(Health Korea News / Lee Chung-man) While combination drugs combining two or more drugs have become the mainstream treatment for chronic diseases, there is still a market for them. This is the angiotensin II receptor blocker (ARB) + sodium glucose cotransporter type 2 (SGLT-2) inhibitor market. Since the combination of this ingredient has not yet been approved by the Ministry of Food and Drug Safety, the company that develops it first is expected to enjoy first mover status.
Looking at the mechanism of action of each ingredient, ARB drugs relax blood vessels and lower blood pressure by blocking the angiotensin hormone, which acts on blood vessel constriction. The ingredient name ends in -sartan and is also called a sartan preparation.
SGLT-2 inhibitors are a mechanism that blocks the reabsorption of glucose excreted in urine into the bloodstream by selectively inhibiting SGLT-2, which is involved in the reabsorption of glucose in the kidney (renal tubules).
Therefore, the combination of ARB + SGLT-2 inhibitor is expected to be able to effectively manage diabetes and hypertension simultaneously.
Considering that the majority of diabetic patients have high blood pressure, the prospects for ARB+SGLT-2 inhibitors are very encouraging. According to the Korean Diabetes Association’s ‘Diabetes Fact Sheet in Korea 2020’, 61.3% of people with diabetes in Korea’s adult population over 30 years old also suffer from high blood pressure.
Nevertheless, the ARB agent + SGLT-2 inhibitor has not yet obtained approval from the Ministry of Food and Drug Safety. Considering that five-drug combination drugs are currently being released in addition to four-drug combination drugs, this raises curiosity.
This is interpreted to be because the daily usage regimens of each drug that could be used as a combination drug ingredient were different. While high blood pressure medications are standardized to be taken once a day, diabetes medications can be taken once a day or twice a day, depending on need. This led to difficulties in developing combination drugs.
Meanwhile, as the patent barrier for AstraZeneca’s diabetes treatment ‘Farxiga’ (ingredient name: dapagliflozin), whose dosage is fixed to once a day, has been lifted, companies are starting to develop ARB+SGLT-2 inhibitors in earnest. am.
There are a total of 4 ARB+SGLT-2 inhibitors currently under development, and looking at their ingredients, it can be seen that the role of ‘Forxiga’ is crucial.
▲Boryung’s ‘BR1019’ (fimasartan + dapagliflozin) ▲Youngjin Pharmaceutical’s ‘ATB-101’ (olmesartan + dapagliflozin) ▲Hallim Pharmaceutical’s ‘HL1113’ (candesartan + dapagliflozin) Pagliflozin) ▲ CMG Pharmaceutical’s ‘CMG1904’ (telmisartan + dapagliflozin) are all SGLT-2 inhibitors that use dapagliflozin, a component of ‘Farxiga’.
However, as the ingredients of ARB preparations used in combination drugs are different, the comparative advantage and competitiveness of the drugs is expected to vary depending on the results of demonstrating superior efficacy and safety after launch.
The drug expected to be released first is Boryung’s ‘BR1019’. Boryung received Phase 3 IND approval for ‘BR1019’ from the Ministry of Food and Drug Safety in November 2023, and began recruiting Phase 3 patients in May of this year. At the same time, the company is focusing on strengthening the competitiveness of ‘BR1019’ by conducting additional phase 1 trials of ‘BR1019’ one after another this year.
According to the phase 3 clinical design of ‘BR1019’, the expected trial period is until January 2026. Therefore, ‘BR1019’ is expected to obtain approval from the Ministry of Food and Drug Safety around 2027.
The second mover is likely to be Youngjin Pharmaceutical’s ‘ATB-101’. Youngjin Pharmaceutical began recruiting phase 3 patients for ‘ATB-101’ on August 19 of this year and entered the final stages of obtaining approval.
Hallym Pharmaceutical’s ‘HL1113’ and CMG Pharmaceutical’s ‘CMG1904’ are still in the phase 1 stage, so it is expected to take a long time to get approval from the Ministry of Food and Drug Safety. Among these, CMG Pharmaceuticals is recruiting participants for the phase 1 clinical trial of ‘CMG1904’ starting today (22nd).
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Source: www.hkn24.com
