DiabetesSource

MDRNA, Inc., a leading RNAi-based drug discovery and development company, today announced that the European Patent Office intends to grant a patent for application EP06826368 covering formulations for the intranasal delivery of rapid acting insulin, and its use for the treatment of diabetes.

"While our focus remains the development of RNAi-based therapeutics, we believe that the intranasal assets from our predecessor company, Nastech Pharmaceuticals, have considerable value," said J. Michael French, President and CEO of MDRNA. "Specifically, we believe that our insulin intellectual property assets, with the positive results from the Phase II clinical trial completed in 2008, have out-licensing potential."

The intranasal formulation would help people with diabetes, for whom managing blood sugar levels within acceptable limits is a constant challenge. Post-meal glucose levels frequently "spike" requiring immediate insulin intervention. However, there is a risk that such interventions can lead to excess insulin in the blood stream resulting in post-meal hypoglycemia (or low blood sugar levels). Intranasal insulin taken after a meal reduces hypoglycemia significantly faster than injectable insulin.

The proprietary intranasal insulin formulation covered by EP06826368 provides for a rapid-acting therapy using non-modified forms of insulin. Phase II clinical studies have demonstrated that the intranasal insulin formulation was superior to oral anti-diabetic medications and non-inferior to injectable insulin for control of blood glucose immediately (60 and 90-minutes) after a meal. Intranasal insulin provided a significant reduction in hypoglycemia at 4 hours after a meal, as compared to injectable insulin. These attributes are expected to provide for improved glycemic control. Importantly, the nasal administration did not result in insulin entering the lungs, further improving the potential safety profile of this product. The nasal delivery device used in the trials is compact and easily stored for patient convenience.

About MDRNA, Inc.
MDRNA is a biotechnology company focused on the development and commercialization of therapeutic products based on RNA interference (RNAi). Our goal is to improve human health through the development of RNAi-based compounds and drug delivery technologies that together provide superior therapeutic options for patients. Over the past decade, we have developed substantial capabilities in molecular biology, cellular biology, lipid chemistry, peptide chemistry, pharmacology and bioinformatics, which we are applying to a wide range of RNAi technologies and delivery approaches. These capabilities plus the in-licensing of key RNAi-related intellectual property have rapidly enabled us to become a leading RNAi-based therapeutics company with a pre-clinical pipeline in oncology. Through our capabilities, expertise and know-how, we are incorporating multiple RNAi technologies as well as peptide- and lipid-based delivery approaches into a single integrated drug discovery platform that will be the engine for our clinical pipeline as well as a versatile platform for establishing broad therapeutic partnerships with biotechnology and pharmaceutical companies. We are also investing in new technologies that we expect to lead to safer and more effective RNAi-based therapeutics while aggressively building upon our broad and extensive intellectual property estate. By combining broad expertise in siRNA science with proven delivery platforms and a strong IP position, MDRNA is well positioned as a leading RNAi-based drug discovery and development company.