Biodel Inc. (Nasdaq: BIOD) today announced the initiation of a Phase 2 clinical trial of its proprietary recombinant insulin (RHI)-based ultra-rapid-acting mealtime insulin candidate, BIOD-123.
"We are pleased to achieve another milestone in the development of BIOD-123. We continue to meet our timelines and project that we will be able to communicate top-line Phase 2 safety and efficacy data in the third calendar quarter of 2013," stated Dr. Errol De Souza, president and chief executive officer of Biodel.
Dr. Alan Krasner, Biodel's Chief Medical Officer, stated: "This Phase 2 study is designed to assess the clinical impact of the ultra-rapid absorption profile of BIOD-123 relative to currently marketed mealtime insulin analogs. There is room for improvement in the area of mealtime insulin therapy and we are hopeful that this new candidate will help usher in a new insulin class designed to achieve better meal time outcomes for patients with diabetes."
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.
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.