While Daewoong Pharmaceutical has successfully exported Peksuprazan technology for gastroesophageal reflux disease, another new drug candidate, Inabogliflozin, is also spurring the development of type 2 diabetes treatment.
Inabogliflozin is the first SGLT-2 inhibitor-based diabetes treatment that Daewoong Pharmaceutical is developing among Korean pharmaceutical companies. It is a drug that causes glucose to be excreted directly into the urine by selectively inhibiting the SGLT2 receptor, which is involved in the reabsorption of glucose in the kidney.
According to Daewoong Pharmaceutical’s presentation at the International Conference on Diabetes and Metabolic Diseases (ICDM) in September of last year, Inabogliflo was conducted in a domestic phase 2 clinical trial on 200 patients with type 2 diabetes whose blood sugar was not properly controlled. Jin showed a blood glucose lowering effect (change in glycated hemoglobin) of 30% or more compared to the existing SGLT-2 drug. The international diabetes control target’the proportion of patients who reached below 7.0% of glycated hemoglobin’ reached a maximum of 61%, and the proportion of patients whose glycated hemoglobin decreased by more than 0.5% compared to before treatment reached a maximum of 72%.
Currently, Daewoong Pharmaceutical is actively conducting clinical trials with a total of three indications targets, including metroformin combination therapy, metformin and three DPP-4 inhibitor therapy, in addition to Inabogliflozin alone therapy.
To this end, Daewoong Pharmaceutical received approval from the Ministry of Food and Drug Safety in September of last year to simultaneously evaluate the efficacy and safety of monotherapy and metformin combination therapy. The plan is to further accelerate development by proceeding with each of the three phases at the same time.
In the case of monotherapy, 140 patients with type 2 diabetes are conducted at 30 large hospitals nationwide including Seoul National University Hospital, and in the case of metformin combination therapy, type 2 diabetes patients with insufficient blood sugar control with metformin 190 Targeting the Dawning Target, it will be held at about 30 large hospitals nationwide, including the Catholic University of Seoul St. Mary’s Hospital.
Daewoong Pharmaceutical recently announced the results of the first phase of the combination of Inabogliflozin and metformin, which was the basis for this phase 3 approval. It was held online from the 12th to the 17th (local time) at the American Society of Clinical Pharmacology.
Daewoong Pharmaceutical explained that the clinical results of comparing the blood concentrations of drugs showed that the two drugs did not affect each other because there was no significant difference in blood concentration when the two drugs were administered together compared to the administration of Inabogliflozin or metformin alone.
Professor Jang In-jin of the Department of Clinical Pharmacology, Seoul National University Hospital, who is in charge of the study, said, “Drug interaction was not reported when Inabogliflozin and metformin were used in combination through Phase 1. Safety was confirmed when administered.”
Daewoong Pharmaceutical also received approval for Phase 3 of the three-drug combination therapy of Inabogliflozin, metformin, and DPP-4 inhibitor in October last year.
In 250 patients with type 2 diabetes who do not sufficiently control blood sugar even if metformin and DPP-4 inhibitor are administered in combination, the hypoglycemic effect compared to conventional drugs when Inabogliflozin is administered together with metformin and DPP-4 inhibitor. We plan to check the safety. Clinical trials are conducted in about 20 large hospitals nationwide, including the Catholic University of Bucheon St. Mary’s Hospital.
Through a series of clinical trials, Daewoong Pharmaceutical aims to release Inabogliflozin in Korea in 2023.
What is raising expectations is that Inabogliflozin has been designated as a drug subject to rapid review (Fasttrack) by the Ministry of Food and Drug Safety as it is a new drug developed in Korea. This is the first case designated after the Ministry of Food and Drug Safety established the’Prior Consultation Division’ and the’Expedited Review Division’ in August of last year. The Ministry of Food and Drug Safety established a rapid review system and reorganized the organization in charge in order to shorten the productization period of pharmaceuticals.
Drugs designated for expedited review are reviewed within 90 days, which is 30 days shorter than the legal processing period of 120 days at the time of approval review. You can also benefit from prior consultation and prior consultation by the Ministry of Food and Drug Safety.
With Daewoong Pharmaceutical’s designation as a subject for rapid evaluation of Inabogliflozin, Daewoong Pharmaceutical can shorten the time period for obtaining approval for a new drug after completing the clinical trial of Inabogliflozin.
In this regard, Park Hyun-jin, head of the development division of Daewoong Pharmaceutical, said, “Based on the clinical results that when taking Navogliflozin and metformin together, the two drugs do not affect each other, we are developing three indications from single therapy to combination therapy at the same time. “We will accelerate the development of Inabogliflozin as the best new drug in the family so that it can help control blood sugar in many type 2 diabetic patients who do not control blood sugar with existing treatments.”
While the size of the global diabetes treatment market in major countries is expected to grow from 17 trillion won in 2019 to about 20 trillion won in 2024, attention is paid to whether Daewoong Pharmaceutical will be able to successfully commercialize SGLT-2 inhibitor-based diabetes treatments for the first time in Korea.