Robust and sustained efficacy
- Demonstrated glucose Lowering without hypoglycemia in normal and Type II Diabetes Mellitus (T2DM) subjects in single ascending dose study and in T2DM in a 14 day multiple ascending dose (MAD) study despite an apparent 21 hours half life – early but strong evidence of proof of concept in humans
GKM-001 is a novel Glucokinase activator (GKA) with a liver selective MoA
- Robust fasting and post-prandial glucose lowering achieved without hypoglycemia validating pre-clinical efficacy and safety data – right balance of potency, liver selectivity and PK providing efficacy without hypoglycemia associated with pan GK activators
Superior Safety profile
- Unlike pan active GKAs, GKM-001 appears to have no effect on insulin secretion as evident from in vitro studies and the lack of increase in C-peptide in T2DM patients
- In the MAD study in T2DM patients, no clinically relevant adverse events, changes in vital signs (including blood pressure) and changes in laboratory values were observed including liver enzymes & lipids – triglycerides, cholesterol and non-esterified fatty acids
Ready for long term clinical trial
- 90-day safety studies successfully completed to initiate additional clinical studies including a 12-week Phase IIb (effect on HbA1c) study
Clear IP position
- US, EP Composition of Matter patent granted (US 8501955)