Inhaled Insulin for Pediatric Patients Shows Positive Results in Phase 3 Trial

Positive results have been announced from a phase 3 trial evaluating the efficacy and safety of insulin human (Afrezza) inhaled powder for the treatment of diabetes in pediatric patients aged 4 to 17 years, biopharmaceutical company Mannkind said in a release.¹ Based on the positive data, Mannkind said it plans to meet with the FDA in the first half of 2025 to discuss the filing timeline of a supplemental new drug application (sNDA).

Inhaled Insulin for Pediatric Patients Shows Positive Results in Phase 3 Trial / Minerva Studio - stock.adobe.com

Results from the INHALE-1 (NCT04974528) trial showed that insulin human inhaled powder met its primary endpoint of non-inferiority to multiple daily injections of rapid acting insulin analog as measured by change in HbA1c from baseline to week 26. The therapy also showed that there were no significant safety concerns when compared to multiple daily injections of rapid acting insulin analog.

READ MORE: Wearing CGMs Can Help Student Pharmacists Improve Counseling Ability

“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,” Roy W. Beck, who provided oversight for the INHALE-1 study, said in a release.¹ “The 6-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.”

INHALE-1 is an open-label, randomized clinical study evaluating the efficacy and safety of insulin human inhaled powder in combination with a basal insulin compared to insulin aspart, insulin lispro or insulin glulisine in combination with a basal insulin in pediatric patients with type 1 or type 2 diabetes. The study cohort included 230 patients aged between 4 and 18 years who were followed for 26 weeks.

The study found that that the between-group difference in mean HbA1c change exceeded the prespecified non-inferiority margin of 0.4%. However, during a modified analysis were a patient was removed due to non-adherence, the prespecified non-inferiority margin was not exceeded, showing that insulin human inhaled powder was non-inferior to multiple daily injections of rapid acting insulin analog.

Over the study period, there was no difference in lung function parameters between the 2 groups. The study also showed that there was no significant safety concerns or differences between the groups for other measures, including hypoglycemia.

“The overall efficacy and safety outcomes seen in the first 26 weeks are encouraging,” Kevin Kaiserman, senior vice president and therapeutic area head of endocrine diseases at MannKind, said in a release.¹ “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.”

Insulin human inhaled powder was initially approved by the FDA in 2014 to improve glycemic control in adult patients with diabetes. Mannkind is currently conducting a 26-week extension phase of INHALE-1, in which all remaining patients receiving multiple daily injections of rapid acting insulin analog were switched to insulin human inhaled powder. The study is assessing the safety and efficacy of continued use of insulin human inhaled powder.

READ MORE: Diabetes Resource Center

Are you ready to elevate your pharmacy practice? Sign up today for our free Drug Topics newsletter and get the latest drug information, industry trends, and patient care tips, straight to your inbox.

References

1. MannKind Announces Six-Month Results From Phase 3 INHALE-1 Pediatric Diabetes Trial Utilizing Inhaled Insulin (Afrezza). News Release. Mannkind. December 16, 2024. Accessed December 18, 2024. https://investors.mannkindcorp.com/news-releases/news-release-details/mannkind-announces-six-month-results-phase-3-inhale-1-pediatric