Avesthagen, India's leading knowledge-based systems biology company, has commenced phase III clinical trials for its recently launched Avesta brand of botanical bioActives.
The company and Manipal AcuNova Limited, Bangalore have a strategic agreement for conducting the studies for diabetes management for Avesthagen's branded bioActives Teestar, Aspand and Cincata. These products have been developed by the bionutrition division of Avesthagen Ltd 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 Teestar was evaluated in pre-clinical studies wherein it showed significant reduction of blood glucose levels.
Aspand acts by inhibiting Dipeptidyl peptidase IV and by sensitising insulin. Aspand 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. Cincata 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.
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.
According to Dr Villoo Morawala Patell, founder, chairperson and MD of Avesthagen, the initiation of this phase III human trial represents an important strategic milestone for Avesthagen 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," she added.