Biodel Inc. announced that it 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 analogues 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 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 occasion. 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 I study is successful, Biodel now anticipates initiating a phase II study in patients with type 1 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. Biodel recently received initial guidance from the US Food and Drug Administration (FDA) on the design of two pivotal phase III clinical trials.

Based on this guidance, Biodel plans to design the phase II 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 II testing are successful, the company plans to launch phase III pivotal studies required for approval in 2012 rather than its previous guidance of 2013.

“We look forward to obtaining initial clinical data for BIOD-105 and BIOD-107,” said Dr Alan Krasner, chief medical officer of Biodel. “Based on pharmacokinetic data obtained in the diabetic swine model, these formulations appear to be very rapidly absorbed, similar to rates of absorption seen with the previously studied Linjeta formulations. Based on last year's clinical data from related formulations BIOD-102 and BIOD-103, we anticipate improved injection site tolerability with BIOD-105 and BIOD-107. We were very pleased with our end of review meeting with the FDA in which they confirmed study details including the use of Humalog as comparator in future clinical trials. The FDA also confirmed that data from the development program for the new formulations would be classified as a Class 2 resubmission with a 6 month review time.”

“We have identified two new formulations with commercial target product profiles that appear to be superior to any of our previous ultra-rapid-acting human insulin drug candidates,” said Dr Errol De Souza, president and CEO of Biodel. “By achieving our candidate selection milestone and receiving constructive feedback from the FDA during our end of review meeting, we have accelerated the clinical development program of these formulations and plan to initiate phase I clinical testing this month and could initiate phase III testing before the end of 2012.”

Biodel now expects to complete the phase I study and launch phase II testing in the third and fourth calendar quarters of 2011, respectively.

Biodel Inc. focused on the development and commercialization of innovative treatments for diabetes that may be safer, more effective and more convenient for patients.