Biotechnology major Biocon on Tuesday that said the tests conducted for its experimental oral insulin , IN-105 , have not met their primary end point. However, the company is upbeat on continuing its development with a global partner.
A press release from the company said that initial data analysis of the test showed that IN-105 did not meet its primary end point of lowering HbA1c levels by 0.7%, compared to a placebo. HbA1c is a test that measures the amount of glycated haemoglobin in the blood. Glycated haemoglobin levels indicate the effectiveness of a drug to control blood sugar levels.
Kiran Mazumdar Shaw, MD and chairman of Biocon, said in the release: “Based on these encouraging results, Biocon is committed to continue its global development of IN-105 in partnership with a global pharmaceutical partner for which we plan to initiate partnering discussions.” The company added that post-hoc analyses of self-monitored blood glucose levels in the IN-105 arm and the placebo arm indicated large reductions in pre-meal glucose levels in the placebo arm, which strongly suggested behavioural modification among patients , and which might have affected the primary outcome.
A press release from the company said that initial data analysis of the test showed that IN-105 did not meet its primary end point of lowering HbA1c levels by 0.7%, compared to a placebo. HbA1c is a test that measures the amount of glycated haemoglobin in the blood. Glycated haemoglobin levels indicate the effectiveness of a drug to control blood sugar levels.
Kiran Mazumdar Shaw, MD and chairman of Biocon, said in the release: “Based on these encouraging results, Biocon is committed to continue its global development of IN-105 in partnership with a global pharmaceutical partner for which we plan to initiate partnering discussions.” The company added that post-hoc analyses of self-monitored blood glucose levels in the IN-105 arm and the placebo arm indicated large reductions in pre-meal glucose levels in the placebo arm, which strongly suggested behavioural modification among patients , and which might have affected the primary outcome.
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