MannKind Reports Six-Month Phase 3 INHALE-1 Trial Results for Pediatric Diabetes Using Inhaled Insulin

MannKind Corporation, listed on Nasdaq as MNKD, has released promising six-month results from its Phase 3 INHALE-1 clinical trial. This study investigates the use of Afrezza, an inhaled insulin powder, in a younger demographic of children and adolescents aged 4 to 17. The company is planning to have a meeting with the U.S. Food and Drug Administration (FDA) in the first half of 2025 to propose a supplemental new drug application (sNDA) based on these findings.

The INHALE-1 trial is a comprehensive 26-week, open-label study that enrolled 230 participants. These individuals were randomly assigned to either the Afrezza treatment group or a control group using multiple daily injections (MDI) of rapid-acting insulin analogs alongside basal insulin. The main goal was to demonstrate that Afrezza is not inferior to the existing treatment in terms of changes in HbA1c levels over the 26-week period. There is also an ongoing extension phase where all participants initially on MDI are transitioned to Afrezza.

In the full intent-to-treat (ITT) population, the difference in average HbA1c change between the two groups exceeded the predefined non-inferiority margin of 0.4%. This was largely due to a single participant whose protocol deviation affected the results. When this individual was excluded in a modified ITT (mITT) analysis, the difference fell below the threshold (0.370%), affirming that Afrezza is indeed non-inferior to traditional MDI treatment.

Lung function, a critical safety parameter, showed no variation between the two groups over the 26 weeks. Afrezza users started with a mean Forced Expiratory Volume (FEV1) of 2.901 liters at baseline, which slightly increased to 2.934 liters. Meanwhile, the MDI group began with 2.948 liters and experienced a modest rise to 2.957 liters. No notable safety concerns, including hypoglycemia, emerged, indicating that Afrezza is comparable to traditional methods in terms of safety.

Dr. Kevin Kaiserman, MannKind Corporation’s Senior Vice President and Therapeutic Area Head for Endocrine Diseases, expressed optimism about these preliminary results. He highlighted the study as a pivotal moment in MannKind’s ongoing efforts over the past two decades to develop inhaled insulin therapies, aiming to provide a new option for pediatric diabetes management.

Dr. Roy W. Beck, from the Jaeb Center for Health Research, which oversaw the study, emphasized the potential expansion of inhaled insulin use to younger patients who have historically relied on injections. He noted that the six-month findings are clinically significant, positioning Afrezza as a future treatment for the increasing number of children with type 1 and type 2 diabetes.

Afrezza is already recognized as a rapid-acting inhaled insulin for adult diabetes management. MannKind Corporation specializes in designing and commercializing breakthrough inhaled therapy solutions for complex endocrine and rare lung conditions. They leverage their expertise in dry-powder formulations and inhalation device technology to deliver medications effectively to the lungs, providing therapeutic action either locally or systemically.

The corporation’s mission is driven by a dedicated team working across the country to empower individuals to manage their health independently and lead fulfilling lives.