Domestic pharmaceutical companies are rushing to develop a treatment for non-alcoholic steatohepatitis (NASH).
NASH is an inflammation of the liver caused by a buildup of triglycerides in the liver, even when the person rarely drinks alcohol. If it gets worse, it may cause severe fibrosis or cirrhosis. Obese and diabetic patients are highly likely to develop NASH, but there is no treatment.
Not only multinational pharmaceuticals but local ones are speeding up to develop a treatment for NASH. The search for the treatment drew more attention after Yuhab Corp. inked an $870 million licensing-out deal with Boehringer Ingelheim recently.
Korean companies working on a NASH drug include Yuhan, Dong-A ST, ST Pharm, Hanmi Pharmaceutical, Enzychem Lifesciences, Samil Pharmaceutical, Huons, PharmaKING, CJ Healthcare (Kolmar Korea), and LG Chem.
Yuhan licensed out NASH drug candidate YH25724 to Boehringer Ingelheim for $870 million in July.
YH25724 is a dual agonist for GLP-1 and FGF21, currently in a pre-clinical trial. It targets the body hormone GLP-1, which increases insulin secretion, and FGF21, which regulates glucose produced in the liver, lipid metabolism and energy homeostasis.
Hanmi’s investigational drug HM15211 aims to be a once-a-week injection. It is a biologic drug candidate that simultaneously activates glucagon that improves lipid metabolism by increasing energy metabolism, GLP-1 that controls insulin and appetite, and GIP receptor that secrets insulin and has an anti-inflammatory effect.
Hanmi announced the drug’s use in three non-clinical cases and the result of phase 1 on the drug at the meeting of the American Diabetes Association in the U.S. in June.
Dong-A ST is reportedly seeking to add NASH to DA-1241’s desired indication for diabetes.
ST Pharm, an affiliate of Dong-A Socio Holdings, signed an agreement with Korea Research Institute of Chemical Technology to jointly develop a new drug that regulates the activity of protein Sirtuin6. The protein is related to the regulation of metabolism, inflammation, and aging/immune response.
PharmaKING obtained local approval to conduct a phase-3 trial on PMK-N01GI1 (ingredient: oltipraz) on Tuesday last week. The study evaluates the efficacy and safety of the drug in the reduction of liver fat in 144 patients with NASH who do not have cirrhosis.
Samil Pharmaceutical secured a local development and sales right of Aramchol from Israel’s Galmed Pharmaceuticals in 2016.
Huons is developing a NASH treatment derived from natural ingredients.
Huons' experimental drug HL Tab. uses extracts of a silver magnolia tree. The company is reportedly planning a phase 3 study.