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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.