Biodel Announces Removal Of Partial Clinical Hold For BIOD-531 - Quick Facts

(RTTNews) - Biodel Inc. (BIOD) said Monday that the United States Food and Drug Administration or FDA has removed the partial clinical hold for the company's previously initiated Phase 2b 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 Humalog Mix 75/25. 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 2a 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.

The Phase 2a standardized meal challenge study will evaluate the hypothesis that treatment with BIOD-531 can reduce the injection burden and achieve glucose control at least as effective as that with separate basal and prandial insulins in patients with type 2 diabetes.

The market analysis will assess the optimal target patient populations and commercial opportunity for BIOD-531, including patients who are on intensive basal/prandial insulin therapy.

The company noted that it has decided to continue Study 3-250 to allow completion of patients currently in the trial while deferring recruitment of new patients until the optimal target population(s) have been selected following review of top-line data from the new Phase 2a meal study and the results of the market analysis in the first calendar quarter of 2016.