MannKind Corporation has presented desirable features of insulin delivery and glucose control with its Technosphere/Insulin system at the Annual Meeting of the European Association for the Study of Diabetes being held in Munich, Germany.
Currently in late stage Phase II clinical trials in the United States and Europe, the MannKind product is being developed to treat both type 1 and type 2 diabetes mellitus.
Dr. Wendell Cheatham, corporate vice president for Medical & Regulatory Affairs of MannKind Corporation and an Endocrinologist/Diabetologist, described the ability of Technosphere/Insulin to produce a rapid increase in blood insulin level that approximates the normal early release of insulin that is observed in healthy individuals in response to a meal.
Dr Cheatham noted that this early insulin signalling spike is lost in patients who suffer from both type 1 and type 2 diabetes and commented, "There is currently no marketed form of therapy for diabetes that has been able to replace or restore the signalling function of the healthy pancreas. This rapid signal is not directly involved in glucose disposal, but is needed to stop release of glucose from the liver when nutrients are being ingested in a meal."
"Glucose is released by the liver to fuel the body between meals, but this additive glucose is undesirable during and shortly after absorption of nutrients from a meal. Turning off the release of glucose from the liver during this meal-time period is extremely important in controlling blood sugar levels," he added.
Dr. Cheatham presented data on the speed of absorption and pharmacological characteristics of MannKind's inhaled insulin that were similar to results seen when regular insulin was injected directly into the blood stream. In addition, the Technosphere/Insulin system was shown to have an effect that spans the period of meal digestion and absorption. Dr. Cheatham also described a model of human glucose dynamics that MannKind developed in order to better understand why the effect of its inhaled insulin is different from that produced by insulin given via subcutaneous injection and why it is more similar to the effect of insulin given by intravenous injection. MannKind plans to present information from completed Phase II studies of its inhaled Technosphere/Insulin to the US FDA before the end of 2004.
MannKind focuses on the discovery, development and commercialization of therapeutic products for diseases including diabetes, cancer, inflammatory and autoimmune diseases.