Biodel Reports Positive Top-Line Results from Phase 1 Clinical Trial of BIOD-238 and BIOD-250
Biodel (NASDAQ: BIOD) today announced positive top-line results from a Phase 1 clinical trial of two ultra-rapid-acting insulin analog-based formulations, BIOD-238 and BIOD-250, conducted to evaluate the pharmacokinetic and injection site toleration profiles relative to Humalog®, a rapid-acting insulin analog. BIOD-238 and BIOD-250 are combinations of Biodel's proprietary excipients with the marketed formulation of Humalog®.
The single-center, randomized, double-blind, three-period crossover trial in 12 patients with Type 1 diabetes was conducted in Australia. Each study drug was administered subcutaneously on separate days. Pharmacokinetic measurements were made using an assay to quantify the active ingredients in the study drugs and Humalog®. The clinical trial was powered to measure differences in time to half-maximal insulin concentrations. The hypothesis tested in this study was than Biodel's formulations of Humalog® would have ultra-rapid absorption profiles with comparable declines from peak concentration and comparable injection site tolerability profiles relative to Humalog®. Two approaches were taken to mitigate injection site discomfort—reducing disodium EDTA concentrations (BIOD-238) and addition of magnesium sulfate (BIOD-250), which was