MannKind Announces First Patient Enrolled in INHALE-1 Study of Afrezza in Pediatric Population
MannKind Corporation recently announced the enrollment of the first pediatric patient in the INHALE-1 study. The multi-center study will evaluate the efficacy and safety of Afrezza (Technosphere Insulin) in combination with basal insulin versus multiple daily injections of insulin in children and adolescents aged 4-17 who are living with type 1 or type 2 diabetes.
“We are pleased to announce enrollment has begun for the INHALE-1 Phase 3 study, which is designed to assess the safety and efficacy of Afrezza in young people living with type 1 or type 2 diabetes,” said Dr. Kevin Kaiserman, Vice President, Medical Affairs and Safety of MannKind Corporation. “MannKind is pleased to sponsor this study with the goal of bringing Afrezza to a younger generation.”
INHALE-1 is a 26-week open-label, randomized clinical trial with a 26-week extension. The primary endpoint is change in HbA1c level after 26 weeks. Secondary endpoints include change in fasting plasma glucose after 26 weeks and rate of hypoglycemic events.
Enrollment is underway at several sites, including AM Diabetes & Endocrinology Center in Bartlett, Tenn., where the first patient was enrolled. In all, approximately 260 patients are planned to be enrolled at more than 30 sites across the United States. Details of the study and sites can be found at: https://clinicaltrials.gov/ct2/show/NCT04974528.
“We are glad to see the INHALE-1 study start enrolling pediatric patients and look forward to its expansion to more youth across the country,” said Dr. Michael J. Haller, Professor and Chief of Pediatric Endocrinology at the University of Florida and Chair for the INHALE-1 study. “Being involved with studies that can impact a large population of people living with T1D/T2D is so valuable, and I’m looking forward to seeing the data as MannKind continues to explore the potential of Afrezza for youth.”
MannKind Corporation focuses on the development and commercialization of inhaled therapeutic products for patients with endocrine and orphan lung diseases. MannKind is currently commercializing Afrezza (insulin human) Inhalation Powder, the company’s first FDA-approved product and the only inhaled ultra rapid-acting mealtime insulin in the US, where it is available by prescription from pharmacies nationwide. Afrezza is also available by prescription in Brazil, where it is commercialized by the company’s partner, Biomm SA. MannKind was established in 1991 and is headquartered in Westlake Village, CA, with a manufacturing and R&D facility based in Danbury, CT. The company also employs field sales and medical representatives across the US. For more information, visit mannkindcorp.com.
Total Page Views: 252