Korean pharmaceutical and biotech corporations will unveil research results on treatments for liver disease at the European Association for the Study of the Liver, to be held in Spain from the 27th to the 30th. The European Association for the Study of the Liver is considered, along with the American Association for the Study of Liver Diseases, one of the two major overseas societies. It can be a venue to glean the latest research trends, make an impression on global drugmakers, and discuss technology transfer.
At this year's meeting, there will be active discussion on metabolic dysfunction–associated steatohepatitis (MASH), commonly called fatty liver. It occurs when excess fat accumulates in the liver and causes inflammation, which can lead to hepatitis, cirrhosis, and liver cancer. It can develop even without alcohol consumption. Corporations are pushing beyond simple fat reduction to tackle improvement in fibrosis, in which the liver hardens.
◇ Fat reduced and fibrosis improved…a push to conquer MASH
D&D Pharmatech will disclose key phase 2 endpoints for DD01, a MASH drug candidate. It plans to present biopsy results showing how much liver fibrosis improved at week 48 of patient dosing. Earlier, at week 12 of dosing, liver fat decreased by an average of 62.3%. If inflammation persists due to fatty liver, tissue can become fibrotic and harden.
This candidate is a once‑weekly injectable that acts on the glucagon‑like peptide‑1 (GLP‑1) and glucagon receptors. GLP‑1 is a hormone that promotes insulin secretion in the pancreas. While it is mainly used as an obesity treatment, its efficacy in MASH has recently been demonstrated, spurring active development of new drugs using it.
D&D Pharmatech will advance development of its MASH therapy through phase 2. From phase 3, it will pursue a license‑out (technology transfer). Because taking phase 2 forward directly requires enormous expense and time, the plan is to pursue technology transfer.
◇ A makeover for obesity drugs? Potential for liver treatment as well
Metabia, an affiliate of Dong-A ST, will present study results on DA-1726, an obesity treatment candidate. Likewise, it acts simultaneously on GLP‑1 and glucagon receptors. It is known to suppress appetite and increase basal metabolic rate in the periphery, inducing weight loss.
This candidate is confirming efficacy and safety in a phase 1 trial. By day 54 of treatment, weight loss was observed along with a 10.3% reduction in liver stiffness relative to baseline. A decrease in stiffness is regarded as an indicator that can be linked to improvement in liver fibrosis.
A company official said, "Although we are in clinical trials as an obesity treatment, we are also evaluating liver‑related data," adding, "This can be interpreted as suggesting the potential to evolve into a MASH treatment." The official added, "(Since we are still at phase 1,) we cannot be conclusive."
Results from a phase 1 trial of YH25724, Yuhan's MASH drug candidate, are also set to be unveiled. Yuhan had out‑licensed this candidate to C. H. Boehringer Sohn AG & Co. KG, but it was returned last year. Yuhan is continuing in‑house development. A Yuhan official said, "The presentation will be given by C. H. Boehringer Sohn AG & Co. KG, which conducted the clinical trial."
◇ Few treatments available…K‑bio moves to preempt a blue ocean
The number of MASH patients is steadily increasing in advanced countries, including Korea. According to the Korea Health Industry Development Institute (KHIDI), the global MASH patient population is estimated at 400 million. Pharmaceutical market research firm Evaluate Pharma projects the global MASH treatment market will grow from 270 billion won in 2024 to 14 trillion won in 2030.
So far, the U.S. Food and Drug Administration (FDA) has approved two MASH treatments: resmetirom by Madrigal Pharmaceuticals and Wegovy by Novo Nordisk. Because the causes of MASH are complex, developing treatments is not easy. A biotech industry official said, "If domestic corporations succeed in research and development, they can secure an early lead in the market."