Nerandomilast in Patients with Progressive Pulmonary Fibrosis

Area of Science:

• Pulmonology
• Pharmacology

Background:

• Nerandomilast is an oral phosphodiesterase 4B inhibitor with antifibrotic and immunomodulatory effects.
• Previous studies showed efficacy in idiopathic pulmonary fibrosis; its effect on other progressive pulmonary fibrosis types requires investigation.

Purpose of the Study:

• To assess the efficacy and safety of nerandomilast in patients with progressive pulmonary fibrosis.

Main Methods:

• Phase 3, double-blind trial involving 1176 patients with progressive pulmonary fibrosis.
• Patients received nerandomilast (18 mg or 9 mg twice daily) or placebo.
• Primary endpoint: absolute change in forced vital capacity (FVC) from baseline at 52 weeks.

Main Results:

• Nerandomilast 18 mg and 9 mg groups showed a smaller FVC decline (-98.6 ml and -84.6 ml) compared to placebo (-165.8 ml) at 52 weeks.
• The differences were statistically significant (P<0.001) for both nerandomilast doses versus placebo.
• Diarrhea was the most common adverse event; serious adverse events were similar across groups.

Conclusions:

• Nerandomilast treatment resulted in a significantly smaller decline in FVC compared to placebo in patients with progressive pulmonary fibrosis over 52 weeks.
• Nerandomilast demonstrates potential as a treatment for progressive pulmonary fibrosis.