The study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of ALS 2-0426. Designed in two parts, the initial double-blind, placebo controlled phase I clinical study will enroll approximately 50 healthy male volunteers in one center in the US. The first study uses a single, ascending oral dose, sequential cohort design and will be followed by a multiple dose study also in healthy volunteers.
ALS 2-0426 is an orally active, small molecule inhibitor of dipeptidyl peptidase IV (DPP-IV). DPP-IV inhibitors have been clinically shown to provide long-term improvement of glucose control without the risk of hypoglycemia, and to improve the function of pancreatic beta cells, the cells responsible for the production of insulin. DPP-IV inhibitors represent a novel approach to the treatment of type 2 diabetes.
“Based on preclinical studies, we believe ALS 2-0426 offers significant advantages compared to other products being developed today, including superior efficacy and safety, making it best in class among all DPP-IV inhibitors,” said Dr Keith Dionne, CEO of Alantos.