DANBURY, Conn. and WESTLAKE VILLAGE, Calif. — MannKind Corporation (Nasdaq: MNKD), a company focused on the development and commercialization of inhaled therapeutic products for patients with endocrine and orphan lung diseases, announced today that it has fully enrolled 305 patients living with type 1 or type 2 diabetes in its INHALE-1 study assessing efficacy and safety of inhaled insulin in the pediatric population.
As reported by pediatric study investigator Lori Laffel, MD, MPH, “There remains a need for innovative insulin preparations to help manage glucose levels at mealtimes in children and adolescents living with diabetes.” Dr. Laffel is Chief of the Pediatric, Adolescent and Young Adult Section at Joslin Diabetes Center and Professor of Pediatrics at Harvard Medical School. Dr. Laffel goes on to note that “It is especially important that young people have as many treatment options as their adult counterparts with diabetes, and this trial has the potential to expand the treatment choices for children and adolescents living with diabetes.”
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. The multi-center study evaluated Afrezza in combination with basal insulin vs. multiple daily injections (MDI) of insulin in children and adolescents aged 4-17 who are living with type 1 or type 2 diabetes.
“We are excited to reach this milestone in exploring the potential of Afrezza for a younger generation living with diabetes,” said Dr. Kevin Kaiserman, Senior Vice President, Clinical Development and Medical Affairs for MannKind Corporation. “We expect to complete a primary endpoint analysis in the fourth quarter.”
About MannKind
MannKind Corporation (Nasdaq: MNKD) focuses on the development and commercialization of innovative therapeutic products and devices to address serious unmet medical needs for those living with endocrine and orphan lung diseases.
We are committed to using our formulation capabilities and device engineering prowess to lessen the burden of diseases such as diabetes, pulmonary arterial hypertension (PAH) and nontuberculous mycobacterial (NTM) lung disease. Our signature technologies – dry-powder formulations and inhalation devices – offer rapid and convenient delivery of medicines to the deep lung where they can exert an effect locally or enter the systemic circulation.
With a passionate team of Mannitarians collaborating nationwide, we are on a mission to give people control of their health and the freedom to live life.
Contacts
For MannKind
Christie Iacangelo, Corporate Communications
(818) 292-3500
Email: [email protected]
Rose Alinaya, Investor Relations
(818) 661-5000
Email: [email protected]