Danbury biopharma Biodel Inc. is launching a Phase 2 trial of its super fast-acting form of insulin meant to be taken at mealtime, officials say.
“We are pleased to achieve another milestone in the development of BIOD-123,’’ said CEO Errol DeSouza. “We continue to meet our timelines and project that we will be able to communicate top-line Phase 2 safety and efficacy data in the third calendar quarter of 2013.”
Last April, Biodel said the Phase 1 trial of BIOD-123 showed its formulation had a faster absorption rate into test-patients’ bloodstreams than insulin lispro, sold as Humalog.
The Phase 2 study is a randomized, open label parallel group study enrolling 130 patients with Type 1 diabetes at approximately 30 U.S. investigative centers.
The patients are randomized to receive either BIOD-123 or insulin lispro as their mealtime insulin over an 18-week treatment duration.
