Daewoong Pharmaceutical’s enavogliflozin monotherapy and metformin combination therapy obtains phase-3 clinical trial approval simultaneously

“Korea’s first SGLT2 inhibitor for diabetes treatment” Daewoong Pharmaceutical’s enavogliflozin monotherapy and metformin combination therapy obtains phase-3 clinical trial approval simultaneously - Aims to obtain key indicants that make up more than 50% of the SGLT2 treatment market simultaneously - Development is to be accelerated based on its successful phase-2 clinical trial results… Aims to release in Korean markets by 2023 Daewoong Pharmaceutical (Daewoong) (CEO Sengho Jeon) simultaneously obtained phase-3 clinical trial approval for the independent use of enavogliflozin, a new SGLT2 inhibitor, and the combined usage of metformin, and plans to further accelerate development on these products. Daewoong simultaneously obtained phase-3 clinical trial approval for each of their new SLGT2 inhibitor for diabetes treatment—enavogliflozin monotherapy and metformin combination therapy—from the Ministry of Food and Drug Safety, which evaluates the efficacy and safety of each of the treatments. The clinical trial for independent use will be carried out targeting about 140 type 2 diabetes patients in about 30 university hospitals across the country, including Seoul National University Hospital. Furthermore, the clinical trials for the Metformin combination therapy targeting about 190 type 2 diabetes patients who are unable to sufficiently regulate blood glucose using only Metformin is planned to be carried out in about 30 university hospitals across the country including the Catholic Univ. of Korea Seoul St. Mary’s Hospital. Enavogliflozin is a SLGT2 inhibitor which uses the mechanism of flushing glucose directly through urination by selectively suppressing SLGT-2 receptors that are related to the reabsorption of glucose in the kidneys. It has been introduced for the first time at the 2020 International Congress of Diabetes and Metabolism (ICDM) in September, based on successful phase-2 clinical trial results. According to the results of the phase-2 clinical trial, the variance of glycated hemoglobin (HbA1c), which is a key measure of blood glucose regulation, was about 0.9% after 12 weeks compared to the placebo, which is an observation of a reduction of more than 30% compared to conventional SLGT2 inhibitors which were geared towards Westerners, and more effective results can be expected from the upcoming phase-3 clinical trial. Additionally, the international diabetes regulation target for percentage of subjects who have achieved under 7.0% of glycated hemoglobin were 61% at maximum, which displayed more than 20% satisfactory results compared to conventional SLGT2 inhibitors. The percentage of subjects who experienced a decrease of over 0.5% in glycated hemoglobin levels compared to pre-treatment was 72%, which were greater than 40-60% observed in drugs of the same class; further demonstrating the effective blood glucose reduction of the treatment. [Fig.] Percentage of subjects who experienced a decrease of over 0.5% HbA1c in week 12 compared to the baseline CEO Sengho Jeon at Daewoong said, “Daewoong is planning to focus its R&D capabilities on its new SLGT2 diabetes drug of enavogliflozin so it can secure its place among its competitors as the best in class,” and “We will strive to target the global market as well as the domestic market, and provide enavogliflozin as a great option for type 2 diabetes patients.” On the other hand, as SLGT2 inhibitors are expanding into the area of treating cardiac insufficiency and chronic renal failure, enavogliflozin is also anticipated to expand its efficacy in treating not only diabetes, but also obesity, heart disease, and kidney failure. The global diabetes treatment market is expected to grow from KRW 17 trillion to about KRW 20 trillion by 2024. Daewoong is aiming to release enavogliflozin in the domestic market by 2023. # # #

The release as fetched from its publisher. daewoong.co.kr ↗