Nastech Pharmaceutical Company Inc. (Nasdaq: NSTK) announced today data from a Phase II clinical trial demonstrating that its ultra rapid acting intranasal insulin was both superior to usual therapy (oral anti-diabetic medicines and/or basal insulin) and non-inferior to insulin aspart (NovoLog®), a rapid-acting injectable insulin, in maintaining glucose control at both 60 and 90 minutes following a meal. The data also demonstrated a statistically significant reduction in the incidence of hypoglycemia (low blood sugar <70 mg/dL) compared with insulin aspart in the four hours following the meal. The data were reported at the 68th Scientific Sessions meeting of the American Diabetes Association in San Francisco in an oral presentation by Professor Lutz Heinemann, Ph.D., of the Profil Institute for Metabolic Research Ltd., and in a Nastech poster presentation.
“The data from our Phase II intranasal insulin study show a combination of very desirable attributes: efficacy similar to that of the best mealtime insulin treatment, the safety advantage of lower rates of post-meal hypoglycemia, the further safety advantage of not getting into the lungs, and the convenience of a nasal spray,” said Steven C. Quay, M.D, Ph.D., Chairman and CEO of Nastech.
As noted by Dr. Sherwyn Schwartz, Principal Investigator with dgd Research, now a member of Cetero Research, “Currently, Type 2 diabetic patients’ mealtime glucose is less well controlled than it needs to be to attain good diabetes control. Patients avoid rapidly acting injected mealtime insulin for a variety of reasons, including a fear of needles, the perception that having to inject medication indicates a more serious disease, and concerns over hypoglycemia. The characteristics of Nastech’s intranasal insulin may represent an important advantage for doctors and patients attempting to gain better control of mealtime glucose.”
Results of the trial demonstrated that both intranasal insulin and NovoLog were significantly better at 60 and 90 minute glucose control than the patient’s usual therapy, which typically consisted of oral diabetic medications. The study’s primary endpoint was proven: that intranasal insulin was non-inferior for 60 and 90 minute glucose change from baseline compared with insulin aspart. Importantly, intranasal insulin demonstrated a significantly lower incidence (three percent, or one of 29 patients) of hypoglycemia (glucose level <70 mg/dl) compared to insulin aspart (21 percent or six of 29 patients; p=0.025) during the four hours post meal. In addition, the time to maximum concentration for intranasal insulin was faster (30 minutes) than for insulin aspart (90 minutes), which further demonstrates the ultra rapid-acting nature of the product.
“The study results are also very important in the context of concerns about inhaled insulin. Our product is different from recently cancelled pulmonary insulin programs because there is little to no pulmonary exposure,” Dr. Quay continued. “In addition, our intranasal insulin product does not require refrigeration, is easy to use and provides convenience for patients.”
The Phase II study involved 29 Type 2 diabetics, mean aged 57, with an average duration of diabetes of 7.3 years. The patients ate a standard meal on each study day. On day one of the study, they took their usual therapy and glucose levels were monitored. During subsequent days, patients were randomized to receive either an optimized insulin aspart dose or an optimized intranasal insulin before the meal.
About Diabetes and Insulin
In the United States, approximately 21 million people have diabetes and 1.5 million new patients are diagnosed every year, according to the American Diabetes Association. Type 2 diabetes accounts for an estimated 90 to 95 percent of all cases. Complications can include cardiovascular disease, kidney disease, blindness and diseases of the central nervous system. Injectable insulin has been used to treat diabetes since the early 1920s and continues to be the definitive treatment for diabetes worldwide. Branded insulin product sales were approximately $9 billion worldwide in 2006. The total direct and indirect economic cost related to diabetes in 2002 was estimated to be $132 billion annually in the United States.
Nastech is a clinical stage biopharmaceutical company focusing on the development and commercialization of innovative therapeutic products based on its proprietary ribonucleic acid interference technology and its proprietary molecular biology-based drug delivery technologies. Nastech and its collaboration partners are developing products for multiple therapeutic areas including diabetes, obesity, osteoporosis, autism, respiratory diseases and inflammatory conditions. Additional information about Nastech is available at http://www.nastech.com.
Nastech Forward Looking Statement
Statements made in this news release may be forward-looking statements within the meaning of Federal Securities laws that are subject to certain risks and uncertainties and involve factors that may cause actual results to differ materially from those projected or suggested. Factors that could cause actual results to differ materially from those in forward-looking statements include, but are not limited to: (i) the ability of Nastech or a subsidiary to obtain additional funding; (ii) the ability of Nastech or a subsidiary to attract and/or maintain manufacturing, research, development and commercialization partners; (iii) the ability of Nastech, a subsidiary and/or a partner to successfully complete product research and development, including preclinical and clinical studies and commercialization; (iv) the ability of Nastech, a subsidiary and/or a partner to obtain required governmental approvals; and (v) the ability of Nastech, a subsidiary and/or a partner to develop and commercialize products that can compete favorably with those of competitors. Additional factors that could cause actual results to differ materially from those projected or suggested in any forward-looking statements are contained in Nastech's most recent periodic reports on Form 10-K and Form 10-Q that are filed with the Securities and Exchange Commission. Nastech assumes no obligation to update and supplement forward-looking statements because of subsequent events.