Development active for microbiome-based therapies in Korea

for incurable diseases

MD Healthcare studies new microbiome and extracellular vesicle-based therapies for CNS diseases

Enterobiome, ‘akkermansia+faecalibacterium’…R&D for new NASH-atopic dermatitis therapy

Liveome, microbiome therapy based on gene recombination technology…P1T in profess in Australia

Microbiome-based therapies have been expanding their therapeutic areas from simple digestives to immunology and oncology, receiving industry attention.

 

Based on research results that showed that imbalances in the human microbiome are highly correlated with various incurable diseases, such as cancer and obesity, and can cause immune and metabolic diseases, research is being conducted in various fields to develop treatments using microorganisms.

 

In particular, Swiss Ferring Pharmaceuticals' Rebyota (prevention of recurrence of Clostridioides difficile (C.

 

difficile) infection) received FDA approval last year, and Seres Therapeutics' Vowst (prevention of recurrence of Clostridioides difficile (C.

 

difficile) infection) was also approved this year.

 

With drugs continuing to be approved one after another, the companies are also speeding up the commercialization of their respective drugs.

 

In line with this global trend, domestic biotech companies are also entering related fields one after another and exploring their possibilities.

 

First, MD Healthcare is developing a new drug with a focus on extracellular vesicle (EV) secreted by microbiome.

 

EV is a lipid bilayer membrane secreted externally by cells that serve as vital mediators of intercellular communication.

 

The company explained that as these particles are much smaller than cells, they have high absorption capacity and thus can provide radical treatment through a mechanism that works from within the cells.

 

MD Healthcare's representative pipeline drug, 'MDH-014', targets central nervous system diseases (CNS) such as autism spectrum disorder, Alzheimer's disease, and Parkinson's disease.

 

The company had submitted an IND for the drug for the autism spectrum disorder indication and is planning to start Phase I trials next year..

 

Enterobiome is developing treatments for incurable diseases using extreme anaerobic, non-culturable, next-generation probiotic strains.

 

The company has been developing next-generation probiotics akkermansia muciniphila and faecalibacterium prausnitzii strains that show a negative correlation with various immune and metabolic diseases in the body as pharmabiotics.

 

According to domestic and international studies, akkermansia and faecalibacterium significantly reduced the gut microbiota composition of patients with immune diseases such as atopic dermatitis and cancer as well as metabolic diseases such as obesity and non-alcoholic steatohepatitis (NASH) compared to normal people.

 

Also, patients who were administered the two strains saw a treatment effect.

 

Enterobiome has currently completed non-clinical toxicity testing for its akkermansia muciniphila strain EB-AMDK19 for atopic dermatitis and is preparing to apply for an IND as a new atopic dermatitis drug early next year.

 

Akkermansia muciniphila, observed with an electron microscope.

 

Among companies that are developing next-generation microbiomes, the only two companies leading at the akkermansia R&D and commercialization stage are The Akkermansia Company in Belgium and Enterobiome in Korea.

 

Enterobiome owns a source technology for a high-concentration culture that is 1,000 times more concentrated than its competitors.

Liveome has been developing a microbiome therapy based on its gene recombination technology.

 

Libiome’s microbiome-based new drug has both the characteristics of a probiotic therapy and a gene therapy and is referred to as a ‘genetically engineered microbiota therapy.’ These treatments have the advantage of being able to increase effectiveness and drug efficacy by designing and manufacturing microorganisms according to the desired mechanism.

 

Libiome is currently conducting Phase I clinical trials in Australia for its LIV001, a candidate in its inflammatory bowel disease pipeline, that was developed using the genetic recombinant eLBP platform.

 

The candidate was selected as a new project by the Korea Drug Development Fund in July of this year and is receiving KDDF support for related R&D costs.

 

In addition, various companies such as KoBioLab, Genome & Company, and CJ Bioscience are developing treatments for incurable diseases using microbiome, therefore whether a next-generation microbiome drug following Vowst’s footsteps will be born in Korea is gaining industry attention.