- Study results demonstrate DD01 was safe and well-tolerated at doses highly effective in reducing fatty liver.

- Following only 4 weeks of treatment, all subjects in high dose group achieved at least a 40% reduction in liver fat with a mean reduction of >50% measured by MRI-PDFF (p < 0.0001 v.s. placebo group).

- DD01 provides a unique balance of GLP-1/Glucagon activity that achieves rapid reductions in liver fat even without the weight loss observed at higher doses, thus offering the potential to treat fatty liver disease independent of the long-term treatment needed to achieve the same effect with an incretin alone.

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 positive topline results from its Phase 1 clinical trial of DD01 in overweight/obese patients with type 2 diabetes (T2D) and non-alcoholic fatty liver disease (NAFLD). DD01 is a long-lasting, dual GLP-1/glucagon receptor agonist designed to rapidly resolve hepatic steatosis, improve glycemic control, and reduce body weight in fatty liver disease with and without co-occurring T2D and obesity.

This trial was a randomized, double-blind, placebo-controlled single ascending dose (SAD) and multiple ascending dose (MAD) studies performed at four clinical sites in the U.S. Eligible participants included T2D who are overweight/obese for SAD study and obese with T2D and NAFLD for MAD study with a minimum body mass index (BMI) of 30 kg/m2 and hepatic fat contents of ≥10% by MRI-PDFF. A total hundred-seven (107) subjects were enrolled, and fifty (50) subjects in the MAD portion were assigned to receive subcutaneous doses of DD01 at up to 80 mg or placebo once weekly for four weeks without dose titration. The trial was designed to assess the safety, pharmacokinetics, and pharmacodynamic effects of DD01.

DD01 was generally safe and well tolerated with gastrointestinal adverse events like those reported for selective GLP-1 receptor agonists. Following only four (4) weeks of once-weekly treatment, up to 100% of patients achieved >30% liver fat reduction by MRI-PDFF. A mean relative reduction in liver fat content of >50% was observed in a pooled analysis of the two high doses of DD01, whereas the change from baseline in placebo-treated subjects was <5%. Rapid improvements in steatosis were observed at well-tolerated doses and accompanied by increased insulin, decreased HbA1c, and weight loss at higher doses. In obese, diabetic subjects with NAFLD, the dual-pathway effect of DD01, acting through both the GLP-1 and glucagon receptor, was apparent and beneficial to these commonly co-morbid conditions. Presentation of clinical data showing the effects of DD01 and preclinical data illustrating highlights of the underlying mechanism of action is planned for upcoming conferences in 2023.

“We are thrilled to receive the positive topline results from this initial trial that show DD01 has strong potential to rapidly reduce fatty liver independent of the longer-term goal of weight loss recommended for some patients. Due to its rapid action and beneficial effects on glucose control, DD01 may provide an effective adjunct to diet and exercise in these patients, uncoupling the need for weight loss to precede improvements in liver health,” said Adam Bell, Ph.D., VP of Translational Medicine and Regulatory Affairs.

“Direct targeting of fatty liver has proven beneficial in NASH patients. A ≥30% reduction in liver fat is associated with a clinically significant improvement in NASH scores. In NAFLD, DD01 achieved and exceeded this level in only 4 weeks,” added Seulki Lee, Ph.D., President, and Chief Executive Officer of D&D Pharmatech. “With these positive results, we look forward to conducting a Phase 2 study to further validate the utility of DD01 in the treatment of NAFLD and NASH both with and without co-occurring obesity and diabetes.”

More information about the study is available at www.clinicaltrials.gov under the identifier NCT04812262.

Clinical Implications

At present, there are no treatments for nonalcoholic fatty liver disease. While both pre-diabetic and diabetic patients routinely present with fatty liver disease, doctors typically recommend weight loss, which can be effective but is slow and, for many patients, proves challenging. DD01 treatment results in rapid and clinically significant reductions in liver fat in only 4 weeks of treatment. One could easily envision using DD01 as an adjunct to diet and exercise to improve liver health rapidly. Patients may achieve rapid reductions in liver fat while benefiting over the long term from improved glycemic control and weight loss.

About DD01

DD01 is a proprietary, long-acting dual agonist of GLP-1 and glucagon receptors with a half-life of 7-8 days in obese/overweight patients with T2D and NAFLD. 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. Treatment with DD01 caused significant weight loss, reduced liver fat, 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 various indications, including neurodegenerative, fibrotic, and metabolic diseases. For more information, please visit http://www.ddpharmatech.com/.

Contacts

Neuraly

Ben Gibson

240-937-5876

[email protected]