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-based ultra-rapid-acting insulin formulations and we continue to aggressively implement our two-pronged strategy of developing ultra-rapid-acting prandial formulations of both recombinant human insulin and insulin analogs. We plan to provide an update on our product development plans and timelines in the fourth calendar quarter of 2011." Dr. De Souza will present a company update today at 8:30 a.m. ET at the 6th Annual JMP Securities Healthcare Conference in New York. To listen to the live webcast or a replay of the presentation, please visit the Investors section of the company's website at www.biodel.com. A replay will be available for 90 days after the event. About Biodel Inc. Biodel Inc. is a specialty biopharmaceutical company focused on the development and commercialization of innovative treatments for diabetes that may be safer, more effective and more convenient for patients. We develop our product candidates by applying our proprietary formulation technologies to existing drugs in order to improve their therapeutic profiles. For further information regarding Biodel, please visit the company's website at www.biodel.com. BIOD-G