Nastech Announces Positive Phase 1 Clinical Results of Insulin Nasal Spray Compared to Exubera(R) Inhalation Powder and NovoLog(C) Insulin Aspart Injection
Study shows Insulin Nasal Spray provides the fastest insulin response which may be especially useful for type 2 diabetic patients
BOTHELL, Wash., Dec. 6 -- Nastech Pharmaceutical Company Inc. (Nasdaq: NSTK - News) today announced results from a placebo controlled, dose-escalation, cross-over Phase 1 study of Nastech's proprietary insulin nasal spray formulations, NovoLog insulin aspart (rDNA origin) injection and Exubera (insulin human [rDNA origin]) Inhalation Powder in healthy subjects.
Twelve subjects participated in a six treatment, cross-over study in which one treatment of a nasal placebo, three doses of a proprietary intranasal formulation of regular human insulin, one treatment of rapid-acting insulin aspart injection, a rapid-acting insulin analogue, and one treatment with insulin human inhalation powder. Plasma insulin and glucose levels were measured at 12 time points up to six hours and pharmacokinetic parameters, including Tmax, Cmax, and AUClast were determined.
With respect to time to maximum plasma level for insulin or Tmax, the three nasal doses had Tmax values of 16 to 19 minutes and were the fastest compared to the rapid-acting insulin aspart and inhaled insulin. With respect to plasma insulin levels, rapid-acting insulin aspart injection had the highest concentration, followed by the three nasal formulations, with inhaled insulin having the lowest. With respect to the extent of absorption, rapid- acting insulin aspart injection had the greatest total exposure or AUClast, with the highest dose of three nasal formulations next, followed by the inhaled insulin and then the lowest doses of two nasal spray formulations.
The pharmacokinetic-pharmacodynamic relationship demonstrated a high correlation between either Cmax or AUClast and the maximum glucose response. One subject was dropped from the study due to hypoglycemia after receiving insulin aspart injection; otherwise, there were no side effects, including clinically significant hypoglycemia.
"The rapid absorption of a nasal product may have a unique value proposition compared with other insulin formulations on the market, especially in type 2 patients who have adequate insulin stores but a slow post-meal insulin response," said Dr. Harold E. Lebovitz, Professor of Medicine in the Division of Endocrinology at the State University of New York (SUNY) Health Science Center at Brooklyn. "A rapidly acting insulin may complement the remaining natural capacity in such patients."
"This study was designed to determine if Nastech's nasal spray formulations of regular human insulin would act faster than a rapid-acting injection formulation and would deliver more insulin than the recently approved, inhaled insulin and both of those goals were achieved with these initial formulations," stated Steven C. Quay, M.D., Ph.D., Chairman, President and CEO of Nastech. "We plan to conduct additional formulation work to increase both bioavailability and the duration of effect and will continue to develop insulin nasal spray based on its potential to become a safe and effective non-invasive insulin therapy for diabetes. The current study protocol has been expanded to include additional formulations and this study continues at this time."
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 sales in the United States were approximately $1 billion in the third quarter of 2006. The total direct and indirect economic cost related to diabetes in 2002 was estimated to be $132 billion annually in the United States.
About Nastech
Nastech is a pharmaceutical company developing innovative products based on proprietary molecular biology-based drug delivery technologies. Nastech and its collaboration partners are developing products for multiple therapeutic areas including osteoporosis, diabetes, obesity, respiratory diseases and inflammatory conditions. Additional information about Nastech is available at http://www.nastech.com.
Nastech Forward Looking Statements
Statements made in this press 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 to obtain additional funding; (ii) the ability of Nastech to attract and/or maintain manufacturing, research, development and commercialization partners; (iii) Nastech's and/or a partner's ability to successfully complete product research and development, including preclinical and clinical studies and commercialization; (iv) Nastech's and/or a partner's ability to obtain required governmental approvals; and (v) Nastech's and/or a partner's ability 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.