JD Bioscience to go all-out for fatty liver disease treatment

Kim Ha-il, founder of JD Bioscience and professor from the Graduate School of Medical Science and Engineering at the Korea Advanced Institute of Science and Technology (KAIST)

South Korean drug developer JD Bioscience Inc. will accelerate the development of the world’s first Korean drug to treat fatty liver disease.

“About one-third of the Korean population has a fatty liver, which is a cause of liver cancer,” Kim Ha-il, founder of JD Bioscience and professor from the Graduate School of Medical Science and Engineering at the Korea Advanced Institute of Science and Technology (KAIST), said. “We aim for our novel drug GM-60106 to become a first-in-class fatty liver treatment.”

Kim’s remarks were made during a recent interview with Maeil Business Newspaper.

He noted that targeting liver fibrosis of the liver and metabolic dysfunction-associated steatohepatitis (MASH), which are considered pre-disease stage domestically, can help prevent MASH and liver cancer.

The statement reflects the ambition to create the world’s first innovative Korean drug in a situation where an optimal fatty liver treatment is currently not available anywhere in the world.

Fatty liver is a condition where more than 5 percent of fat accumulates in liver cells, and most liver diseases can be traced to a fatty liver and GM-60106 targets this starting point. The drug inhibits the HTR2A protein, expressed on the surface of liver cells and hepatocytes, which accelerates fat accumulation in the liver.

JD Bioscience confirmed in preclinical animal tests that the candidate substance of the novel drug inhibits up to 70 percent of fat accumulation in the liver, and a Phase 1 clinical trial involving 88 healthy adults in Australia is currently underway.

Kim noted that the Phase 1 clinical trial has been “very successful as it confirmed GM-60106’s safety and efficacy.”

“We plan to proceed with a Phase 1 clinical trial in the United States after concluding this Phase 1 trial in March 2024,” the founder said.

The U.S. Food and Drug Administration is also expected to decide on the approval of Madrigal Pharmaceuticals Inc.’s metabolic-associated steatohepatitis (MASH) treatment Resmetirom in March 2024, with Resmetirom on track to become the world’s first treatment for the disease.

Kim highlighted how GM-60106 is differentiated from Madrigal Pharmaceutical’s offering, stating, “Resmetirom is a drug that inhibits fat accumulation in the liver, but it does not directly treat liver fibrosis.”

“GM-60106 not only has preventive effects on fat accumulation in the liver but also shows direct therapeutic effects on liver fibrosis, making it distinct from other competing drugs,” Kim said.

GM-60106 has been shown to inhibit liver fibrosis by 70 percent in tests, while the treatment mechanism is also differentiated. Resmetirom primarily promotes the metabolism of fat throughout the body, while GM-60106 inhibits fat accumulation in liver cells. GM-60106 also minimizes blood and brain barrier permeability, minimizing central nervous system side effects such as suicidal impulses.

JD Bioscience’s goals for 2024 include a technology export and beginning Phase 2 clinical trials.

The drug developer noted that it is in negotiations with a U.S. company for technology export and is looking for a global cooperation partner for its Phase 1 clinical trials in the United States. The company is also planning an initial public offering to secure clinical funds.

According to market research firm Future Market Insights, the global fatty liver treatment market is projected to reach $32.5 billion by 2032.