The country's biotech major Biocon Ltd has presented the results of phase I studies on its oral insulin product, IN-105 at the European Association for Study of Diabetes (EASD) meeting held at Amsterdam on September 21, 2007.
Phase I studies were conducted on healthy volunteers who have been administered IN-105 in the form of a tablet. The human clinical data on IN-105 was presented at the session on Novel therapies. Based on these promising results, the company intends to now develop this molecule through further clinical trials.
IN-105 is a novel analog of insulin, proprietary to the company. 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 a 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.
Kiran Mazumdar Shaw, CMD, of the company said, "This is indeed an encouraging step towards our efforts of bringing an oral insulin to diabetic patients across the world. IN-105 promises to be a significant value differentiator in Biocon's quest for global leadership in the insulin segment".
The company has carried out all of the developments for this molecule, including clinical development at its facilities in Bangalore, India. It has also recently obtained approval from the Swedish medical authorities to carry out phase I human clamp studies for this molecule in Sweden. This will be the first such clinical trial outside of India for IN-105. The Swedish trial will be carried out at the Karolinska Institute clinical research unit and will be focused on obtaining more pharmacological understanding of the mode of action of IN-105.