GYEONGGI-DO, South Korea & GAITHERSBURG, Md.–(BUSINESS WIRE)–D&D Pharmatech, Inc. (D&D), a clinical-stage biotechnology company focused on the development of disease-modifying drugs, today announced dosing of the first patient in a Phase 1 clinical trial of DD01 in obese patients with diabetes and non-alcoholic fatty liver disease (NAFLD).
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.
“DD01 is long-acting and will be evaluated in patients after administration as a single dose and then once-weekly for four weeks,” said Viktor Roschke, Ph.D., Chief Scientific Officer of Neuraly, a subsidiary of D&D Pharmatech. “With weekly administration, DD01 should provide sustained exposure and mild peak-to-trough ratio – attributes which differentiate it in the field and may help to minimize side effects. DD01 has pharmacologic activity that offers the potential to provide benefits in obesity, type 2 diabetes and in fatty liver diseases like NAFLD and NASH. Our first-in-human study is designed to assess these effects in patients receiving up to a month of treatment.”
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.
“There is a significant need for a safe and effective treatment for obesity and fatty liver diseases including NAFLD and NASH,” said Seulki Lee, Ph.D. CEO of D&D Pharmatech. “NASH is an advanced form of NAFLD which is often accompanied by obesity and diabetes. In patients with NASH, tissue inflammation and liver cell damage are well underway and ultimately leads to liver fibrosis. Currently, there are no effective treatments.”
D&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.
More information about the study is available at www.clinicaltrials.gov under the identifier NCT04812262.
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.
About D&D Pharmatech
D&D Pharmatech is a clinical-stage global biotech company that funds the development of revolutionary medicines through disease-specific subsidiary companies founded and guided by top-tier medical research faculty. This corporate structure creates a unique opportunity to accelerate translation of cutting-edge research into lifesaving therapeutic products for patients. The company’s product pipeline focuses on a range of indications including neurodegenerative, fibrotic and metabolic diseases. D&D Pharmatech is the parent company of U.S.-based Neuraly Inc., Theraly Fibrosis Inc., Precision Molecular Inc., Valted Seq, Inc. and P4 Microbiome, Inc. For more information, please visit http://www.ddpharmatech.com/.