MannKind Corporation has announced that data from a recently completed Phase 1 study of MNKD-201 nintedanib DPI support continued development of the inhaler for the treatment of idiopathic pulmonary fibrosis (IPF). MannKind had announced plans for the Phase 1 SAD/MAD study earlier this year. The announcement includes highlights of safety results and does not present any PK data, stating that evaluating PK was a secondary study objective.
The Phase 1 study enrolled 40 healthy adults between ages 40 and 65. According to MannKind, no serious adverse events were reported, and no adverse events associated with oral nintedanib were reported. The company said that reported events of cough and drop in FEV1 were “mild, transient, and fully recovered.”
MannKind CEO Michael Castagna commented, “These compelling results support advancing the development of nintedanib DPI for patients living with IPF, a chronic and progressive fibrotic lung disease with limited treatment options. We look forward to discussing the Phase 1 trial results and our proposed late-stage development program at an end of Phase 1 meeting with the FDA, planned for the first half of 2025.”
Senior VP, Therapeutic Area Head, Orphan Lung Diseases, Wassim Fares added, “We are encouraged by the findings from this Phase 1 study of nintedanib DPI. Building on the known efficacy of oral nintedanib for IPF, delivery of a dry powder formulation directly to the lungs could potentially treat the disease while reducing the common adverse effects associated with oral delivery of nintedanib. Pending late-stage development trials, nintedanib DPI could offer an alternative and/or addition to current IPF therapies.”
Read the MannKind Corporation press release.
