Study Shows K-CAB Has a 27% Lower Risk of Hepatotoxicity

K-CAB, a new drug within the P-CAB category developed by HK inno.N for the treatment of GERD, has a 27 percent lower risk of hepatotoxicity compared with other treatments, HK inno.N said, citing a study conducted by a Korean scholar.

The study, undertaken by Professor Kim Jeong-seung of the Ear, Nose and Throat Department at Jeonbuk University Hospital, compared the hepatotoxicity of K-CAB and competitor products within the PPI category.

HK inno.N presented the study results were presented at the 2022 fall academic conference of the Korean Society of Medical Informatics, held at the Convention Center of Jeonbuk University for three days starting Nov. 23. 

The research team used big data from the Health Insurance Review and Assessment Service to compare the effects of GERD treatments in relation to liver function and damage. More studies using big data are expected to take place to boost the value of newly developed drugs.

The study showed that K-CAB had a 27% lower risk of hepatotoxicity compared to six competitor PPI drugs.

The research team extracted data on patients who were prescribed with a P-CAB drug (active ingredient: Tegoprazan) or one of the six types of PPI drugs (active ingredient: Dexlansoprazole, Esomeprzole, Lansoprazole, Pantoprazole, Rabeprazole, Omeprazole) between January 2020 and December 2020, for at least two consecutive months, from the entire database of the Health Insurance Review and Assessment Service, which contains data on 50 million patients. The data was then used to analyze the prevalence of liver diseases and various risk factors for hepatotoxicity.

To raise the validity of the study, variables that could affect the results, such as age and or history of antibiotics administration, were evenly matched, which enabled an analysis of 1,737,176 cases out of the entire 6,487,583 cases in the database.

Professor Kim commented, “The existing drugs in the P-CAB category had hepatotoxicity issues. K-CAB was found to have relatively lower risk of hepatotoxicity. This latest study used actual data from Korean patients across the country who were prescribed with K-CAB to review whether there were side effects. The study is particularly meaningful in that despite K-CAB being a new drug, quick access to data and analysis allowed us to draw significant findings”.

The research team has been studying the correlation of diseases by combining medical data with data science technologies through its medical informatics class. Established in February 2020, the medical informatics class is the first of its kind to be established at a national university in Korea.

K-CAB has been approved for a total of 5 indications, which include erosive reflux disease, non-erosive reflux disease, gastric ulcers and Helicobacter pylorieradication. It has also been approved for maintenance therapy after ERD treatment and boasts the largest number of indications among P-CAB drugs. K-CAB has been launched in two formulations, one being an immediate release tablet and the other an orally disintegrating tablet. HK inno.N is also expected to launch K-CAB 25 mg, which is half the dosage of the already launched 50 mg.