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Biodel Reports Top-Line Results From Pump Study of Experimental Insulins
Date:9/27/2011

DANBURY, Conn., Sept. 27, 2011 /PRNewswire/ -- Biodel Inc. (Nasdaq: BIOD) today announced top-line results from a Phase 1 clinical trial of BIOD-105 and BIOD-107 at Oregon Health and Sciences University to evaluate the pharmacokinetic, pharmacodynamic and infusion site tolerability profiles of these ultra-rapid-acting formulations of recombinant human insulin, relative to Humalog®, when delivered by insulin pumps.    

The trial was a single-center, randomized, double-blind, three-period crossover trial in 8 subjects with Type 1 diabetes.  Each study drug was administered on separate days.  Pharmacodynamics were assessed using the euglycemic clamp method.  Local infusion site discomfort was measured with a 100 mm visual analog scale and patient questionnaires.  

In this study, BIOD-105 and BIOD-107 demonstrated slightly more rapid absorption (as reflected by the mean time to 50% maximal insulin concentration), and markedly slower declines from peak effect than Humalog® with no significant differences among the three drugs regarding infusion site toleration.  The two Biodel formulations did not meet the company's target product profile and, therefore, will not be advanced into Phase 2 clinical testing.

Dr. Alan Krasner, Biodel's chief medical officer, stated: "These results are similar to what we observed in a previous Phase 1 study reported last month and indicate that we have achieved comparable tolerability to Humalog®, but they do not support further development of these candidates at this time."  

Dr. Errol De Souza, Biodel's president and chief executive officer, stated: "The findings from these studies have been instructive as we continue to pursue our ultra-rapid-acting prandial insulin development program.  Last month we reported our exciting data on the development of analog-ba
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SOURCE Biodel Inc.
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