Alantos initiates Phase I study for DPP-IV diabetes drug
compound for diabetes, a disease that commands a global market
estimated at $11bn (€8.6bn) and is expected to grow by more than 50
per cent by the end of the decade.
Currently, there are an estimated 200m people worldwide suffering from diabetes; 90 per cent of which have adult onset, or type II diabetes. In type II diabetes, either the pancreas does not produce sufficient insulin or the body fails to respond properly to insulin.
Alantos' drug candidate, ALS 2-0426, is an orally active, small molecule inhibitor of Dipeptidyl Peptidase IV (DPP-IV), for the treatment of type II diabetes.
DPP-IV inactivates glucagon-like peptide-1 (GLP-1), an important mediator of blood glucose levels following meals and has been clinically shown to provide long term improvement of glucose control without the risk of hypoglycaemia.
The drug is also thought 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. GlaxoSmithKline (GSK) and Merck are just two of the names in big pharma to further investigate the potential of this drug in treating diabetes.
In addition, Biovitrum and Santhera formed a collaboration agreement in August 2005, which aims to develop DPP-IV inhibitors for the treatment of type 2 diabetes and other metabolic diseases.
"DPP-IV inhibitors represent a new class of treatment for diabetes and one that has received much recognition from the pharmaceutical industry," said Keith Dionne, chief executive officer of Alantos.
"Based on pre-clinical studies, we believe ALS 2-0426 offers 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 I clinical study will enrol approximately 50 healthy male volunteers in one centre 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.
The study will evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of ALS 2-0426.
According to the European Association for the Study of Diabetes, (EASD), the DPP IV inhibitors are among the more promising new therapies in the pipeline for the treatment of type 2 diabetes, which currently affects 37m people in the top seven markets and is expected to grow to 50m people by 2012.