INHALE-1 looked at Afrezza in children and adolescents between 4-17 years of age. The company expects the data to support an upcoming request for a supplemental new drug application (sNDA) meeting with the FDA. It aims to set that up for the first half of 2025 with the hopes of discussing the data and filing timeline.
The 26-week, open-label clinical trial randomized 230 subjects to either Afrezza or multiple daily injections (MDI). The MDI group received rapid-acting insulin analog (RAA) in combination with basal insulin. INHALE-1 had a primary endpoint of non-inferior change in HbA1c levels after 26 weeks. The company also has an ongoing 26-week extension phase in which all remaining MDI patients switched to Afrezza.
A look at the study results from MannKind
An analysis found that the between-group difference in mean HbA1c change over 26 weeks exceeded the prespecified non-inferiority margin of 0.4% (0.435%). The company attributed this to the variability of a single patient who did not adhere to the study protocol. A modified analysis excluding that subject came in below the threshold (0.370%), establishing the non-inferiority of Afrezza.
Over 26 weeks, investigators saw no difference in lung function parameters, MannKind said. Additional safety findings, including for hypoglycemia, revealed no significant concerns or differences between treatment groups.
Dr. Roy W. Beck provided oversight for the study. Beck said the results “show Afrezza as a potential future treatment option for a growing pediatric population living with type 1 and type 2 diabetes.”
“The overall efficacy and safety outcomes seen in the first 26 weeks are encouraging. This represents a monumental step in our more than 25-year history of pioneering the development of inhaled insulin and working to bring this new treatment option to children and adolescents over the past seven years,” said Dr. Kevin Kaiserman, SVP, therapeutic area head, endocrine diseases for MannKind Corporation.
