Biodel (BIOD) Announces Initiations of BIOD-531 Phase 2b

May 21, 2015 7:15 AM EDT
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Biodel (NASDAQ: BIOD) announced the initiation of a Phase 2b clinical trial of BIOD-531, the Company's concentrated, proprietary, recombinant human insulin (RHI) based ultra-rapid-acting prandial/basal combination insulin candidate.

The Phase 2b trial, Study 3-250, is a randomized, open-label, parallel group study in patients with insulin-treated type 2 diabetes. Approximately 130 patients are targeted for enrollment at 25 U.S. investigative centers. Patients will be randomized to receive either BIOD-531 or Humalog® Mix 75/25 dosed twice daily. Patients will be treated for 18 weeks, the first six weeks of which will focus on active dose titration. The primary analysis will evaluate change from baseline in HbA1c, while secondary endpoints will compare postprandial glucose excursions, hypoglycemic event rates and weight changes. Top line results are expected in mid-2016.

Dr. Errol De Souza, Biodel's president and chief executive officer, stated: "BIOD-531 has shown in three clinical studies to be associated with a best-in-class, ultra-rapid insulin profile and a basal duration of action appropriate for twice daily dosing. We believe this pharmacokinetic profile of BIOD-531 to be superior to that of existing products that are marketed as combinations of prandial and basal insulin, namely Humulin® R U-500 and pre-mixed insulins such as Humalog® Mix 75/25. As a result, postprandial glucose has been shown to be better controlled with BIOD-531 after standardized meals. Pre-mixed insulins represent a multi-billion dollar product category that is often used in clinical practice for patients for whom intensive insulin regimens are not practical or appropriate. Because of slow absorption of the prandial component, the use of pre-mixed insulins sacrifice meal-time glucose control. We believe BIOD-531 is well suited to provide real meal time control in this insulin product category."

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