New Delhi: Biotechnology major Biocon on Thursday said it has received financial support from the US-based JDRF for a global clinical study of its oral insulin drug candidate Insulin Tregopil.
The study will be focussed on patients with type 1 diabetes (T1D), an autoimmune condition in which the body’s immune system is activated to destroy insulin producing cells in the pancreas.
“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,” Biocon CMD Kiran Mazumdar-Shaw said in a statement.
JDRF is a leading global organization funding T1D research and advocacy worldwide.
Biocon, however, did not share details about the quantum of financial support it will receive from JDRF.
Tregopil, a first-in-class oral insulin molecule being developed by Biocon, is one of the most advanced programs in the global oral insulin space.
The fast-acting oral insulin could improve postprandial glucose control with reduced side effects and greater adherence, thus holding the promise to transform T1D management.
“We believe Tregopil can make a significant difference to the diabetes management paradigm for both type 1 and type 2 diabetes and welcome JDRF’s support in advancing this unique oral insulin molecule through the clinic for type 1 diabetes,” Mazumdar-Shaw said.
The Bengaluru-based firm proposes to conduct an open label study to evaluate the pharmacokinetics (PK), pharmacodynamics (PD), safety and tolerability of multiple ascending doses of Tregopil.
It also plans to compare the PK, PD, and safety of the optimal dose regimen of Tregopil with therapeutic doses of Insulin Aspart in individuals with T1D.
JDRF through its Industry Discovery and Development Partnership (IDDP) program provides financial support to accelerate breakthrough research in T1D management.
Globally, around 422 million adults were living with diabetes in 2014.