MannKind Prepares to Present Pediatric Inhaled Insulin Data at ADA Scientific Sessions
Key Insights
MannKind Corporation will showcase results from its Phase 3 INHALE-1 clinical trial of Afrezza inhaled insulin in children and adolescents aged 4-17 at the American Diabetes Association's 85th Scientific Sessions in Chicago.
Dr. Michael J. Haller from the University of Florida will present breakthrough pediatric Type 1 diabetes care data during a "Future Ready" symposium on June 22, 2025.
The company expects to release topline results from the full pediatric dataset in Q2 2025 and plans to submit a Supplemental Biologics License Application for pediatric indication by mid-2025.
MannKind Corporation will present pivotal data from its pediatric inhaled insulin program at the American Diabetes Association's 85th Scientific Sessions, taking place June 20-23 in Chicago. The company's Phase 3 INHALE-1 clinical trial results for Afrezza (insulin human) Inhalation Powder in children and adolescents aged 4-17 years will be featured prominently during the conference.
Key Presentations at ADA Scientific Sessions
Dr. Michael J. Haller, Professor and Chief of Pediatric Endocrinology at the University of Florida and Chair of MannKind's Phase 3 INHALE-1 study, will present results from the randomized period of the clinical trial during a "Future Ready" symposium focused on breakthrough pediatric Type 1 diabetes care. The presentation, titled "From Discovery to Treatment – Latest Updates on Inhaled Insulin Treatment," is scheduled for Sunday, June 22, from 1:30 to 3:00 p.m. Central in Room W 181(A-C).
Additional scientific presentations will include patient-reported outcomes data with inhaled Technosphere insulin and efficacy and safety results from a Phase III clinical trial conducted in India comparing Afrezza with placebo in adult individuals with Type 2 diabetes mellitus. Dr. Peter Calhoun will present the patient-reported outcomes data, while Dr. K M Prasanna Kumar will present the Indian Phase III trial results, both on Saturday, June 21, from 12:30 to 1:30 p.m. Central.
Regulatory Timeline and Commercial Strategy
MannKind expects to issue topline results from the full pediatric dataset with safety extension in the second quarter of 2025. The company anticipates submitting a Supplemental Biologics License Application in mid-2025 for a potential pediatric indication for Afrezza, marking a significant milestone in expanding treatment options for young patients with diabetes.
The company will maintain a presence at booth #1617 in the Exhibit Hall throughout the ADA Scientific Sessions, where members of MannKind's Medical Education Team will be available for scientific exchange in the medical section of the booth.
Technology Platform and Therapeutic Focus
MannKind Corporation focuses on developing and commercializing innovative inhaled therapeutic products and devices to address unmet medical needs for patients with endocrine and orphan lung diseases. The company's signature technologies include dry-powder formulations and inhalation devices that offer rapid and convenient delivery of medicines to the deep lung, where they can exert local effects or enter systemic circulation depending on the target indication.
Beyond diabetes, MannKind is committed to using its formulation capabilities and device engineering expertise to address diseases including nontuberculous mycobacterial lung disease, pulmonary fibrosis, and pulmonary hypertension.