Core Insights - MannKind Corporation has successfully enrolled 305 patients with type 1 or type 2 diabetes in its INHALE-1 study, which focuses on the efficacy and safety of inhaled insulin in the pediatric population [1][2] - The primary endpoint analysis is anticipated to be completed in the fourth quarter of 2024, with data dissemination and FDA submission expected in 2025 [1][3] Company Overview - MannKind Corporation specializes in the development and commercialization of innovative therapeutic products for endocrine and orphan lung diseases, utilizing dry-powder formulations and inhalation devices for effective drug delivery [4] - The company aims to address serious unmet medical needs, particularly in diabetes management, pulmonary arterial hypertension, and nontuberculous mycobacterial lung disease [4] Study Details - The INHALE-1 study is a 26-week open-label, randomized clinical trial with a 26-week extension, focusing on the change in HbA1c levels as the primary endpoint [2] - Secondary endpoints include changes in fasting plasma glucose and the rate of hypoglycemic events, comparing Afrezza in combination with basal insulin against multiple daily injections of insulin in children and adolescents aged 4-17 [2]
MannKind Announces Enrollment Goal Completion of INHALE-1 Pediatric Diabetes Trial Utilizing Afrezza®