Korean pharmaceutical and biotech corporations will unveil research results on liver disease treatments 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, overseas, one of the two leading societies along with the American Association for the Study of Liver Diseases. It could be a venue to gauge the latest research trends, make an impression on global drugmakers, and discuss technology transfer.
This year's meeting is expected to feature active discussions on metabolic dysfunction–associated steatohepatitis (MASH), commonly known as "fatty liver." It occurs when excess fat accumulates in the liver and triggers inflammation, which can lead to hepatitis, cirrhosis, and liver cancer. It can occur even without drinking alcohol. Corporations are taking on the challenge of not only reducing fat but also improving fibrosis, which hardens the liver.
◇ Fat reduction and fibrosis improvement… taking on the conquest of MASH
D&D Pharmatech will disclose key phase 2 endpoints for the MASH treatment candidate DD01. It plans to reveal liver biopsy results on how much fibrosis improved at week 48 of patient dosing. Previously, 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 (GLP)-1 and the glucagon receptor. GLP-1 is a hormone that promotes insulin secretion from the pancreas. While mainly used as an obesity treatment, its efficacy against MASH has recently been demonstrated, spurring active new drug development using it.
D&D Pharmatech will advance development of the MASH therapy through phase 2. From phase 3, it will pursue out-licensing (technology transfer). Because doing phase 3 directly would require massive expense and time, the plan is to pursue technology transfer.
◇ Makeover of obesity drugs? Potential for liver treatment as well
Metabio, an affiliate of Dong-A ST, will present research findings on the obesity drug candidate DA-1726. Likewise, it acts simultaneously on the 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 phase 1. By day 54 of treatment, body weight decreased and liver stiffness fell 10.3% from baseline. Reduced stiffness is regarded as an indicator that can be linked to improvement in liver fibrosis.
A company representative said, "Although the clinical trial is for an obesity drug, we are also evaluating liver-related data," adding, "It can be interpreted as suggesting the potential to evolve into a MASH therapy." The person added, "(Since it is still in phase 1,) we cannot be conclusive."
Results from phase 1 of Yuhan's MASH treatment candidate YH25724 are also set to be disclosed. 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 representative said, "The presentation will be given by C. H. Boehringer Sohn AG & Co. KG, which conducted the clinical trial."
◇ Few available treatments… K-bio moves to preempt a blue ocean
The number of MASH patients is steadily increasing in advanced economies, including Korea. According to the Korea Health Industry Development Institute (KHIDI), the global MASH patient population is estimated at 400 million. Evaluate Pharma, a pharmaceutical market research firm, projects that 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: Madrigal Pharmaceuticals' resmetirom and Novo Nordisk's Wegovy. MASH has complex causes, making drug development difficult. A biotech industry representative said, "If domestic corporations succeed in research and development, they can secure an early lead in the market."