Alantos Pharmaceuticals initiates phase 1 clinical studies with lead compound for type II diabetes
"The initiation of this clinical trial marks a significant milestone for Alantos as we transition our internal research into product development," said Keith Dionne, Ph.D., Chief Executive Officer of Alantos. "DPP-IV inhibitors represent a new class of treatment for diabetes and one that has received much recognition from the pharmaceutical industry. Based on pre-clinical 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."
Designed in two parts, the initial double-blind, placebo controlled Phase 1 clinical study will enroll approximately 50 healthy male volunteers in one center in the U.S. 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. The study will evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of ALS 2-0426.
DPP-IV inactivates glucagon-like peptide-1 (GLP-1), an important mediator of blood glucose levels following meals. 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 II diabetes.
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