MKC-NI-002 is a Phase 1b, randomized, double-blind, placebo-controlled study of nintedanib inhalation powder (MNKD-201) in patients with Idiopathic Pulmonary Fibrosis (IPF). The trial consists of Multiple Ascending Doses (MAD) with the primary objective to evaluate safety, tolerability and pharmacokinetics (PK) of MNKD-201 compared to placebo in patients with IPF.
Phase 1 trials primarily test safety and dosing in a small number of participants (typically 20–100). Results do not yet speak to efficacy. FDA approval is typically many years away from this stage.
This trial has completed. Results may be available via ClinicalTrials.gov or peer-reviewed publications.
MannKind Corporation (MNKD) is the sponsoring company for this trial. BiotechSign currently grades this company D (35/100) based on composite catalyst signals across its full pipeline. This trial is one data point in that overall catalyst picture.