Hanmi’s anti-NASH drug candidate set to become ‘game changer’ in global pharmaceutical market

Feb 28, 2020

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                              (LAPSTriple Agonist)
Hanmi’s anti-NASH drug candidate set to become ‘game changer’ in global pharmaceutical market

First-in-class GLP-1/GIP/Glucagon triple agonist drug candidate
Proven efficacy in treating fatty liver, liver inflammation, liver fibrosis
Phase 2 global clinical study will be initiated in the first half of the year

Hanmi Pharmaceutical is flexing its muscles to make its innovative anti-NASH drug candidate LAPSTriple Agonist (HM15211) a “game changer,” reshaping the landscape of the global pharmaceutical industry.

A Hanmi official said that the study results and development progress of company’s LAPSTriple Agonist had attracted keen attention from many key opinion leaders (KOL) of major global pharmaceutical companies at the 38th J.P. Morgan Healthcare Conference, held in January in San Francisco, the United States. 

Hanmi stated that such a positive reaction shall be credited to LAPSTriple Agonist’s proven and impressive efficacy in treating multiple conditions.

LAPSTriple Agonist is Hanmi’s first-in-class Glucagon/GIP/GLP-1 triple agonist based on the company’s innovative LAPSCOVERY technology, effectively treating NASH patients.

Glucagon, a component of LAPSTriple Agonist, plays a direct role of reducing the fat in the liver and prevents liver fibrosis. At the same time, it activates GLP-1 to release insulin and control appetite, and GIP to release insulin and make anti-inflammatory effect, resulting in treating fatty livers, liver inflammation and liver fibrosis simultaneously.

Its efficacy was proven in the Phase 1 trials in patients with obesity and non-alcoholic fatty liver disease (NAFLD).

The Magnetic Resonance Imaging Proton Density Fat Fraction (MRI-PDFF) test results indicated the patients’ liver fat volume reduced to “a meaningful level.”

Most NASH patients showed their liver fat reduced by more than 30 percent within three months after they were treated with LAPSTriple Agonist. LAPSTriple Agonist also showed rapid and potent liver-targeted action for de novo lipogenesis and beta-oxidation.

From the animal study with deliberately induced liver inflammation and fibrosis, LAPSTriple Agonist showed impressive performance in relieving inflammation and fibrosis, compared with placebo-controlled groups and farnesoid X receptor (FXR)-injected groups.

Hanmi is planning to begin the global Phase 2 trials of LAPSTriple Agonist in the second quarter this year with biopsy-proven NASH patients.

The uniqueness of LAPSTriple Agonist in its potency of simultaneous improvement of multiple indicators gives the drug candidate a position of advantage over other competitors in a crowded landscape to develop an anti-NASH drug.

The regulatory authorities in United States and Europe set a high bar for commercialization of an anti-NASH treatment because of the fact that treatment is considered to be effective only when it improves multiple indicators simultaneously. This could be challenging as it is one of the key reasons major drug makers are still struggling in the clinical stages with their drug candidates falling short of required performances.

In fact, among hundreds of clinical trials of anti-NASH drugs posted on international clinical trials information website, Clinicaltrials.gov, Hanmi’s LAPSTriple Agonist is the only durg candidate proven effective in improving multiple indicators simultaneously. Therefore, if Hanmi’s LAPSTriple Agonist gets approved and commercialized, it will be able to lead the world’s multi-trillion won NASH treatment market.

“I believe LAPSTriple Agonist is the most advanced anti-NASH treatment among first-in-class drug candidates for NASH under development around the world,” said Hanmi CEO Se Chang Kwon. “We will make all-out efforts for its commercialization to realize our goal of leading the world’s anti-NASH drug market that is still devoid of a commercialized drug with proven efficacy.”