Independent investigator begins pump trial of Biodel's two ultra-rapid human insulin formulations

Biodel Inc. (Nasdaq: BIOD) announced today that an independent investigator initiated a pump trial of Biodel's two ultra-rapid-acting formulations of recombinant human insulin.

The formulations, BIOD-105 and BIOD-107, are designed to result in more rapid insulin action compared to currently marketed mealtime insulin analogs.  This study is designed as a double blinded, three-period cross over trial in which insulin pumps will be used to deliver BIOD-105, BIOD-107 and Humalog® each at separate dosing visits in approximately 8 patients with type 1 diabetes.  This study, expected to be completed in the fourth calendar quarter of 2011, will evaluate pharmacokinetic, pharmacodynamic and injection site tolerability profiles of BIOD-105 and BIOD-107 relative to that of Humalog®.   Drs. W. Kenneth Ward and Jessica Castle of the Division of Endocrinology, Diabetes, and Clinical Nutrition at Oregon Health and Sciences University will serve as principal investigators for this trial.

Insulin pump therapy, also known as continuous subcutaneous insulin infusion (CSII), is used as a means to provide intensive insulin therapy to patients with diabetes.  Currently available prandial insulins are used in pumps, but often are not absorbed rapidly enough to achieve optimal mealtime glucose control.  It is believed that an ultra-rapid-acting insulin will be better suited for pump therapy than currently marketed mealtime insulin analogs.

"We look forward to evaluating BIOD-105 and BIOD-107 in insulin pump patients," said Dr. W. Kenneth Ward.  "An insulin with faster absorption has the potential to better match insulin delivery with the rapid need for insulin following meals.  Such an insulin might not only allow for better glucose control with today's insulin pumps but may also help lead to a functional artificial pancreas system, in which insulin delivery is automated based on minute to minute changes in blood glucose levels."

"In the third week of March we initiated a study of similar design to Dr. Ward's study in which BIOD-105, BIOD-107 and Humalog^® are delivered by standard injection," said Dr. Alan Krasner, Chief Medical Officer of Biodel.  "The results of both studies will help choose the best candidate for further development.  We look forward to receiving these data."