Hanmi Pharmaceutical’s NASH- proved its potential as an innovative drug for obesity


On September 25th, Hanmi Pharmaceutical announced that it presented the research results at the 56th European Association for the Study of Diabetes(ESAD) held online from September 21st to 25th. Three studies are on LAPSTriple Agonist(HM15211), an innovative new drug for Non-Alcoholic Steato Hepatitis(NASH), and two studies are on LAPSGlucagon Analog (HM15136), an innovative new drug for diabetes.

Firstly, LAPSTriple Agonist is a triple-acting biologic drug candidate that simultaneously activates glucagon, which increases energy metabolism in the body, GLP-1, which helps secrete insulin and suppress appetite, and GIP receptors which secrete insulin and have anti-inflammatory action.

While various NASH drug candidates currently being developed around the world are only targeting specific parts of the disease, LAPSTriple Agonist, a triple agent, simultaneously targets fatty liver, hepatic inflammation and liver fibrosis, all of which are key indicators of NASH treatment.

At this year’s EASD, Hanmi Pharmaceutical unveiled three studies demonstrating the efficacy of LAPSTriple Agonist in various models that induce NASH, liver fibrosis, and biliary identity cholangitis.

In this study, especially, various fibrosis markers and histological liver fibrosis improvement effects were confirmed compared to FXR agonist (ingredient name: obeticholic acid) and GLP-1/GIP dual agonist, competing drugs. In addition, it was discovered the mechanism that the efficacy of LAPSTriple Agonist in improving fatty hepatitis and fibrosis is both a side effect from weight loss and a direct effect on the disease.

At the American Diabetes Association (ADA) held in June, Hanmi Pharm proved the rapid fat liver reduction effect of LAPSTriple Agonist in phase 1 clinical trial. It decreased more than 50% of fat liver in most of the patients within three months. With FDA’s clinical trial approval, Hanmi Pharm is conducting a phase 2 clinical trial to confirm that LAPSTriple Agonist improves NASH and fibrosis for patients whose disease was confirmed by biopsy.

In March, the FDA designated LAPSTriple Agonist as an orphan drug for primary biliary cholangitis and primary sclerosing cholangitis. On July 16, FDA also designated it as a Fast Track (new drug) to expedite its development.

The research on LAPSGlucagon Analog presented at this EASD used an animal model to prove a new mechanism of obesity treatment different from the widely adopted obesity drugs based on GLP-1.

The weight loss mechanism of current obesity drugs either being used or under development have limited efficacy on suppressing appetite. On the other hand, the obesity induction model confirmed that LAPSGlucagon Analog induces weight loss through a complex mechanism of suppressing lipid absorption while burning energy as well as suppressing appetite.

Long-term administration of LAPSGlucagon Analog to obese animal models confirmed the efficacy including continuous reduction of liver and blood lipids and improvement of insulin sensitivity. It also shows the possibility to improve obesity and risk factors of related metabolic diseases.

Hanmi Pharmaceutical is currently conducting the phase 1 clinical trials for obese patients in the United States. It tests the safety, tolerability, and weight loss efficacy through repeated administration of LAPSGlucagon Analog.

Sechang Kwon, the CEO of Hanmi Pharmaceutical, said: "Various biologic drugs based on Labscovery are continuously expanding the scope of development, and moving ahead in the globally competitive therapeutic areas at a very fast speed.”, "We will continue to develop innovative new drugs showing a new paradigm for metabolic disease treatment."

Source: EBN