MannKind Corporation, a company focused on the development and commercialization of inhaled therapeutic products and devices for patients with endocrine and orphan lung diseases, announced six-month results from its phase 3 INHALE-1 study of Afrezza (insulin human) Inhalation Powder in children and adolescents (aged 4-17 years of age). MannKind expects to submit a request for a supplemental new drug application (sNDA) meeting with the US Food and Drug Administration (FDA) in 1H 2025 to discuss the data and filing timeline.
The INHALE-1 study is a 26-week, open-label clinical trial that randomized 230 subjects to one of two groups: Afrezza or multiple daily injections (MDI) of rapid acting insulin analog (RAA) in combination with basal insulin. The primary endpoint was a non-inferior change in HbA1c levels after 26 weeks. A 26-week extension phase in which all remaining MDI patients switched to Afrezza is still ongoing.
An analysis of the full intent-to-treat population (ITT) found that the between-group difference in mean HbA1c change over 26 weeks exceeded the prespecified non-inferiority margin of 0.4% (0.435%), largely driven by the variability of a single patient who did not adhere to the study protocol. A modified ITT (mITT) analysis, which excluded this subject, did not exceed the predetermined threshold of 0.4% (0.370%), thereby establishing the non-inferiority of Afrezza to MDI, which was the primary endpoint of the study.
Over 26 weeks of treatment, no difference in lung function parameters were seen between the treatment groups. The Afrezza-treated patients had a mean FEV1 of 2.901 liters (99.6% of predicted) at baseline and 2.934 liters (96.6% of predicted) at 26 weeks. MDI-treated patients had corresponding mean FEV1 values of 2.948 liters (102.3% of predicted) and 2.957 liters (98% of predicted), respectively. Additional safety findings, including for hypoglycaemia, did not show any significant concerns or differences between the treatment groups.
“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, senior vice president, therapeutic area head, endocrine diseases for MannKind Corporation.
“It was exciting to partner with MannKind and help lead this study to potentially expand the use of inhaled insulin, which is currently used successfully by many adults with diabetes, to a population that hasn’t had a treatment option other than injectable insulin in the history of their care,” said Dr. Roy W. Beck, founder of the Jaeb Center for Health Research who provided oversight for INHALE-1. “The six-month results are clinically meaningful and show Afrezza as a potential future treatment option for a growing paediatric population living with type 1 and type 2 diabetes.”
Afrezza (insulin human) Inhalation Powder is a rapid-acting inhaled human insulin indicated to improve glycaemic control in adults with diabetes mellitus.
MannKind Corporation focuses on the development and commercialization of innovative inhaled therapeutic products and devices to address serious unmet medical needs for those living with endocrine and orphan lung diseases.
