바이오스펙테이터

바이오스펙테이터 Joungmin Cho 기자

Kobiolabs, the domestic new drug developer based on microbiome, is moving with speed into global clinical trials of the two kinds of candidate materials of new drugs aimed at atopy and severe asthma. After the foundation by Professor Ko Gwang-pyo of Seoul National University in 2014, this will be the first clinical trial for the pipeline of the new drug.

Simultaneously, Kobiolabs is starting to implement a two-track strategy for making inroads into the markets of ‘Curebiotics’, the therapeutic agents for diseases, and ‘Carebiotics’, the functional foods for healthcare.

President Ko Gwang-pyo stated, “… we have launched the brand of healthcare and functional foods, of the ‘Carebiotics’, the ‘Biobiome’, successfully last year. The global Phase-1 Clinical Trials for the two therapeutic agents are scheduled in this year; thereby, we will be able to access the development of new microbiome drugs further ahead…”

◇ Phase-1 Clinical Trials for the New Drugs for Atopy and Asthma … “Pipelines are Expanding Every Year for Metabolic Disease and Anticancer Agents”

Kobiolabs is currently developing new drugs by excavating bacterial strains that are effective for obesity, diabetes mellitus, infectious disease including C.difficile, inflammatory bowel disease, and atopy, based on the Bio-Bank containing more than 5,000 species of strains secured through analyses of specimens originated from human, and the database of microbiomes of more than 3,000 people in Korea.

Among them, the most advanced pipelines for new drugs are those of atopy and severe asthma, which are scheduled for global clinical trials this year. Before entering into the global clinical trials, Kobiolabs established a local corporation in Australia for the management of clinical trials. President Ko stated, “… for the new drugs of microbiome, the markets of Europe and the United States of America were targeted, and thereby, the Clinical Trials of Phase-1 were determined to be in progress globally.” Kobiolabs is going to produce new drugs through CMO enterprises equipped with production facilities of GMP level, and selected local contract research organizations (CROs) in charge of the clinical trials.

Kobiolabs plans to expand pipelines entering into clinical trials every year, from the base of the initiation of two clinical trials. President Ko said, “… recently, we are excavating and verifying candidate materials for new drugs by performing basic research on bacterial strains and protein that exhibit therapeutic effects to liver diseases, such as NASH and NAFLD, as well as anticancer pipelines that are spotlighted with great interest. We expect tangible results therefrom to be available in the second half of 2020, or in the first half of 2021.”

◇ The Healthcare and Functional Foods, Associated with Bowel Health, Immunity, and Stress Control, are Released to Market, and the Functionalities Thereof have been Proved through Clinics.

Kobiolabs launched the ‘Biobiome’, the spontaneous brand for functional foods last year, and released three products associated with bowel health, immunity, and stress control, respectively, to the market. They intend product development by verifying the safety and functionality through conducting human application test, animal test, and the separation and identification of microorganisms associated with diseases.

The company recently announced that the domestic clinical trials for the three species of strains of KBLF001, KBLF002, and KBLF003, the candidates for probiotics products that help the relaxation of strain due to stress and atopy, are in progress.

President Ko stated, “… the clinical trials currently in progress are estimated to conclude at the end of this year, while the final results therefrom are expected to be available in the first half of 2020. Based on the results, the application for the approval of raw materials for individually certified functional foods will be presented, together with promotion for commercialization.”

He also emphasized, “… the discipline of microbiome is a highly competitive field in the global market. Kobiolabs will focus on growth as an R&D company, which is based on sustainable research and development for consecutive outcomes that contribute to the advancement of pipelines.”