2025 American Cough Conference

Background: There is a significant unmet medical need for a safe, effective and well-tolerated treatment of chronic cough in patients with idiopathic pulmonary fibrosis (IPF).Preclinical and preliminary clinical results suggest that ME-015 (suplatast tosilate), an oral immunomodulator with presumed effects on nicotinic Acetylcholine receptor currents at the paratracheal ganglion, could be effective in treating fibrotic cough in IPF.Methods: COSMIC-IPF is a Phase 2a, placebo-controlled, randomized controlled trial conducted as a multi-centre study in about 40 patients with externally adjudicated diagnosis of IPF and objectively measured of cough frequency using the VitaloJak device.After a single-blinded placebo run-in phase, patients are randomized to one of two treatment arms with a sequential design of 2 weeks of blinded treatment with oral ME-015 followed by 2 weeks of blinded treatment with placebo or vice versa, interspersed by a 2-week blinded placebo wash-out period. Results:The study has been fully recruited within the targeted timelines and the last patient last visit is expected in June 2025.Preliminary blinded safety and baseline cough results measured by VitaloJak are presented.The screen failure rate of 35% was mainly due to non-confirmation of IPF by external high-resolution CT (HRCT) review.To date, 4 out of 40 randomized patients have withdrawn from the study (none for safety or tolerability reasons).Adverse events were mostly mild and not related to treatment.One death occurred due to progression of the underlying disease and was judged unrelated to study treatment by Investigator and Sponsor.Baseline waking time cough counts are shown.Conclusions: With topline results expected early in the third quarter of 2025, these preliminary blinded results suggest that ME-015 is safe and well tolerated in patients with idiopathic pulmonary fibrosis and chronic cough.Clinical trial registry: NCT05983471; https:// clini caltr ials.gov.