New fixed-dose combination diabetes drug to undergo human clinical trials

The first human trials have begun of a fixed-dose combination drug of human insulin and pramlintide to help treat type 1 diabetes.
The drug is called BioChaperone Pramlintide, developed by biotechnology company Adocia, which aims to improve blood glucose levels following meals.
It combines Symlin (pramlintide), a synthetic version of the natural hormone amylin which can help improve postprandial blood sugars, and Adocia’s BioChaperone technology, which helps to optimise the performance of drugs.
While insulin regulates glucose levels, amylin helps to suppress glucagon, but as type 1 diabetes progresses neither hormone is eventually secreted. By combining human insulin and the synthetic pramlintide drug, researchers hope to mimic the way amylin and insulin are secreted from pancreatic beta cells.
Researchers also hope to fully realise the potential of Symli, the only FDA-approved amylin analog drug to be used alongside insulin, which is not approved in the UK by the NHS.
While Symlin has helped improve HbA1c and induce weight loss in people with type 1 diabetes and type 2 diabetes when added to insulin therapy, patient adherence to both insulin and Symlin has shown to be poor.
Adocia’s BioChaperone technology will be directed to increase the effectiveness of pramlintide, making it easier to use for patients.
“By removing the adherence barrier presented by additional injections, we hope to fully realize the therapeutic potential of pramlintide for people with type 1 diabetes,” said Dr. Stan Glezer, Adocia’s Chief Medical Officer.
In this new trial, 24 people with type 1 diabetes will be randomly assigned to BioChaperone Pramlintide in sequence with two other treatments, with safety, tolerance and blood glucose levels after meals among the primary objectives.
The study is expected to be completed towards the end of 2018.