Hanmi Pharmaceutical (co-CEOs Kwon Se-Chang and Woo Jong-Soo; holding company Hanmi Science) announced on July 16th that its LAPSTriple Agonist (HM15211), an innovative new drug for nonalcoholic steatohepatitis (NASH), had received Fast Track designation from the U.S. Food and Drug Administration (FDA).
The FDA grants Fast Track designation for a highly efficacious new drug for a serious or life-threatening disease if its careful review suggests a need for expedited development.
A drug that receives the FDA's Fast Track designation is provided with extensive support from the FDA at each stage of development and can be developed faster than other general cases through close consultation with the FDA.
LAPSTriple Agonist (Glucagon/GIP/GLP-1) is a first-in-class new drug that can overcome the limitations of single-target oral treatments and utilizes Hanmi Pharmaceutical's proprietary platform technology, LAPSCOVERY.
Glucagon, one of the components of LAPSTriple Agonist, directly acts to reduce fatty liver and inhibits fibrosis. It also simultaneously activates GLP-1, which facilitates insulin secretion and helps suppress appetite, and GIP, which facilitates insulin secretion and anti-inflammatory effect, targeting fatty liver, inflammation, and fibrosis all at the same time.
The fact that LAPSTriple Agonist can simultaneously improve various indicators that are used as criteria to evaluate the effectiveness of NASH treatment is evidence for its potential to be more innovative than any other competing drug currently in development worldwide for treatment of NASH.
Permit authorities in the United States and Europe have set stringent licensing requirements for a NASH treatment because NASH has the nature of 'a complex disease without treatment.' Recent failures of many global pharmaceutical companies in the clinical development stage are also due to their inability to demonstrate distinct therapeutic effects for NASH, which has been caused by complex conditions.
Therefore, if LAPSTriple Agonist is finally commercialized, it is expected to lead the NASH treatment market, which is estimated to reach tens of trillions of won.
In fact, LAPSTriple Agonist has demonstrated its innovative effects in various studies on non-alcoholic fatty liver disease (NAFLD) patients with obesity.
Hanmi Pharmaceutical confirmed significant fat-reducing effect in NAFLD patients with obesity using magnetic resonance imaging-derived proton density fat fraction (MRI-PDFF).
Liver fat decreased by 50% or more within 3 months in most of the patients treated with LAPSTriple Agonist, and the drug demonstrated a fast and strong effect on (liver-targeted) fatty acid biosynthesis and beta oxidation.
On June 16th, Hanmi Pharmaceutical presented its research results on LAPSTriple Agonist at the American Diabetes Association (ADA), the world's largest academic society on diabetes.
In this presentation, Hanmi Pharmaceutical reported its observation of efficacy of the drug in directly treating and improving fatty liver, liver inflammation, and fibrosis in a NASH model. When administered in the models of surgery-induced primary biliary and sclerosing cholangitis, LAPSTriple Agonist also demonstrated strong anti-inflammatory and anti-fibrotic effects. In March, the U.S. FDA designated LAPSTriple Agonist as an orphan drug for the treatment of primary biliary cholangitis and primary sclerosing cholangitis.
After demonstrating rapid liver fat-reducing effect in most patients treated with LAPSTriple Agonist in the Phase I clinical trial, Hanmi Pharmaceutical is conducting a Phase II clinical trial after obtaining the U.S. FDA approval to demonstrate that LAPSTriple Agonist improves NASH and fibrosis in biopsy-confirmed patients.
Kwon Se-Chang, CEO of Hanmi Pharmaceutical, said, 'We are confident that LAPSTriple Agonist is the world's most innovative and leading first-in-class drug currently in development for NASH treatment. The U.S. FDA's fast track designation of LAPSTriple Agonist will speed up its development and commercialization. We will make our best efforts to be a game changer in this field.'
Contact:
Tel: +82-2-410-9114
Fax: +82-2-410-9259
HANMI PHARM. CO., LTD. 
