Simulated efficacy of nerandomilast on forced vital capacity decline in idiopathic pulmonary fibrosis and progressive pulmonary fibrosis across background antifibrotic therapies

Presented at the ASCPT 2026 Annual Meeting. An exposure-response model was developed to evaluate the effect of nerandomilast on forced vital capacity (FVC) in patients with idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF) , capturing both an initial “offset effect” and a long-term “disease-modifying effect” on the rate of FVC decline. The analysis confirmed a positive exposure-response relationship that is maintained regardless of the underlying diagnosis. Furthermore, simulations support using an 18 mg twice-daily dose to mitigate the reduced drug exposure associated with background pirfenidone use, ensuring a robust treatment response for patients on multi-drug regimens.

Simulated efficacy of nerandomilast on forced vital capacity decline in idiopathic pulmonary fibrosis and progressive pulmonary fibrosis across background antifibrotic therapies Samuel P. Callisto1, Kyle Baron1, Elias Clark1, Curtis Johnston1∗, Nikolas Onufrak2∗, Sonja Hartmann2∗, Steve Choy2 1Metrum Research Group, Boston, MA, U.S.A., 2Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT, U.S.A. ∗Affiliation during time of analysis Introduction.