Biodel has initiated a Phase 2 clinical trial of its proprietary recombinant insulin (RHI)-based ultra-rapid-acting insulin candidate, BIOD-123. The study is designed to assess the clinical impact of the ultra-rapid absorption profile of BIOD-123 relative to currently marketed mealtime insulin analogs. In April 2012, Biodel announced positive top-line results from a Phase 1 clinical trial of BIOD-123, which demonstrated that the formulation had a more rapid absorption than insulin lispro, sold as Humalog®, with comparable injection site tolerability. Biodel expects to be able to communicate top-line Phase 2 safety and efficacy data in the third calendar quarter of 2013.
The Phase 2 study is a randomized, open label parallel group study enrolling 130 patients with type 1 diabetes at approximately 30 U.S. investigative centers. The patients are randomized to receive either BIOD-123 or insulin lispro as their mealtime insulin over an 18 week treatment duration. Both arms of the study use insulin glargine, sold as Lantus, as the basal insulin. The primary endpoint compares changes in HbA1c, while secondary endpoints compare postprandial glucose excursions, glycemic variability, hypoglycemic event rates and weight changes.
