South Korean Biotech's GLP-1 Drug Shows Promise in MASH Treatment with Added Weight Loss Benefits

D&D Pharmatech, a South Korean biotechnology company, has reported positive results from a clinical trial of its dual GLP-1/glucagon receptor agonist, DD01, in patients with metabolic dysfunction-associated steatohepatitis (MASH). The study demonstrates significant reductions in liver fat and notable weight loss effects, potentially positioning DD01 as a promising candidate in the competitive landscape of MASH treatments.

Impressive Liver Fat Reduction

In a 12-week study involving 67 overweight or obese patients with MASH, DD01 demonstrated remarkable efficacy in reducing liver fat content. The trial's primary endpoint was met, with 75.8% of patients receiving DD01 experiencing a more than 30% reduction in liver fat, compared to only 11.8% in the placebo group.

Secondary endpoints were equally impressive, with 72.7% of DD01-treated patients achieving a more than 50% reduction in liver fat, versus 5.9% in the placebo group. Even more striking, 57.6% of patients on DD01 saw their liver fat decrease by more than 70%, while no patients in the placebo group reached this threshold.

Weight Loss Benefits and Tolerability

Beyond its effects on liver fat, DD01 showed promising results in weight reduction. According to D&D Pharmatech, 42.4% of patients treated with DD01 experienced a greater than 5% reduction in body weight. In contrast, the placebo group showed no significant weight loss.

The drug's safety profile appears manageable, with gastrointestinal side effects leading to treatment discontinuation in only three patients. The company reported that these side effects were generally mild to moderate, transient, and manageable.

Competitive Landscape in MASH Treatment

DD01's performance in this trial positions it alongside other promising GLP-1-based therapies in development for MASH. Notable competitors include Novo Nordisk's semaglutide, which is currently awaiting FDA approval for MASH treatment, as well as Eli Lilly's tirzepatide and Boehringer Ingelheim's survodutide.

Dr. Seulki Lee, CEO of D&D Pharmatech, expressed enthusiasm about the results, stating, "The magnitude of improvements is equivalent to what has been achieved only after longer-term treatment with FGF and GLP-1 based drugs already validated with histology data in MASH." Lee emphasized the potential of DD01 to provide a MASH treatment that is easy to manage, encourages weight loss, and is diabetes-friendly.

As the pharmaceutical industry continues to search for effective treatments for MASH, DD01's early success marks a significant development in this challenging therapeutic area. The combination of liver fat reduction, weight loss benefits, and a favorable tolerability profile positions DD01 as a promising candidate for further clinical development in the treatment of MASH.