FDA lifts partial hold on Biodel’s BIOD-531 in diabetes

US endocrine specialist Biodel (Nasdaq: BIOD) says that the US Food and Drug Administration has removed the partial clinical hold for Biodel's previously initiated Phase IIb Study 3-250, a randomized, open-label, parallel group study in patients with insulin-treated type 2 diabetes comparing the use of BIOD-531 to Eli Lilly’s (NYSE: LLY) Humalog (insulin lispro) Mix 75/25.

Biodel shares rose 3.5% to $0.44 in mid-morning trading on Monday following the announcement. The FDA had previously stopped recruitment in the trial by requiring Biodel to provide additional data concerning the investigational U-400 syringe used to deliver BIOD-531. Additional syringe testing has been performed and was submitted to the FDA.

The correspondence from the FDA clears the use of Biodel's investigational U-400 syringes in the clinical trial. Additionally, in the fourth calendar quarter of 2015, the company will begin a Phase IIa standardized meal challenge study and independent market analysis to determine whether the target diabetes populations and market segments for BIOD-531 can be further expanded.