Korean pharmaceuticals eye entry into global MASH market

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South Korean pharmaceutical companies are rushing to enter the global market for metabolic dysfunction-associated steatohepatitis (MASH) treatments as the world’s first cure for the metabolic disorder nears approval.

According to industry sources on Tuesday, the U.S. Food and Drug Administration (FDA) will decide whether to approve Madrigal Pharmaceuticals Inc.’s MASH treatment Resmetirom by March 14th, 2024.

Resmetirom’s priority review by the FDA began in September 2023 after its efficacy in clinical trials was confirmed. Resmetirom demonstrated an almost complete resolution of MASH a 52-week Phase 3 clinical trial, with a reduction of non-alcoholic fatty liver disease activity score (NAS) by 2 points or more in 26 percent of patients in the Resmetirom 80 milligram group and 30 percent in the 100mg group.

There is also less concern about safety, which hindered previous new drug candidates, raising even higher expectations for the first MASH treatment.

MASH, unlike disorders commonly known to be caused by alcohol consumption, is a condition where neutral fats excessively accumulate in the liver, leading to loss of function even without alcohol consumption.

Depending on the severity of symptoms, it can progress to liver fibrosis and cirrhosis, and in some cases, liver cancer and death.

The disease name was changed from non-alcoholic steatohepatitis, or NASH, to MASH at the end of 2023 during a major global liver conference, the first change in more than 40 years.

The reason MASH is attracting attention is the lack of a fundamental cure.

According to market research firm GlobalData, the global MASH treatment market is expected to hit $25.3 billion in 2026 and it is estimated that there will be over 400 million patients worldwide.

The increasing trend of patients with metabolic syndrome, accompanied by obesity and diabetes, is also a positive factor in the market outlook.

In the industry, it is expected that Resmetirom, once on the market, will generate sales of over $1 billion by 2028.

In addition to Madrigal Pharmaceuticals, several global pharmaceutical companies have entered the development of MASH treatments, but results are still modest as the unclear cause of the disease renders developing a treatment challenging.

The United States’ Gilead Sciences Inc. and France’s Genfit S.A. halted Phase 3 clinical trials in 2019 and Pfizer Inc. also discontinued Phase 1 clinical trials.

Korean companies are also accelerating their efforts.

According to the Health Insurance Review & Assessment Service, there are over 400,000 MASH patients in Korea as of 2021. The increase is steep, with the number of patients increasing by over 40 percent in five years.

Hanmi Pharm Co., entering its 10th year of MASH treatment development, has two global Phase 2 pipeline products. One of the two, HM12525A, entered Phase 2b clinical trials in July 2023 after a technology transfer to the United States’ Merck in 2020.

Yuhan Corp. exported YH25724 to Germany’s Boehringer Ingelheim Pharmaceuticals Inc. in 2019 and the duo are developing it together. YH25724 is a fusion protein incorporating biosimilar company Genexine Inc.’s antibody fusion protein platform technology, and a phase 1 clinical trial began in Europe in 2021.

Dong-A ST Co. is transferring MASH treatment DA-1241 to its U.S. subsidiary NeuroBo Pharmaceuticals Inc. and recently began the second phase of its global Phase 2 clinical trial. The efficacy and safety of DA-1241 as a single agent was evaluated in the Phase 1 clinical trial that began in September 2023.

“Developing a MASH treatment is challenging for many pharmaceutical companies but if they are successful, they are expected to quickly become big pharmaceutical companies,” an industry official said. “If the FDA approves Resmetirom, the market is expected to grow rapidly, and Korean companies are speeding up the development of their own treatments.”