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US FDA Designates Fast Track for Hanmi Pharm’s “LAPS Triple Agonist”

2020.07.16



Hanmi Pharm (Se-Chang Kwon, Jong-Soo Woo, CEO and co-representative of the holding company Hanmi Science) said a few days ago that the US Food and Drug Administration (FDA) has designated LAPS Triple Agonist (HM15211), an innovative drug for the treatment of NASH (non-alcoholic steatohepatitis) manufactured by Hanmi, as a Fast Track drug.

After careful examination of new drugs with good curative effects for very serious diseases or diseases threatening human life, FDA will designate the drugs as "fast track" drugs when it considers it necessary to develop them as soon as possible.

After being designated as FDA fast-track drugs, FDA will fully support them at all stages of development. Through close consultation with FDA, new drugs can be developed faster than usual.

LAPS Triple Agonist is a triple (Glucagon/GIP/GLP-1) agonist that can overcome the limitations of a single target oral treatment and is the first-in-class new drug to which Hanmi Pharm's proprietary platform “LAPS Scopery” is applied.

Glutenin, one of the components of LAPS Triple Agonist, can directly reduce fatty liver and inhibit fibrosis. At the same time, GLP-1, which has the effect of insulin secretion and appetite suppression, can activate GIP, which has the effect of insulin secretion and anti-inflammatory, and target fatty liver, inflammation, and fibrosis simultaneously.

LAPSTriple Agonist can simultaneously improve all indicators and measure the efficacy of NASH. It can be found that this drug may be the most innovative drug among NASH therapeutic drugs currently being developed globally.



Authorization authorities such as the United States and Europe have set the requirements for permits as NASH has the nature of causing "complex disease without treatment". Recently, most global pharmaceutical companies have failed in the clinical development stage because they cannot prove that NASH has obvious curative effect on the causes of multiple diseases.

Therefore, if LAPS Triple Agonist, based on triple agents, is finally commercially available, it is expected to lead the NASH therapeutic agent market of billions of won.

In fact, multiple studies on the LAPS Triple Agonist drug in patients with obese NAFLD (non-alcoholic fatty liver disease) have demonstrated its innovation.

Hanmi Pharm confirmed a significant fat reduction effect in NAFLD patients with obesity through MRI-PDFF (Magnetic Resonance Imaging-Proton Density Fat Fraction).

The majority of LAPS Triple Agonist patients showed a curative effect of reducing fatty liver by more than 50% within three months, and its rapid effectiveness was also confirmed in terms of fat synthesis and oxidation (targeting liver).

On the 16th of last month, ADA (American Diabetes Association), the world's largest diabetes association, announced the research results of LAPS Triple Agonist.

In this report, Hanmi Pharm revealed that it was confirmed that the NASH model has direct treatment and improvement efficacy in fatty liver, liver inflammation, and fibrosis. In addition, LAPS Triple Agonist was administered into the model of primary biliary and sclerosing cholangitis induced by surgical therapy, and the results confirmed its strong anti-inflammatory and anti-fibrosis effects. Since March this year, LAPS Triple Agonist has been continuously designated by FDA as a rare drug for the treatment of primary biliary cholangitis and primary sclerosing cholangitis.

Currently, Hanmi Pharm has demonstrated rapid reduction of fatty liver in Phase 1 clinical trials in most patients treated with LAPS Triple Agonist. To confirm NASH and fibrosis improvement of LAPS Triple Agonist, clinical double-blind trials are being conducted with FDA approval for biopsy patients.

"We are convinced that LAPS Triple Agonist is the most advanced first-in-class innovative drug among NASH therapeutics currently being developed around the world. After being designated as the fast track drug by FDA, LAPS Triple Agonist will soon see accelerate pace of the development and commercialization. We will do our best and make this drug a game changer in this field." said Se-Chang Kwon, President and CEO of Hanmi Pharm.

Source: Medipana News