Biodel reports preclinical test results of BIOD620 glucose-regulated or "smart" basal insulin product candidate

Biodel Inc. (Nasdaq: BIOD) today reported results of preclinical tests which demonstrated the potential of the company's glucose-regulated or "smart" basal insulin product candidate, BIOD620, to release insulin proportionally in response to changing glucose conditions.  In an oral presentation today at the 37th Annual Meeting and Exposition of the Controlled Release Society in Portland, Oregon, Nandini Kashyap, director of novel drug delivery at Biodel, described results of in vitro and in vivo studies with diabetic pigs which compared the use of BIOD620 to Lantus® (insulin glargine).  BIOD620 is Biodel's proprietary injectable formulation of insulin glargine that has been designed to alter its insulin release profile in response to changing glucose concentration.

Six fasted diabetic pigs received a subcutaneous injection of 0.25U/kg of BIOD620 or Lantus®. Their blood glucose was monitored every 15 minutes. Six hours after receiving their initial injection, they were fed 500 grams of food as a glucose challenge.  BIOD620 was able to reduce the elevated plasma glucose levels faster than the group receiving Lantus®. Furthermore, post-meal hyperglycemia was reduced more rapidly in the BIOD620 group than in the control group.

"Current basal insulins cannot respond to conditions that affect glucose levels, such as exercise and stress, and are often administered at inappropriately high doses.  This study supports the hypothesis that BIOD620 released insulin in response to changing glucose conditions and is a truly self-regulating formulation that may translate to clinically relevant conditions," Ms. Kashyap noted.   "We found that BIOD620 was able to manage plasma glucose levels more rapidly than basal insulin alone.  Based on these findings, which we hope to test in clinical studies, we believe that BIOD620 insulin has the potential to be a significant improvement over basal insulin currently used by patients with diabetes mellitus."

Dr. Solomon Steiner, chief scientific officer of Biodel, commented:  "We are excited about these results because they suggest we have developed a new form of basal insulin that adjusts automatically to changing glucose levels."

At the same conference, Biodel also reported findings from a preclinical study exploring the effect of disodium EDTA concentration in VIAject® (ultra-rapid-acting injectable human insulin) on the drug's speed of action in diabetic pigs.  EDTA is one of two key excipients used in VIAject® which affect the rapid dissociation of insulin hexamers into monomers and the subsequent rapid absorption of insulin.  In a poster presentation, Dr. Roderike Pohl and colleagues from Biodel described results of a study of eight diabetic pigs showed that reduced amounts of EDTA produced  lower insulin concentrations and less rapid absorption of insulin, although the duration of insulin action remained essentially the same regardless of the EDTA concentration.  The authors concluded that the study demonstrated a systematic relationship between the concentration of EDTA and the speed of absorption, confirming that sufficient EDTA is required to achieve the ultra-rapid absorption profile and pharmacodynamic action of VIAject®.

Abstracts summarizing the oral presentation by Ms. Kashyap ("Smart" Basal Insulin Formulation That Releases Insulin in Response to Blood Glucose Concentrations of Diabetic Swine) and the poster presentation by Dr. Pohl (Effect of EDTA Concentration on Ultra-Rapid Action of VIAject® in Diabetic Miniature Swine) are available on Biodel's website, www.biodel.com.  

SOURCE Biodel Inc.