Monmouth Junction, NJ, USA, 4th December 2001— MicroDose Technologies Inc. ( MicroDose ), a leading drug delivery company, announced today the successful completion of a Phase I clinical study evaluating the pulmonary delivery of human insulin, being conducted with joint venture partner, Elan Corporation, plc ( Elan ). This is the first clinical study to evaluate Elan s proprietary dry powder formulations of insulin in combination with MicroDose s novel dry powder inhaler (DPI) and initial results indicate significantly improved bioavailability compared with competitive products currently in development.
This rapid acting insulin product has been developed by QDose, a joint venture company established between Elan and MicroDose, and will be targeted at the treatment of both Type I and II diabetes as a patient-friendly and convenient approach to replacing the subcutaneous insulin injections required to control mealrelated glucose levels.
The UK-based study was conducted in 18 healthy male volunteers and was designed to demonstrate the efficiency of delivery of Elan s dry powder insulin from the MicroDose device. Blood levels of insulin and glucose were measured over time following inhalation of either pure insulin or an insulin-trehalose formulation (a formulation designed to allow long term storage at room temperature). Pulmonary delivery was compared with subcutaneous injected insulin, as a control.
Absorption of the inhaled insulin was rapid with a T max (time to maximum blood concentration) of 37-39 minutes (depending on the formulation) compared with a T max of 102 minutes for the subcutaneous insulin control, providing the opportunity for more rapid and complete control of blood glucose levels at meal times compared with conventional insulin injections. The bio-availability over the initial 3 hours of the inhaled insulin relative to the subcutaneous dose was 23-25% depending on the formulation. These data compare extremely favourably with those of competitor approaches in pulmonary drug delivery.
The MicroDose DPI is an active, multi-unit dose device, which achieves high efficiency powder dispersion independent of patient inhalation effort and has demonstrated excellent dose reproducibility. It is designed to be a lightweight, low cost, pocket-sized device.
These Phase I results are extremely encouraging said Anand Gumaste, CEO of MicroDose. Clearly we are in a highly competitive field, but the outcome of the study positions us strongly as we seek a development partner and move this product through development. For MicroDose, this is the first time that this inhaler device has been tested in clinical trials. The results of this pioneering study are very exciting and prove our ability to develop technologies which deliver active molecules to the required sites of action quickly and effectively. The performance levels we have observed demonstrate clear potential to evaluate other bioactive molecules using this device, commented Scott Fleming, Vice President, Marketing, MicroDose.