MannKind Corporation announced the initiation of the Phase 2 INFLO-2 trial of its MNKD-201 nintedanib DPI in patients with idiopathic pulmonary fibrosis. The 12-week INFLO-2 study is expected to enroll approximately 210 IPF patients who will receive either a 2 mg dose of MNKD-201 4 times daily or a 4 mg dose twice daily or placebo. A 24-week open-label extension will follow.
The company also said that it expects to report data from the ongoing Phase 1b INFLO-1 study of the nintedanib DPI in patients with IPF later this year. In late 2024, MannKind reported that results from a Phase 1 trial in healthy adults supported further development of MNKD-201.
MannKind Senior VP, Therapeutic Area Head, Respiratory, Wassim Fares commented, “We are encouraged by the emerging data from our Phase 1b study, which continues to support our hypothesis around the safety and tolerability of inhaled nintedanib DPI. These findings reinforce the potential of nintedanib DPI as a simple and convenient administration to efficiently deliver therapy directly to the lungs, with potential to maintain antifibrotic effect and improve tolerability and long-term adherence. It may also facilitate the opportunity for use in combination with current and future IPF therapies.”
CEO Michael Castagna said, “Advancing into this next stage of development represents an important inflection point for our nintedanib DPI program. With Phase 1b data expected in Q3 2026 and a global Phase 2 study now underway, we believe we are well-positioned to generate early clinical validation of our inhaled approach and to further define its potential in IPF.”
In addition to progressing the nintedanib DPI, MannKind recently said that it would develop a DPI formulation of MNKD-1501 ralinepag for the treatment of PAH for United Therapeutics, and the FDA approved use of the company’s Afrezza inhaled dry powder insulin in children aged 6 and over.
Read the MannKind Corporation press release
