Biopharmceutical firm Biocon on Wednesday said it got funding from US-based charity JDRF to test its oral insulin candidate Tregopil on type 1 diabetes patients.
“This collaboration with Biocon is a part of JDRF’s Industry Discovery and Development Partnership (IDDP) programme, through which JDRF provides financial support to accelerate breakthrough research in T1D management,” Biocon said in a statement.
Biocon didn’t disclose the quantum of funding.
As per the agreement – JDRF or Juvenile Diabetes Research Foundation as it was known, will fund Biocon’s global multiple ascending dose study of oral insulin drug candidate to evaluate the safety and tolerability in people with type 1 diabetes.
“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,”said Kiran Mazumdar-Shaw, CMD, Biocon.
“We are committed to addressing the huge unmet need of people with diabetes by providing the medical community an alternate treatment for postprandial hyperglycaemia,”Mazumdar-Shaw said.
JDRF has so far contributed more than USD 2 billion to type 1 diabetes research. The charity founded in New York in 1970 by a group of local parents of children with type-1 diabetes to mobilise and raise money for diabetes research, is currently funding 50 human clinical trials of potential type-1 diabetes therapies.
Biocon has developed new formulation of insulin to be delivered through a pill instead of an injection as it is taken now. Insulin delivered through a pill is considered more convenient, safe and effective; however, the success has been elusive so far as insulin rapidly degrades in the stomach and the upper portion of the small intestine, making it almost impossible to deliver orally.
Danish company Novo Nordisk withdrew from oral insulin citing commercial viability last year.
Biocon had announced positive clinical data in 2016 for Insulin Tregopil following a set of Phase I studies conducted in the US, which established the drug’s important role in postprandial glycaemic control. One of the studies demonstrated the 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.
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 US are expected to have T1D by 2050.