Biodel Inc. has selected two new formulations of recombinant human insulin for clinical testing and is accelerating clinical development plans of these mealtime insulin drug candidates.
The new formulations, BIOD-105 and BIOD-107, are designed to result in more rapid insulin action compared to currently marketed meal time insulin analogs while maintaining an injection site tolerability profile comparable to currently marketed insulins. Biodel plans to test these formulations in a Phase 1 clinical trial of approximately 18 patients with type 1 diabetes. This study is designed as a double blinded, three-period cross over trial in which patients will receive one subcutaneous injection of BIOD-105, BIOD-107 and Humalog® each on separate occasions. This study, expected to be completed in the third calendar quarter of 2011, will evaluate pharmacokinetic, pharmacodynamic and tolerability profiles of the two experimental insulins relative to that of Humalog®. In parallel with this subcutaneous injection study, Biodel plans to utilize a similar design to conduct a clinical pump study this year.
If this Phase 1 study is successful, Biodel anticipates initiating a Phase 2 study in patients with type 1 diabetes in the fourth calendar quarter of 2011. The Phase 2 study is intended to follow the same overall design that would be implemented in Phase 3 studies, which would include two separate pivotal trials– one in patients with type 1 diabetes, and the other in patients with type 2 diabetes.
Biodel recently received initial guidance from the U.S. Food and Drug Administration (FDA) on the design of two pivotal Phase 3 clinical trials. Based on this guidance, Biodel plans to design the Phase 2 and 3 studies as randomized parallel group studies using Humalog® as a comparator in which active dose titration will occur in the first two months after randomization followed by three months of relatively stable dosing. In these studies, Biodel plans to evaluate efficacy using HbA1c as well as measures of postprandial glucose profiles. If the results of the Phase 2 testing are successful, the company plans to launch Phase 3 pivotal studies required for approval in 2012 rather than its previous guidance of 2013.