Biodel Inc., a specialty biopharmaceutical company focused on developing treatments for diabetes, today announced it has chosen two new formulations of recombinant human insulin for clinical testing and that it is accelerating clinical development plans for the drug candidates.
The new formulations, BIOD-105 and BIOD-107, are designed to generate a faster insulin action compared to currently marketed insulin analogs while at the same time maintaining an injection site tolerability profile comparable to currently marketed insulins.
Biodel plans to commence a phase 1 clinical trial of approximately 18 patients with Type 1 diabetes, expected to be completed in the third calendar quarter of 2011, to evaluate pharmacokinetic, pharmacodynamic and tolerability profiles of the two experimental insulins relative to that of Humalog®.
Contingent on the success of the phase 1 study, Biodel will initiate a phase 2 study in patients with Type 1 diabetes in the fourth calendar quarter of 2011, which would include two separate pivotal trials– one in patients with Type 1 diabetes, and the other in patients with Type 2 diabetes.
The company recently received initial guidance from the U.S. Food and Drug Administration (FDA) on the design of two pivotal phase 3 clinical trials. If the results of the phase 2 testing are successful, the company said it plans to launch phase 3 pivotal studies required for approval in 2012 rather than its previous guidance of 2013.
Dr. Alan Krasner, chief medical officer of Biodel, said that based on pharmacokinetic data obtained in the diabetic swine model, BIOD-105 and BIOD-107 appear to be rapidly absorbed and that the company anticipates improved injection site tolerability.
“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,” Dr. Errol De Souza, president and CEO of Biodel stated in the press release. “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 1 clinical testing this month and could initiate phase 3 testing before the end of 2012.”
For more information visit www.biodel.com