MannKind Corporation has announced the initiation of the Phase 2 INHALE-1ST trial of Afrezza inhaled dry powder insulin in children aged 10 and over who have recently received a diagnosis of Type 1 diabetes. The study is expected to enroll approximately 100 patients and will evaluate patient and caregiver satisfaction in addition to safety and efficacy.
The FDA is currently reviewing MannKind’s sBLA for the use of Afrezza inhaled dry powder insulin in Type 1 and Type 2 diabetes patients aged 4 to 17. That application includes data from the Phase 3 INHALE-1 trial of Afrezza in pediatric patients. MannKind reported results from that study in December 2024. Afrezza has been approved in the US for the treatment of Type 1 and Type 2 diabetes in adults since 2014.
MannKind CEO Michael Castagna commented, “Many of the innovations that transformed diabetes care such as continuous glucose monitors (CGMs) and insulin pumps proved their full value and impact once they became available to pediatric patients. With nearly a decade of safety and real-world adult experience behind Afrezza, INHALE-1ST gives us an important opportunity to assess use earlier in the treatment journey for youth at the time of diagnosis so patients can potentially improve management of their mealtime glucose.”
Read the MannKind Corporation press release
