Bangalore, September 08, 2008
The results indicate that IN-105 is safe and well tolerated by Type 2 diabetic patients and is able to significantly drop 2-hour post prandial glucose in a dose-related manner.
Biocon Limited, India's premier biotechnology company, announced the results of an ascending dose study with their oral insulin drug (IN-105) at the European Association for the Study of Diabetes (EASD) meeting in Rome on September 8, 2008. The study involved dosing Type 2 diabetes subjects with single doses of 0 mg (placebo), 10 mg, 15 mg, 20 mg and 30 mg tablets of IN-105 in 5 separate periods before a mixed 600 kcal breakfast. The outcome measurements were the safety and tolerability of IN-105, as well as the pharmacokinetics and pharmacodynamics of IN-105. The results showed that IN-105 was safe and well tolerated by patients.
Absorption of IN-105 was proportional to the dose administered; a serum average Cmax of 350 milliunits /litre was reached at 30 minutes post dosing at the highest dose of 30 mg. The resulting glucose drops showed linearity with respect to the dose. The 2 hour postprandial glucose rise over baseline for the 10, 15, 20 and 30 mg doses were 15.3, 24.1, 31.3 and 49.5 mg/dL lower than the corresponding rise for placebo. There were no symptomatic hypoglycemic events observed at any of the doses. Due to the rapid pharmacokinetics of the drug, there were transient values of hypoglycemia seen soon after the administration of the drug; however these values did not result in any symptoms due to the rapid alleviation of glucose levels due to the meal that followed the drug. C-peptide values were also significantly depressed over all the doses tested, indicating a possibility of beta cell rest in patients dosed with IN-105. Longer term, 6 month, studies are being planned in Type 2 diabetic subjects to understand the impact of chronic dosing of IN-105 on postprandial glucose control and glycated haemoglobin.
"The present study shows that IN105 delivers physiologically active insulin orally in concentrations sufficient to decrease post-meal hyperglycemia and to decrease the burden of the meal on endogenous insulin secretion. These data support the feasibility of providing insulin orally to treat postprandial hyperglycemia in diabetic patients" affirmed Dr Harold E Lebovitz, M.D, FACE, Professor of Medicine, Endocrinology and Diabetes State University of New York Health Science Center at Brooklyn
"The data presented here show that insulin can be reliably delivered in individuals with type 2 diabetes via the oral route. Further the administered insulin improved control post meal plasma glucose without causing symptomatic hypoglycemia. Such data support the feasibility of oral insulin delivery as a therapeutic option" said Prof Alan D. Cherrington, Ph.D. Professor of Molecular Physiology & Biophysics, Professor of Medicine, Vanderbilt University.
IN-105 is a novel analog of insulin, proprietary to Biocon. The product has special properties that make it feasible for delivery in tablet form stable at room temperature. The advantages of tablet delivery go beyond the obvious. Besides being needle-free insulin, this method of delivery allows IN-105 to be delivered into the body in a physiological manner that mimics the way that the pancreas release insulin into the circulation (i.e. into the portal vein). This contrasts with all the other known methods of delivery, including inhaled insulin, which brings in insulin from the periphery into the circulation.
About Biocon Limited
Biocon Limited is India’s pioneer biotechnology enterprise established in 1978. Biocon and its two subsidiaries, Syngene and Clinigene form a fully integrated biotechnology enterprise, with specialized focus on biopharmaceuticals, contract research and clinical research. Strategic international acquisitions, such as acquiring a majority in the German pharmaceutical company, AxiCorp, have given Biocon wider global access and greater market penetration. Many of our products have USFDA and EMEA acceptance.
Biocon's proprietary technologies have been used effectively in diabetology, oncology, cardiology, nephrology and other therapeutic treatments. The company's robust drug discovery pipeline offers novel therapies on a platform of affordable innovation. Biocon launched the world's first recombinant human insulin, INSUGEN® in November 2004 using Pichia expression and India's first indigenously produced monoclonal antibody BIOMAb-EGFR™ in September 2006.
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