MicroDose announces positive results from the QDose inhaled insulin glucose clamp study
- Category: Proteins and Peptides
- Published on Monday, 06 August 2007 04:00
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MONMOUTH JUNCTION, NJ, USA | August 6, 2007 | MicroDose Technologies, Inc., a privately held drug delivery and specialty pharmaceuticals company, today announces top line results from a glucose clamp study of the QDose inhaled insulin product. MicroDose, through its joint venture with Vectura Group plc, QDose Limited, has developed a highly efficient, rapid acting, insulin inhaler, based upon MicroDose's proprietary electronic inhaler technology and Vectura's dry powder insulin formulation. The QDose inhaled insulin product offers dose titration capability over a broad range of dose strengths, in a single inhalation. The inhaler also provides active dose feedbacks to the patient in an easy to use, pocket-sized device.
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The study employed the widely used and validated glucose clamp technique, and results demonstrated that:
-- The inhaled insulin formulation was safe and effective
-- Peak levels of insulin activity were achieved more quickly following the inhaled insulin than those from the subcutaneous insulin injection
-- Relative bioavailability of inhaled insulin was approximately 18% during the 3 hour period following dosing; higher than the published values for the currently marketed inhalation product
-- Administration of the same total dose of inhaled insulin from either a single blister or two "half strength" blisters led to equivalent activity; an advantage over the currently marketed inhalation product
The study was a randomized, crossover, open-label glucose clamp study,designed to confirm the high relative bioavailability of the QDose insulin formulation previously observed, and to demonstrate the product's dose titration capability. The results confirmed the faster onset of action seen with the QDose inhaled formulation compared with subcutaneous insulin. The relative bioavailability observed in this study compares favorably with available information on competitor inhaled insulin programs. The study was conducted in the United States at Profil Institute for Clinical Research Inc (Profil) in San Diego, with 14 healthy male volunteers, using a glucose clamp technique. Profil has research facilities in the US and Germany and is the leading institute in the world for euglycaemic, hyperglycaemic and hypoglycaemic glucose clamps.
Anand Gumaste, Ph.D., Chief Executive Officer of MicroDose, commented:
"Treatment of diabetes with insulin has historically been challenging, having to overcome the psychological barriers to injection, allowing for individual patient titration of dose, all while satisfying the varying needs of a broad continuum of patient populations. The QDose product's ability to meet these needs, coupled with its user friendly aspects, gives
it a significant advantage in the market place. We are currently seeking a licensing partner for the continued development and commercialization of this unique product."
About MicroDose Technologies
MicroDose Technologies, Inc., based in Monmouth Junction, New Jersey, is a leading privately-held drug delivery and specialty pharmaceuticals company, developing advanced pulmonary, fixed-dose-combination oral dosage, and other technologies for the pharmaceutical and biotechnology industries. MicroDose Technologies has a two-fold business strategy, 1) to create improved partnered products by combining its proprietary drug delivery technologies with pharmaceutical company compounds, and 2) to develop products in-house using its proprietary delivery technologies with generic drug substances.
MicroDose's dry powder inhaler platform is a handheld, low cost, breath activated technology which utilizes piezo electronics to efficiently deliver a broad range of compounds independent of inhalation effort. Partnered programs for the inhaler include; a multi-product development and licensing agreement with Novartis for its proprietary respiratory compounds, and an inhaler for the systemic delivery of a nerve agent antidote for the US Department of Defense in co-development with the University of Pittsburgh. In addition, MicroDose has undisclosed collaborations ongoing with major pharmaceutical partners in the respiratory market segment.
MicroDose's second drug delivery platform, PolyCap(TM), is a fixed-dose-combination oral dosage technology, which allows two or more drugs to be combined in a single capsule, but separated by a physical barrier. Internal development programs utlilizing PolyCap(TM) are underway in the areas of diabetes, hypertension and hyperlipidaemia. PolyCap(TM) is also available for license to pharmaceutical partners for their combination product needs.
For further information please visit MicroDose's website at http://www.microdose-tech.com
Diabetes is a chronic health condition where the body is unable to produce or adequately use insulin. Diabetes is broadly grouped into two types -- Type I and Type 2. Type 2 diabetics make up approximately 90% of all diabetics and the incidence of Type 2 diabetes is growing rapidly. According to the World Health Organization, diabetes is reaching epidemic proportions. Approximately 194 million people worldwide suffer from the disease, and it is estimated that the number of people with diabetes will more than double by 2030. Predictions are that one in three children in the U.S. born five years ago will develop diabetes. Direct healthcare costs may be as much as $286 billion worldwide. It is widely accepted that early intervention for Type 2 diabetics by treatment with insulin improves outcomes. However, as Type 2 diabetics are reluctant to inject insulin the introduction of non-invasive insulin delivery formats, such as inhalable insulin, is likely to have greater impact on outcomes and become the preferred means for delivering insulin for Type 2 diabetics. The first inhalable insulin product, Pfizer's EXUBERA(R), was approved by the European Commission on January 26th 2006 and by the FDA on January 27th 2006. Following the launch of EXUBERA(R) inhaled insulin has become available for diabetics and the way is being paved for next generation products.
About Glucose Clamp Technique
Glucose clamp technique is a technique that maintains a constant blood glucose level in human subjects by perfusion or infusion with glucose; the technique is used in studies to obtain evidence of the effectiveness and bioavailability of preparations of insulin in healthy human volunteers, and patients who suffer from diabetes.
Glucose clamp techniques represent the gold standard for pharmacodynamic and pharmacokinetic studies to describe the time-action profiles of glucose-lowering drugs; the effects of these drugs administered
by various routes of administration can be studied individually, and then compared. For example, the effects of inhaled versus subcutaneous insulin.
The European regulatory authority EMEA expressly refers to the glucose clamp technique in an EMEA/ CPMP Note for Guidance.
SOURCE: MICRODOSE TECHNOLOGIES, INC.