By IANS
Bangalore : Biocon Ltd, India’s leading biotechnology firm, has submitted clinical data of phase-one studies on its oral insulin product (IN-105) to the European Association for Study of Diabetes (EASD) at Amsterdam Friday.
According to a company statement here, the first phase studies were conducted on healthy volunteers after they were administered insulin tablets.
Clinical data on IN-105 was presented at the session on novel therapies. Based on the results, Biocon will develop the molecule through further trials.
“IN-105 is a novel analogue of insulin, proprietary to Biocon. The product has special properties to deliver in tablet form at room temperature,” Biocon chairperson Kiran Mazumdar Shaw said.
Being needle-free, the tablet allows the drug to be administered into the body in a physiological manner that mimics the way the pancreas releases insulin into the circulatory system.
“The data will enable us to bring an oral insulin to diabetic patients the world over. The new drug will be a value differentiator in our quest for global leadership in the insulin segment,” Shaw added.
The firm has carried out trials for the molecule, including clinical development at its manufacturing facility on the outskirts of the city.
Biocon has recently obtained approval from the Swedish medical authorities to carry out phase-one human clamp studies for the molecule in Sweden. It will be the first such clinical trial outside India for its oral insulin.
The Swedish trial will be carried out at the Karolinska Institute clinical research unit.