(Health Korea News / Lee Chung-man) HK inno.N is entering into full-scale clinical trials for its new drug candidate for the treatment of chronic idiopathic constipation (CIC), ‘IN-114199’.
HK inno.N received approval for the Phase 1 clinical trial plan (IND) for ‘IN-114199’ from the Ministry of Food and Drug Safety on the 29th. The test is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and dietary effects of ‘IN-114199’ after oral administration to healthy adults. It will be conducted at Seoul National University Hospital.
The target disease of ‘IN-114199’ is CIC. CIC is a chronic constipation condition of unknown cause, a disease that shows continuous constipation symptoms without any specific underlying disease or drug cause. The main cause is decreased intestinal motility, and it is most common in women and the elderly.
Improving the diet, including dietary fiber and water, and regular exercise can help treat CIC. However, these methods do not work consistently for all patients. Some CIC patients require drug treatment.
The problem is that the cause of CIC is not known exactly, so treatment options are very limited. Although laxatives such as bulk-forming laxatives, osmotic laxatives, stimulant laxatives, and 5-HT4 receptor agonists are administered, it is known that about 50% of patients are not satisfied.
HK inno.N’s ‘IN-114199’ is a new CIC treatment drug that aims to address these unmet medical needs. The drug selectively acts on the ileal bile acid transporter (IBAT) to improve CIC.
IBAT is expressed in the ileum of the small intestine. This factor plays a role in regulating the concentration of bile acids by acting on the process in which bile acids produced in the liver enter the small intestine to aid digestion and are then absorbed by the liver.
At this time, IBAT inhibitors including ‘IN-114199’ inhibit the activity of IBAT and reduce the reabsorption rate of bile acids. When the level of bile acids in the small intestine increases, water absorption in the intestine increases, making the stool loose, and this can improve CIC.
High concentrations of bile acids in the small intestine are known to be a factor causing diarrhea. Therefore, the treatment of diarrhea is usually focused on reducing bile acid levels, but IBAT inhibitors are an approach that uses this in reverse to increase bile acid levels.
There are currently three approved IBAT inhibitors, and among them, the one that has secured indications for CIC treatment is ‘Goofice’ (ingredient name: elobixibat) from Eisai of Japan. Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) approved ‘Goofice’ as a CIC treatment in January 2018.
However, ‘Gupis’ has not been approved in any country except Japan. Sweden’s Albireo, the original owner of Eloxibat, the ingredient in ‘Gupis’, is conducting clinical trials for entry into the US market, but the indication is for the treatment of metabolic steatohepatitis (MASH).
Therefore, if the development of ‘IN-114199’ proceeds smoothly and is commercialized, it is expected that the first IBAT inhibitor new drug for CIC treatment in Korea will be born.
Copyright © Health Korea News. Unauthorized reproduction and redistribution prohibited.
Source: www.hkn24.com
