MannKind has presented new data on its inhaled insulin product that suggest it may not only make dosing the drug more convenient, but also improve efficacy compared to insulin injections.
The company's insulin candidate is currently in Phase II testing in Europe and the US and is based on MannKind's proprietary TechnoSphere drug delivery technology.
The new data, presented yesterday at the Annual Meeting of the European Association for the Study of Diabetes (EASD) in Munich, found that TechnoSphere insulin was able 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.
The challenge for insulin therapy is to get as close as possible to the natural pattern of insulin release, as this provides the best control of blood glucose and so should be more effective in warding off the debilitating complications of diabetes - heart disease, weight gain and eye and nerve damage.
Wendell Cheatham, corporate vice president for medical and regulatory affairs of MannKind, told the EASD that this early insulin signalling spike is lost in patients who suffer from both type 1 and type 2 diabetes. Moreover, there is currently no marketed form of therapy for diabetes that has been able to replace or restore this signal.
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 additional 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 said.
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.
MannKind plans to present information from completed Phase II studies of its inhaled insulin - which consists of a dry-powder Technosphere formulation of insulin and MedTone inhaler through which the powder is inhaled into the deep lung - to the US Food and Drug Administration before the end of 2004.
The company is trailing the field somewhat with its inhaled insulin product, with the lead candidate Exubera - developed by Nektar Therapeutics alongside Pfizer and Aventis - already filed for approval in Europe.
But the latter product has been subject to rumours of reluctance by the Eurpean Medicines Agency to approve it, following the results of studies showing a deterioration in lung function after exposure to the drug.
Meanwhile, another inhaled insulin drug from Alkermes and Eli Lilly has just started Phase III testing. Analysts have predicted that the first inhaled insulin product to reach the market could achieve sales upwards of $1.5 billion (€1.2bn) a year.