¹Department of Internal Medicine, Rheumatology, Pulmonology, Nephrology & Diabetology, Medius Kliniken, University of Tübingen, Kirchheim-unter-Teck
²Department of Pulmonary, Critical Care and Sleep Medicine, Keck School of Medicine, University of Southern California; Section of Inflammation, Repair and Development, National Heart and Lung Institute, Imperial College London, London, UK, Los Angeles, California
³Division of Rheumatology, McGovern Medical School, University of Texas, Houston, TX
⁴Clinical Research Center, Mihara General Hospital, Saitama, Japan; Nippon Medical School, Tokyo
⁵National Reference Center for Rare Pulmonary Diseases, Louis Pradel Hospital, Hospices Civils de Lyon, Claude Bernard University Lyon 1, UMR 754, ERN-LUNG, Lyon
⁶Department of Rheumatology, Oslo University Hospital, Oslo, Norway; Department of Rheumatology, University Hospital Zurich, University of Zurich, Zurich
⁷Mainz Center for Pulmonary Medicine, Department of Pneumology, Mainz University Medical Center and Department of Pulmonary, Critical Care & Sleep Medicine, Marienhaus Clinic Mainz, Mainz
⁸Pulmonary and Critical Care Medicine, University of Michigan, Ann Arbor, Michigan
⁹Unità Operativa Complessa di Pneumologia, Fondazione Policlinico Universitario A. Gemelli IRCCS, Università Cattolica del Sacro Cuore, Rome
¹⁰Pulmonology Department, Hospital Universitario de la Princesa, Universidad Autónoma de Madrid, Madrid
¹¹Center of Expertise for Interstitial Lung Diseases, Department of Respiratory Medicine, Erasmus MC, University Medical Centre, Rotterdam
¹²Therapy Area Inflammation Medicine, Boehringer Ingelheim International GmbH, Ingelheim am Rhein
¹³Boehringer Ingelheim SComm, Brussels
¹⁴Global Biostatistics and Data Sciences, Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT
¹⁵Boehringer Ingelheim bv, Amsterdam
¹⁶Global Biostatistics and Data Sciences, Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim am Rhein
¹⁷Global Clinical Development and Medical Affairs, Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, Connecticut

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Background: There is a need for more effective treatments for progressive pulmonary fibrosis (PPF). Nerandomilast, an oral preferential inhibitor of PDE4B was evaluated in doses of 9 mg bid or 18 mg bid in a randomised (1:1:1), double-blind, Placebo-controlled Phase III trial in PPF.

Aims: To report the primary results of the FIBRONEER-ILD trial.

Methods: Patients with pulmonary fibrosis other than idiopathic pulmonary fibrosis that met criteria for progression were randomised to nerandomilast 9 mg, 18 mg, or placebo twice daily. Randomisation is stratified by HRCT pattern (usual interstitial pneumonia-like vs other fibrotic patterns) and presence of background AF treatment. Baseline characteristics were collected prior to randomisation. The primary endpoint is absolute change from baseline in FVC (mL) at Week 52.

Results: 1,780 patients were screened, with 1,178 randomised and 1,176 treated (Figure 1 [Fig. 1]). Median FVC and DLco at baseline were 69% predicted and 47% predicted, respectively. Topline data from FIBRONEER™-ILD show that the investigational compound nerandomilast met its primary endpoint. Final results of the primary efficacy analysis and safety will be presented at the conference (currently under journal embargo).

Conclusions: This trial will provide insights into the efficacy and safety of nerandomilast in patients with PPF.

The following disclosures could not be entered in the submission tool and will therefore only be displayed on the final encore poster:

This trial was supported and funded by Boehringer Ingelheim. The authors meet criteria for authorship as recommended by the International Committee of Medical Journal Editors (ICMJE). The authors did not receive payment for the development of the abstract.