Biodel’s ultra-rapid-acting formulations of recombinant human insulin, BIOD-105 and BIOD-107, failed to meet the company’s target product profile in the second phase 1 clinical trial at Oregon Health and Sciences University and will therefore not be advancing to phase 2 trials. The top-line results from the phase 1 clinical trial of BIOD-105 and BIOD-107 was meant 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.
Following these results the company said it would continue its ultra-rapid-acting prandial insulin program of both recombinant human insulin and insulin analogs. The company plans to provide an update on product development plans and timelines in the fourth calendar quarter of 2011.