DANBURY, Conn. — A drug maker focused on development and commercialization of diabetes treatments unveiled its accelerating clinical development plans of two drug candidates.
Biodel said BIOD-105 and BIOD-107, known as ultra rapid-acting insulins, are designed to result in more rapid insulin action, compared with currently marketed mealtime insulin analogs.
The company said it is initiating a phase-1 trial in third quarter 2011, which will examine the efficacy of the drugs in Type 1 diabetes patients, and will be followed by a phase-2 trial in fourth quarter 2011 if the initial phase is successful. The phase-2 study is intended to follow the same overall design that would be implemented in phase-3 studies, which would commence in 2012 and include two separate pivotal trials — one in patients with Type 1 diabetes and the other in patients with Type 2 diabetes.
Biodel said it recently received initial guidance from the Food and Drug Administration on the design of two pivotal phase-3 clinical trials. "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 Errol De Souza, president and CEO of Biodel. "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."