Daewoong Pharmaceutical obtains approval for phase-3 clinical trials in South Korea for third indications of new drug Enavogliflozin for diabetes treatment

Daewoong Pharmaceutical obtains approval for phase-3 clinical trials in South Korea for third indications of new drug Enavogliflozin for diabetes treatment - South Korea’s first SGLT2 inhibitor new drug Enavogliflozin for diabetes treatment… Obtains phase-3 clinical trial approval for metformin, DPP-4 inhibitor and triple combination therapy. - Expected to lead the expansion of the SLGT2 inhibitor market with third indications after monotherapy and metformin combination therapy - Designated for expedited review for the first time in South Korea… Planned to be released in Korean markets in 2023 Daewoong Pharmeceutical is strengthening its competitiveness with the expansion of indications of Enavogliflozin. Daewoong Pharmaceutical (Daewoong) (CEO Sengho Jeon) announced that Daewoong obtained approval for phase-3 clinical trials for combination therapy using the new drugs for diabetes treatment Enavocliflozin as well as metformin and DPP-4 inhibitors on the 30th. Enavocliflozin is the first SLGT2 diabetes treatment in development by a South Korean company. During this phase-3 clinical trial, the safety and blood glucose reduction effects compared to conventional treatments have been proven through combination therapy using metformin, DPP-4 inhibitors, and Enavocliflozin in 250 type-2 diabetes patients who cannot sufficiently control blood glucose with combination therapy using metformin and DPP-4 inhibitors. The clinical trials will take place in 20 university hospitals across the country, including the Catholic Univ. of Korea Bucheon St. Mary’s Hospital. As Daewoong obtained phase-3 clinical trial approval for triple combination therapy following Enavocliflozin monotherapy and metformin combination therapy, Enavocliflozin is planned to be used by patients whose blood glucose cannot be controlled using existing diabetes treatments and combination therapy. The global diabetes treatment market in key countries is expected to grow from KRW 17 trillion in 2019 to about KRW 20 trillion in 2024, and triple combination therapy is responsible of 25% of the domestic market share for diabetes treatments. Daewoong plans to further increase their market share by adding indications for Enavocliflozin. Especially, Daewoong’s Enavocliflozin was designated for expedited review (fast track) for the first time in Korea, which can reduce the amount of time until drug approval, and is expected to be released in Korean markets in 2023. CEO Sengho Jeon at Daewoong said, “Daewoong is giving its utmost efforts in expanding its Enavocliflozin indications so it can help blood glucose regulation for type 2 diabetes patients with minor to major symptoms.” He added, “As SLGT2 inhibitors are expanding into areas of heart failure and chronic heart failure, we are planning to expand the areas of treatment for Enavocliflozin aside from treating diabetes.” On the other hand, Enavocliflozin is a SLGT2 inhibitor that uses the mechanic of directly discharging glucose through urine by selectively inhibiting SLGT2 transporters that are related to the reabsorption of glucose in the kidneys. Successful phase-2 clinical results were disclosed to the public for the first time at the 2020 International Congress of Diabetes and Metabolism (ICDM) in September. According to the results of the phase-2 clinical trial, upon comparison against the placebo after 12 weeks of injection on type 2 diabetes patients, the variance of glycated hemoglobin (HbA1c) has been observed to have decreased an additional 0.9% compared to the placebo. This is an observation of a reduction of more than 30% compared to conventional SLGT2 inhibitors which were geared towards westerners. Additionally, the percentage of subjects with 7.0% or less glycated hemoglobin, which is an international diabetes regulation target, were 61% at its maximum, and the percentage of subjects who experienced a decrease of over 0.5% in glycated hemoglobin levels compared to pre-treatment was 72%, which were more effective compared to conventional SLGT2 inhibitors. # # #

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