Avesthagen, a Bangalore-based systems biology company, has announced the start of phase III human clinical trials for its 'Avestaa' brand of botanical bioactives. |
The company has signed an agreement with Bangalore-based clinical research organisation, Manipal AcuNova, to conduct the Phase III human clinical studies for diabetes management for branded bioactives Teestar, Aspand and Cincata. |
These bioactives have been developed by the bionutrition division of Avesthagen from different medicinal plants selected from its proprietary database "" ADePt, and validated using MetaGrid, its patented comprehensive constituent profiling technology. |
Teestar acts by intervening with carbohydrate metabolism. The efficacy of this was evaluated in pre-clinical studies wherein it showed a significant reduction in blood-glucose levels. |
Aspand acts by inhibiting dipeptidyl peptidase IV and by sensitising insulin. The bioactive was tested on different cell lines in-house in different assays, where Aspand treated group showed inhibition of Dipeptidyl peptidase IV and better glucose homeostasis as compared to the control. |
Cincata acts by inhibiting a-glucosidase and by acting synergistically with insulin, thereby increasing its potency. This was tested on different cell lines in-house in different assays, where Cincata treated group showed inhibition of a-glucosidase, and better glucose homeostasis as compared to the control, the company said. |
During pre-clinical studies, all three bioactives recorded a significant decrease in blood sugar levels in diabetic animal models and also recorded a significant reduction in the level of glycated haemoglobin HbA1c in comparison to the controls. |
Speaking on the launch, Villoo Morawala Patell, founder, chairperson and MD of Avesthagen, said, "The initiation of this Phase III human trial represents an important strategic milestone for us because it demonstrates the continued advancement of our product portfolio of novel therapeutics for wide spread diseases. We are pursuing aggressively the Phase III clinical development of these bioActives to establish the parameters of the clinical trial design that can lead to regulatory approval." |