Boehringer Ingelheim Reports Topline Data from P-III (FIBRONEER-ILD) Study of Nerandomilast for Progressive Pulmonary Fibrosis (PPF)
Shots:
- BI reported topline data from P-III (FIBRONEER-ILD) study assessing nerandomilast (BI 1015550; 9/18mg, BID) vs PBO in PPF pts (n=1178) for ~52wks. with regulatory filings in the US & other regions underway
- Study met its 1EP of absolute change from baseline in forced vital capacity (FVC; mL) with favorable safety consistent with P-II; full data to be disclosed in Q2’25
- Nerandomilast is being studied in the FIBRONEER program, which incl. 2 P-III (FIBRONEER-IPF & FIBRONEER-ILD) trials for IPF & PPF, respectively, assessing the same 1EP (FVC) & composite 2EP (time to first acute IPF/ILD exacerbation, first respiratory hospitalization, or death over the period of trials)
Ref: Boehringer Ingelheim | Image: Boehringer Ingelheim
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