 1015550) is an investigational oral, preferential inhibitor of phosphodiesterase 4B (PDE4B) that is being studied as a potential treatment for idiopathic pulmonary fibrosis ... BioSpace is the digital hub for life science news and jobs. We provide essential insights, opportunities and tools to connect ...
Boehringer’s nerandomilast meets primary ... - Boehringer …
WEBTopline data from FIBRONEER TM-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 TM-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
Boehringer's phase 3 lung fibrosis trial hits primary endpoint
WEBSep 16, 2024 · Boehringer tried to end the losing streak by moving its PDE4B inhibitor nerandomilast into a phase 3 program in 2022. Patients on nerandomilast performed better on the forced vital capacity...