Biodel Inc. announced additional clinical data from its VIAject programme at the 43rd Scientific Sessions of the European Association for the Study of Diabetes (EASD).
According to the company press release, VIAject phase II meal study data was disclosed in an oral presentation at EASD entitled, "Pharmacokinetics and pharmacodynamics of insulin VIAject, insulin lispro and regular human insulin when injected subcutaneous immediately before a meal in patients with type 1 diabetes." The VIAject phase II meal study results demonstrated statistically significant and clinically relevant improved glycaemia control compared to regular human insulin (Humulin R) and lispro (Humalog).
"We are pleased that VIAject continues to yield improved pharmacokinetic and pharmacodynamic data when compared to both Humulin R and Humalog. These differences translate into better glycaemia control and fewer hypoglycaemic events which we continue to track in our ongoing phase III VIAject clinical trials," said, Dr. Solomon Steiner, chairman and chief executive officer, Biodel.
In the phase II meal study of VIAject, subjects received VIAject, Humulin R (regular recombinant human insulin) or Humalog (rapid acting insulin analog) in conjunction with a standardized meal. Plasma insulin and blood glucose levels were monitored throughout the study. Administration of VIAject resulted in statistically significantly faster insulin absorption than Humulin R and Humalog and lower plasma insulin levels than both after three hours. The data showed that VIAject provides better postprandial blood glucose control with less hyperglycemias in the first three hours after the meal and less risk of hypoglycaemia in the next five hours as compared to Humulin R and Humalog.
"The absorption of VIAject, especially after the first 30 minutes, is much more rapid when compared to regular insulin and lispro. Improvements in pharmacokinetic and pharmacodynamic parameters may translate into improved postprandial metabolic control, resulting in a safer treatment option for the diabetic population," said, Dr. Lutz Heinemann, CEO, Profil Institute for Metabolic Research in Neuss, Germany.
Biodel Inc. is a specialty biopharmaceutical company focused on the development and commercialisation of innovative treatments for endocrine disorders, such as diabetes and osteoporosis. Biodel's product candidates are developed by using VIAdel technology, which reformulates existing FDA- approved peptide drugs. The Company's lead product candidate, VIAject, is rapid-acting injectable mealtime insulin for use by patients with type 1 or type 2 diabetes. VIAject is currently being tested in two pivotal phase III clinical trials. Biodel's pipeline also includes VIAtab, a sublingual tablet formulation of insulin in phase I clinical trials and two osteoporosis product candidates in pre-clinical studies.