- The Fast Track designation accelerates DD01’s path to U.S. FDA submission for the treatment of adults with MASLD/MASH

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, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the investigation of DD01 for the treatment of adults with non-alcoholic steatohepatitis (NASH), also known as metabolic dysfunction-associated steatohepatitis (MASH). FDA Fast Track designation is intended to bring promising drugs to patients sooner by facilitating the development and expediting the review of drugs that fulfill unmet needs in serious diseases.

The FDA based its decision on data from Phase 1, a randomized, double-blind, placebo-controlled study assessing the safety and efficacy of DD01 in overweight/obese subjects with type 2 diabetes (T2D) and metabolic dysfunction-associated fatty liver disease (MAFLD). In that study, DD01 treatment was well tolerated and reduced hepatic steatosis by >50% in only 4 weeks with up to 100% of subjects achieving ≥30% liver fat reduction by MRI-PDFF. In animal models, DD01 treatment reduced hepatic steatosis, lobular inflammation, ballooning, and signs of fibrosis, all key diagnostic criteria MASH. Weight loss and improved glycemic control were also observed. For many patients, co-occurring type 2 diabetes and obesity are underlying factors. Preclinical and clinical results suggest DD01 treatment may be beneficial in the treatment of fatty liver disease and can improve glycemic control and weight loss in subjects who are overweight or have type 2 diabetes.

“We are pleased with the FDA’s decision to grant Fast Track designation for DD01 and look forward to initiating a Phase 2 study in biopsy-confirmed MASH patients,” said Seulki Lee, Ph.D., CEO of D&D. “MASH has a significant unmet need. Multiple clinical trials have recently proven that efficiently reducing excessive liver fat content leads to ameliorating MASH and liver scarring. DD01 provides rapid reductions in liver fat and beneficial effects on glucose control; thus, we anticipate further studying DD01 in biopsy-confirmed MASH patients after prolonged treatment in an upcoming Phase 2.”

About DD01

DD01 is a proprietary, once-weekly dual agonist of GLP-1 (glucagon-like peptide-1) and glucagon receptors with a half-life of 7-8 days in obese/overweight patients with T2D and MAFLD. A key differentiator for DD01 lies in its dual pathway mechanism of action. Unlike other single and dual agonists, which act only through the incretin pathway, DD01 augments the benefits of incretin therapy acting through the glucagon receptor and enhancing liver lipolysis, leading to rapid effectiveness and the potential to treat the liver first. DD01 treatment results in rapid and clinically significant reductions in liver fat in only 4 weeks of treatment from MAFLD patients. In preclinical studies, DD01 caused significant weight loss, reduced liver fat and fibrosis, and improved glucose tolerance in various preclinical models of obesity, diabetes, and fatty liver, including non-human primates.

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 the translation of cutting-edge research into lifesaving therapeutic products for patients. The company’s product pipeline focuses on metabolic diseases, including obesity, MASH and fibrosis, and neurodegenerative diseases. For more information, please visit http://www.ddpharmatech.com/.

Neuraly Inc. is a wholly owned US subsidiary of D&D Pharmatech.

Contacts

Neuraly Inc.

Ben Gibson

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