K-Bio speeds up novel drug development to treat MASH

"Commercialization expected"

Developing dual-targeted·triple-targeted agents using GLP-1·glucagon·GIP

Biotech companies, D&D pharmatech and OliX Pharmaceuticals, enter clinical trials for MASH

The biotech industry in South Korea has made notable achievements in treating MASH.

 

Many pharmaceutical companies have failed in clinical trials to develop a treatment for MASH due to its complex pathogenesis.

 

As the first treatment for MASH has been approved, the industry draws attention to the success of the commercialization of other new drug candidates of various pharmaceutical companies that entered clinical trials in South Korea.

 

On July 11th, the current trend in the MASH treatment development was discussed during the Bioplus-Interphex Korea 2024 (BIX 2024), sponsored by the Korea Biotechnology Industry Organization (Korea Bio) and RX Korea.

 

MASH was previously known as Non-Alcoholic Steatohepatitis (NASH).

 

International academic associations, such as the American Association for the Study of Liver Diseases (AASLD), agreed upon the use of the term Metabolic dysfunction-associated steatohepatitis (MASH).

 

Developing treatment for MASH has been challenging until now.

 

However, the first novel drug to treat MASH in March became available after the U.S.-based Madrigal Pharmaceuticals’ Rezdiffra was approved.

 

The late-comers eye on the opportunity to develop the second potential novel drug development through various mechanisms.

 

Lee Seul-ki, D&D pharmatech CEO

D&D pharmatech has entered a phase 2 trial in the United States.

 

The company has recently received approval for its Investigational New Drug (IND) application from the U.S.

 

Food and Drug Administration (FDA).

 

DD01’s phase 2 trial will be conducted across 10 institutions in the United States, enrolling 68 patients with MASH-accompanying overweight and obesity.

 

DD01 is an agent targeting both GLP-1 and glucagon.

 

In preclinical trials, D&D pharmatech’s DD01, an agent targeting both GLP-1 and glucagon, has shown a significant decrease in liver fat and a weigh loss effect.

 

DD01’s effect has been maintained in a phase 1 trial.

 

The phase 1 trial evaluated the drug tolerance and safety of DD01 and placebo in patients with MASH accompanied by obesity instead of in healthy adults.

 

The clinical results demonstrated that a 4-week DD01 treatment reduced liver fat by 52%.

 

These results were similar to those of the 1-year treatment with semaglutide (57% reduction) or Tirzepatide (47% reduction).

 

High-dose (80 mg) DD01 treatment reduced liver fat by 30% in all patients.

 

In contrast, the placebo’s reduction effect was shown in 8% of all patients.

 

Lee Seul-ki, D&D pharmatech’s CEO, said, “We believe that glucagon plays an important role because many obesity patients also have MASH.

 

Clinical studies reported that glucagon therapy reduces liver fibrosis by 50-80%.” Lee added that “DD01 is formulated with GLP-1 and glucagon in a ratio of 10:1.

 

In a preclinical study, DD01 demonstrated to maintain the effect of GLP-1 as well as the effect of glucagon.” “We need a drug that effectively regulates blood glucose and weight to treat MASH.

 

GLP-1 drugs that can quickly elevate blood glucose have adverse reactions, such as dizziness and vomiting.

 

For DD01, we confirmed that it is more slowly released into the blood than other therapies.

 

Additionally, we received approval of an IND application for a new protein therapy targeting collagen synthesis and investigating the potential of various novel drugs,” Lee commented.

 

OliX Pharmaceuticals is developing a new drug candidate, OLX75016, to treat MASH.

 

OLX75016 works by inhibiting MARC1 expression, which is related to the pathogenesis of MASH and reducing liver fat.

 

June Hyun Park, OliX Pharmaceuticals Director

OliX Pharmaceuticals has recently entered a phase 1 trial for OLX75016 in Australia and started the first patient administration.

 

Notably, OliX Pharmaceuticals is investigating the possibility of using OLX75016 in combination with novel drugs targeting GLP-1 and glucagon.

 

Since most MASH treatments target GLP-1, OliX Pharmaceuticals plans to develop treatments that have distinguished mechanisms and improve synergistic effects with GLP-1 agents.

 

In a preclinical trial, OLX702A demonstrated effects in reducing liver fat and reversing liver fibrosis.

 

June Hyun Park, OliX Pharmaceuticals Director, said, “Fibrosis contributes to deaths associated with liver.

 

We are confirming the role of MARC1 in liver fibrosis.

 

As we confirm MARC1 as an important factor in fibrosis, we are exploring the potential of novel drug development.”