MannKind(US:MNKD) Globenewswire·2026-02-09 11:05Core Viewpoint - MannKind Corporation has initiated the INHALE-1 clinical study to evaluate the safety and efficacy of Afrezza inhaled insulin in youth aged 10 to under 18 years recently diagnosed with type 1 diabetes, aiming to reduce the burden of insulin injections for pediatric patients and their families [1][2]. Group 1: Study Details - The INHALE-1 study will assess Afrezza used in combination with subcutaneously injected basal insulin once daily, focusing on clinical outcomes and participant satisfaction [2]. - The study will enroll approximately 100 patients across about 10 clinical sites in the United States, with the first patient enrolled at the Barbara Davis Center for Diabetes in Aurora, Colorado [3]. - Participants will be followed for 13 weeks during the main phase, with an optional extension phase for up to 26 weeks [4]. Group 2: Primary Endpoint and Objectives - The primary endpoint is the percentage of participants with a Continuous Glucose Meter (CGM) measuring time in range (TIR) of 70-180 mg/dL at least 70% during the 14 days prior to the 13-week visit [4]. - The study aims to evaluate whether replacing most insulin injections with inhalations can ease the adjustment to managing type 1 diabetes for children and their families [2]. Group 3: Regulatory Status - The FDA is currently reviewing a supplemental Biologics License Application (sBLA) for Afrezza in children and adolescents with type 1 or type 2 diabetes, with a target action date of May 29, 2026 [5]. - If approved, Afrezza would be the first needle-free insulin option for pediatric patients in over a century [5]. Group 4: Company Overview - MannKind Corporation is focused on transforming chronic disease care through innovative solutions, particularly in cardiometabolic and orphan lung diseases [9][10]. - The company aims to develop treatments that address serious unmet medical needs, including diabetes and related conditions [9].