Biocon Ltd. announced key data on Insulin Tregopil (formerly referred to as IN-105) following Phase 1 studies that validate and provide the basis for the next phase of clinical development of this important molecule. The clinical studies on Insulin Tregopil, which were conducted in the US under a US IND, were initiated in partnership with Bristol-Myers Squibb (BMS) prior to their divestment of the diabetes franchise to AstraZeneca. Following are the key research outcomes of the Phase 1 study conducted in the US: A major technological achievement was the development of a unique and specific assay for measuring Insulin Tregopil.

This assay accurately differentiates between endogenous insulin and Insulin Tregopil in human plasma and thereby enables the assessment of pharmacokinetic effects of Insulin Tregopil. A drug-drug interaction study of Insulin Tregopil and metformin shows that metformin does not affect the efficacy of Insulin Tregopil. Food effect studies using the specific assay for Insulin Tregopil showed that high carbohydrate, high protein and high fat diets do not affect the efficacy of Insulin Tregopil.

Dosing studies conducted with meals show that there is a clear linear relationship between the dose of administered Insulin Tregopil and the decrease in postprandial glucose excursion rates. Comparing orally administered Insulin Tregopil to injected Insulin Aspart shows that the effect of Insulin Tregopil occurs considerably more rapidly than Insulin Aspart, and is significantly shorter in duration of action than Insulin Aspart Consequently, Insulin Tregopil has the potential for more rapid insulinization of the liver and a significantly lower propensity to cause postprandial hypoglycemia than Insulin Aspart.