Therapy Areas: Diabetes
First Patient Dosed in Phase 1 Clinical Trial of DD01 in Obese Patients with Diabetes and NAFLD
31 March 2021 - - South Korea-based clinical-stage biotechnology company D and D Pharmatech, Inc has dosed the first patient in a Phase 1 clinical trial of DD01 in obese patients with diabetes and non-alcoholic fatty liver disease (NAFLD), the company said.

DD01 offers a potential new approach to the dual agonist treatment strategy via potent stimulation of GLP-1R and more mild stimulation of the glucagon receptor.

Dual agonist strategies are gaining momentum as potential treatments for obesity and NASH.

In preclinical models of obesity, diabetes and NAFLD, DD01 treatment reduced weight and improved blood sugar.

These effects were accompanied by improvements in insulin sensitivity and lipid and fat metabolism, effects expected to provide a potential new treatment for fatty liver diseases like NASH (nonalcoholic steatohepatitis).

The effect of DD01 persisted after cessation of treatment suggesting disease-modifying effects contribute to its efficacy.

While approved GLP-1R agonists provide some benefit in these models, the dual-agonist activity of DD01 provided additional benefits and was more effective when compared on an equivalent dose basis.

The Phase 1 study is a randomized, double-blind, placebo-controlled, single and multiple ascending dose study that is expected to enroll approximately 64 patients in the US.

The trial is designed to assess safety, pharmacokinetics and pharmacodynamic effects of DD01 in subjects with obesity, diabetes and NAFLD.

D and D continues to build comprehensive research programs with academia and its subsidiaries Neuraly and Theraly Fibrosis to identify and develop potential disease modifying drugs that target the origin of the disease involving chronic inflammation and severe fibrosis. DD01 is the result of these collaborative efforts.

DD01 is a proprietary, imbalanced dual agonist of GLP-1 and glucagon receptors with a half-life of 11 days in non-human primates. DD01 is being developed as a potential disease-modifying agent for obesity and liver fatty disease.

Treatment with DD01 caused weight loss, reduced liver fat and improved glucose tolerance in preclinical models of obesity, diabetes and fatty liver.