Pulmonary function test results (PFTs) in patients treated with Afrezza (insulin human [rDNA origin]) Inhalation Powder, a well-tolerated, ultra rapid acting insulin, at follow-up measurements were similar to PFT results observed in patients receiving standard anti-diabetic therapy, according to data presented at the American Association of Clinical Endocrinologists 19th Annual Meeting. Results from the follow-up study suggest that the pattern and magnitude of changes in lung function associated with the use of Afrezza in patients with Type 1 and Type 2 diabetes are not likely due to any structural alterations in the lungs and are not clinically meaningful.

"Our findings add to the growing body of clinical evidence that indicates Afrezza is comparable to standard of care insulin therapy in terms of lung safety," said Peter Richardson, MRCP, corporate vice president and chief scientific officer, MannKind Corporation. "We are encouraged by these PFT data, which support our belief that Afrezza, clinically shown to provide glycemic control similar to standard therapy with less risk of hypoglycaemia and weight gain, is a promising new option that may address a poorly-met need in diabetes treatment."

Diabetes, which affects 26.8 million people in the US, is characterized by the body's inability to properly regulate levels of blood glucose, or blood sugar. Insulin, a hormone produced by the pancreas, normally regulates the body's glucose levels, but in people with diabetes insufficient levels of insulin are produced (Type 1 diabetes) or the body fails to respond adequately to the insulin it produces (Type 2 diabetes). Historically, mealtime insulin therapy regimens have had a number of limitations, including the risk of severe hypoglycaemia, the likelihood of weight gain, inadequate post-meal glucose control, the need for complex titration of insulin doses in connection with meals and the need for injections. Additionally, therapies have not mimicked the natural time-action profile of insulin normally seen in healthy individuals and presented challenges in maintaining compliance.

Afrezza is a novel, ultra rapid acting mealtime insulin therapy being developed by MannKind Corporation for the treatment of adult patients with Type 1 and Type 2 diabetes for the control of hyperglycaemia. It is a drug-device combination product, consisting of Afrezza Inhalation Powder pre-metered into single use dose cartridges and the light, discreet and easy-to-use Afrezza Inhaler. Administered at the start of a meal, Afrezza dissolves immediately upon inhalation and delivers insulin quickly to the blood stream. Peak insulin levels are achieved within 12 to 14 minutes of administration, mimicking the release of meal-time insulin observed in healthy individuals. To date, the Afrezza clinical programme has involved 49 different studies and over 5,000 adult patients.

MannKind Corporation focuses on the discovery, development and commercialization of therapeutic products for patients with diseases such as diabetes and cancer.