Biodel Inc. (BIOD) announced top-line results from a phase I 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-centre, randomized, double-blind, three-period crossover trial in eight 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 analogue 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 per cent 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 II clinical testing.

Dr Alan Krasner, Biodel's chief medical officer, stated: “These results are similar to what we observed in a previous phase I 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 programme.  Last month we reported our exciting data on the development of analogue-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 analogues. We plan to provide an update on our product development plans and timelines in the fourth calendar quarter of 2011.”

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.