Biodel 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 I clinical trial of approximately 18 patients with Type I 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 HumalogR each on separate occasions. This study, expected to be completed in the third quarter of 2011, will evaluate pharmacokinetic, pharmacodynamic and tolerability profiles of the two experimental insulins relative to that of HumalogR.
If this phase I study is successful, Biodel anticipates initiating a phase II study in patients with Type I diabetes in the fourth calendar quarter of 2011. The phase II study is intended to follow the same overall design that would be implemented in phase III studies, which would include two separate pivotal trials—one in patients with Type I diabetes, and the other in patients with Type II diabetes.
If the results of the phase II testing are successful, the company plans to launch phase III pivotal studies in 2012.