MannKind (MNKD) said Monday that a phase 1 trial evaluating nintedanib dry powder inhaler, dubbed MNKD-201, met the study's primary objective as it was demonstrated to be safe and well-tolerated among patients with pulmonary fibrotic diseases, including idiopathic pulmonary fibrosis.
The study had 24 participants in a single-dose group and 16 in a multiple-dose group. The secondary study objective was to evaluate MNKD-201's pharmacokinetics, the company said.
Data showed that participants did not experience the common adverse events associated with oral nintedanib, such as gastrointestinal or neurological issues. There was also no study drug discontinuation, the company said.
Chief Executive Michael Castagna said that the company is looking to discuss these results and plans for the late-stage development of MNKD-201 in a meeting with the US Food and Drug Administration in H1 2025.
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