Biodel Inc. (BIOD) announced positive preliminary data from a phase IIa study on its diabetes candidate, BIOD-531. The phase IIa Study 3-151 is comparing a concentrated insulin formulation, BIOD-531 to Eli Lilly and Company’s (LLY) Humalog Mix 75/25 and Humulin R U-500 in patients suffering from type I and type II diabetes with severe insulin resistance who use at least 150 units of insulin per day or at least 100 units of insulin in a single injection.
In the study, BIOD-531 was found to be superior in controlling glucose as compared to Humalog Mix 75/25 and Humulin R U-500 when the insulin was dosed immediately before breakfast. Additionally, BIOD-531 dosed after breakfast and dinner was found to be as effective as Humulin R U-500 dosed before the meals.
Humulin R U-500 is currently the only available concentrated insulin in the U.S. It is generally used to treat type II diabetes patients with severe insulin resistance who require very high doses of insulin (greater than 150 units per day).
However, Humulin R U-500 concentrated insulin has a suboptimal pharmacokinetic and pharmacodynamic profile for prandial coverage and a more delayed onset than U-100 regular human insulin or rapid-acting insulin analog formulations.
BIOD-531, combining ultra-rapid absorption with a basal duration profile, has the potential to improve meal-time glucose control.
Biodel holds a Zacks Rank #1 (Strong Buy). Other favorably ranked stocks in the health care sector include Affymetrix Inc. (AFFX) and Incyte Corporation (INCY). Both stocks carry the same Zacks Rank as Biodel.
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