MannKind Corporation announced that the Phase 1b INFLO-1 safety and tolerability trial of its nintedanib dry powder inhaler met its primary endpoint, demonstrating safety and tolerability. The multiple ascending dose study enrolled 27 patients with idiopathic pulmonary fibrosis. The company recently announced the initiation of the Phase 2 INFLO-2 trial, which is expected to enroll approximately 210 IPF patients.
According to MannKind, no serious adverse events were reported; no gastrointestinal side effects were reported; and no subjects discontinued treatment. The announcement says that “reported cough events were predominantly mild, transient and resolved” and notes that 60% of patients experienced no cough, with another 30% experiencing mild cough.
MannKind CEO Michael Castagna commented, “The INFLO-1 results represent an important milestone for our nintedanib DPI program and further validates the potential of our Technosphere platform in pulmonary fibrosis. Across our Phase 1a and Phase 1b studies, participants have received more than 700 inhalations of nintedanib DPI, including nearly 450 inhalations administered to people living with IPF. Importantly, cough was not a meaningful barrier to treatment. When observed, cough events were generally mild, transient and resolved, with no cough-related discontinuations or dose reductions. These findings provide growing confidence as we continue to advance Phase 2 development.”
Read the MannKind press release
