Biocon, JDRF to conduct global study on oral insulin

Biocon and JDRF, a leading global organisation funding Type 1 diabetes (T1D) research and advocacy worldwide, announced a partnership to support a global study with an oral insulin drug candidate, Insulin Tregopil, in people with T1D, according to a statement on Wednesday.

Insulin Tregopil, an oral insulin molecule being developed by Biocon, is one of the advanced programmes in the global oral insulin space. The fast-acting oral insulin could improve post-prandial glucose control with reduced side effects and greater adherence, thus holding a promise to transform T1D management.

Biocon proposes to conduct an open label study to evaluate the doses of Insulin Tregopil and compare it with therapeutic doses of Insulin Aspart in individuals with T1D.

Globally, an estimated 422 million adults were living with diabetes in 2014. While separate global estimates of diabetes prevalence for Type 1 and Type 2 do not exist, it is estimated that 1.25 million Americans are living with T1D. Five million people in the U.S. are expected to have T1D by 2050.

The collaboration with Biocon is a part of JDRF's Industry Discovery and Development Partnership (IDDP) programme, through which the latter provides financial support to accelerate breakthrough research in T1D management, according to the statement.

“With this proposed clinical study, we hope to build on the extremely promising data that we have generated so far through previous human trials with Tregopil,” Kiran Mazumdar-Shaw, CMD, Biocon said in a statement.

Biocon had announced positive clinical data in 2016 for Insulin Tregopil following a set of Phase I studies conducted in the U.S., which established the drug's important role in postprandial glycaemic control.

One of the studies demonstrated fast action of Insulin Tregopil with distinctive properties compared to other prandial insulins.

Based on the positive data sets, Biocon has decided to advance this research asset through clinical trials for validation in a larger patient cohort. The company has also filed a Clinical Trial Application with the Indian regulator (DCGI) for a Phase II/III study with Insulin Tregopil in Type 2 diabetes.

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Printable version | Jul 15, 2020 3:42:32 AM |

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