MannKind Corporation has filed a notice with the US Securities and Exchange Commission (SEC) stating that manufacturing of clinical trial supplies for its planned Phase 2/3 study of MNKD-101 clofazimine inhalation suspension in patients with nontuberculous mycobacteria (NTM) lung infections will be delayed up to 6 months due to a fire at the facility that was set to produce the inhalation suspension for use in the trial. MannKind said that it “is evaluating several mitigation strategies and will update the projected timing for this clinical study at a later date.”
In September 2022, the company reported positive safety and tolerability results from a Phase 1 trial of the inhalation suspension. MNKD-101 has been granted orphan drug and QIDP designations by the FDA for the treatment of NTM lung infections.
Read the MannKind Corporation filing.
