Advinus develops molecule for diabetes

Advinus Therapeutics, the research-based pharmaceutical company promoted by the Tata Group, on Monday announced the discovery of a novel molecule for the treatment of type II diabetes — GKM 001. The molecule is an activator of glucokinase; an enzyme that regulates glucose balance and insulin secretion in the body.

GKM-001 is an indigenously developed molecule and the initial clinical trials have shown good results for both safety and efficacy, a statement from Advinus said.

“Considering past failures of other companies on this target, our discovery programme primarily focussed on identifying a molecule that would be efficacious without causing hypoglycemia; a side effect associated with most compounds developed for this target. Recently completed Phase I data indicate that Advinus’ GKM - 001 is a liver selective molecule that has overcome the biggest clinical challenge of hypoglycemia. GKM-001 is differentiated from most other GK molecules in development due to this novel mechanism of action,” said Rashmi Barbhaiya, MD & CEO, Advinus Therapeutics.

He further added, “We are very proud that GKM-001 is 100 per cent Indian. Advinus’s discovery team in Pune discovered the molecule and entire preclinical development was carried out at our centre in Bangalore. The IND (Investigational New Drug) application was filed with the DGCI for approval to initiate Clinical trials in India within 34 months of initiation of the discovery programme.”

Subsequent to the approval of the IND, we have completed the Phase 1 Single Ascending Dose study in India within two months.”

Right behind the lead candidate GKM-001, Advinus has a pipeline of back up compounds on the same target. These include several structurally different compounds with diverse potency, unique pharmacology and tissue selectivity. Having discovered the molecule with early indication of wide safety margins, desired efficacy and pharmacokinetic profiles, the company is now seeks to out-license GKM-001 and its discovery portfolio.