Published on January 21, 2010 at 10:08 AM
MDRNA, Inc. (NASDAQ: MRNA), 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.
SOURCE: MDRNA, Inc.