MannKind Corporation's Afrezza, an inhaled insulin, has shown promising results in a Phase 3 clinical trial for pediatric patients with diabetes. The INHALE-1 study, a 26-week trial involving 230 children and adolescents aged 4-17, compared Afrezza to multiple daily injections (MDI) of rapid-acting insulin. The trial met its primary endpoint, demonstrating that Afrezza was non-inferior to MDI in terms of HbA1c change.
Key Findings of the INHALE-1 Trial
The modified intent-to-treat (mITT) analysis, which excluded one non-adherent patient, revealed a between-group difference of 0.370% in HbA1c change. This result met the pre-specified non-inferiority margin of 0.4%, indicating that Afrezza is an effective alternative to traditional insulin injections for managing blood sugar levels in young patients. The full intent-to-treat population (ITT) analysis showed a 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.
Safety and Lung Function
Importantly, the study found no significant differences in lung function or safety parameters between the two treatment groups. Afrezza-treated patients maintained stable FEV1 values, averaging between 96-99% of predicted levels. There were also no significant concerns regarding hypoglycemia or other adverse events.
Expert Commentary
"The overall efficacy and safety outcomes seen in the first 26 weeks are encouraging," said Dr. Kevin Kaiserman, Senior Vice President, Therapeutic Area Head, Endocrine Diseases for MannKind Corporation. "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."
Dr. Roy W. Beck, founder of the Jaeb Center for Health Research, who provided oversight for INHALE-1, added, "The six-month results are clinically meaningful and show Afrezza as a potential future treatment option for a growing pediatric population living with type 1 and type 2 diabetes."
Next Steps for MannKind
With these positive results in hand, MannKind plans to meet with the FDA in the first half of 2025 to discuss a potential supplemental new drug application (sNDA) submission. If approved, this could significantly expand Afrezza's market to include the pediatric population, offering a needle-free alternative for insulin delivery.
Implications for Pediatric Diabetes Treatment
The findings from the INHALE-1 trial offer hope for children and adolescents with diabetes, who often struggle with the burden of multiple daily injections. An inhaled insulin option could improve adherence and quality of life for these young patients. The prevalence of diabetes in younger populations is rising, and there is a clear unmet need for needle-free insulin delivery options.
