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Biodel Inc. announced today the publication of positive findings from studies demonstrating the superior metabolic profile of VIAject(TM) ultra rapid-acting insulin compared to the rapid-acting analog, Humalog(R), and regular human insulin in healthy volunteers and compared to regular human insulin in patients with type 1 diabetes
DANBURY, CT, USA | July 23, 2008 | Biodel Inc. (Nasdaq: BIOD) announced today the publication of positive findings from studies demonstrating the superior metabolic profile of VIAject(TM) ultra rapid-acting insulin compared to the rapid-acting analog, Humalog(R), and regular human insulin in healthy volunteers and compared to regular human insulin in patients with type 1 diabetes. The articles appear in the current issues of the journals Diabetologia and Journal of Diabetes Science and Technology.
In the Phase I glucose clamp study (Steiner et al., Diabetologia, 2008), ten healthy volunteers received subcutaneous injections of VIAject(TM) ultra rapid-acting insulin, insulin lispro (Humalog(R)) or regular human insulin on separate days. The study showed that VIAject(TM) was absorbed and produced its metabolic effect faster than both regular human insulin and insulin lispro (Humalog(R)) at the same dose.
In a Phase II glucose clamp study (Hompesch et al., J. of Diabetes Science and Technology, July 2008), fourteen patients with type 1 diabetes were randomly assigned to receive two sequences of three subcutaneous injections of 0.1 IU/kg of VIAject(TM) or regular human insulin on separate days. Patients receiving VIAject(TM) had an earlier onset of action and shorter time to maximal plasma insulin concentration when compared to regular human insulin, confirming previous findings in healthy volunteers that VIAject(TM) is absorbed more quickly and has a more rapid onset of action and clearance than regular human insulin.
"We welcome the publication of these earlier findings. These data led to the pivotal Phase III clinical trials assessing efficacy and safety in patients with Type1 and Type 2 diabetes," stated Dr. Solomon Steiner, chief executive officer and chairman of Biodel. "The last patients recently completed these pivotal Phase III trials and we look forward to analyzing and reporting these data."
About VIAject(TM)
VIAject(TM) is an ultra rapid-acting injectable human insulin intended for meal-time use by patients with Type 1 or Type 2 diabetes. In Phase I and Phase II clinical trials, VIAject(TM) has been shown to have a more rapid onset of activity than those reported for the existing rapid-acting insulin analogs. As a result, VIAject(TM) may be safer, require a lower dose and promote weight loss when compared to currently marketed meal-time insulins. VIAject(TM) has been tested in two pivotal Phase III clinical trials, which compared the effects of VIAject(TM) to Humulin(R) R, the leading recombinant human insulin.
About Biodel Inc.
Biodel Inc. is a specialty biopharmaceutical company focused on the development and commercialization of innovative treatments for endocrine disorders, such as diabetes and osteoporosis. Biodel's product candidates are developed by using VIAdel(TM) technology, which reformulates existing FDA-approved peptide drugs. The company's lead product candidate, VIAject(TM), is an ultra rapid-acting injectable meal-time insulin in development for use by patients with type 1 or type 2 diabetes. VIAject(TM) has been tested in two pivotal Phase III clinical trials. Biodel's pipeline also includes VIAtab(TM) a sublingual tablet formulation of insulin in the Phase I stage of clinical testing, and two pre-clinical osteoporosis product candidates. For further information regarding Biodel, please visit the company's website at www.biodel.com.
SOURCE: Biodel Inc. |
