The Chennai-based pharma major, Orchid Chemicals’ US drug discovery joint venture company, Bexel Pharmaceuticals, would be soon starting human trials on its novel anti-diabetic molecule BLX 1002. The company, which has been working on this molecule, has already received approval from the Independent Ethics Committee (IEC) in Europe for conducting Phase I human clinical trials. According to company sources, the molecule has been proved safe and efficacious in the pre-clinical studies.
BLX-1002 is an orally active small molecule for treatment of Type-2 diabetes. The molecule is distinctive in its class for not only its exceptional efficacy and safety, but also its unique anti-weight-gain property. The molecule recently completed safety toxicity pre-clinical studies in the US both in small order animals like rodents and higher order animals like dogs. The Phase I human clinical study of the molecule, which will be initiated in Europe from December 15, 2003, is scheduled to end by April 2004. The Phase I clinical trials will be followed by Phase II (a) proof-of-concept study in Europe.
According to company sources, the molecule was also showcased with regard to its efficacy and safety at recent international conferences like International Diabetes Association (IDA) and American Diabetes Association (ADA), which evoked considerable interest.
Orchid sources said that the pre-clinical results of the molecule are very promising and it is the only diabetes molecule in its class with anti-weight gain properties. “As we are convinced that the molecule would offer a break-through therapy given its distinctive properties it is our intention to build value by licensing the molecule only after Phase II (a) studies, ” they added.