Highly anticipated to be an effective therapeutic for its excellent efficacies in reducing blood glucose levels and safety
SEOUL, South Korea, Nov. 2, 2022 /PRNewswire/ — Daewoong Pharmaceutical (Daewoong), the South Korea-based global healthcare company, announced the phase III clinical trial results of the new diabetes drug ‘Enavogliflozin.’
Daewoong (CEO Sengho Jeon & Changjae Lee) announced on October 31th that they had revealed the results of three phase III clinical trials for Enavogliflozin monotherapy, Enavogliflozin-Metformin combination therapy, and Enavogliflozin-Metformin-Gemigliptin combination therapy at the 2022 International Congress of Diabetes and Metabolism (2022 ICDM).
All three Enavogliflozin phase 3 clinical trials confirmed the efficacy and safety for 24 weeks of dosing. The target patients for each study were as follows. For the Enavogliflozin monotherapy trial, 160 T2DM patients with inadequately controlled with diet and exercise were enrolled. For dual combination therapy trial, 200 T2DM patients with inadequate response to metformin were enrolled. For triple combination therapy trial, 270 T2DM patients with inadequate response to Metformin plus Gemigliptin were enrolled.
The Enavogliflozin monotherapy trial was a placebo-controlled superiority study. The HbA1c decreased in the Enavogliflozin group by approximately 1% over the placebo group, which was statistically significant. In addition, significant improvements were confirmed in weight, blood pressure, low-density lipoprotein cholesterol (LDL-C), and high-density lipoprotein cholesterol (HDL-C) compared to the placebo group. The two combination trials, Enavogliflozin-Metformin and Enavogliflozin-Metformin-Gemigliptin combination, demonstrated non-inferiority in HbAc1 change compared to dapagliflozin 10 mg.
Soo-Heon Kwak, Professor of Endocrinology and Metabolism at Seoul National University Hospital, presented the clinical results as the lead author of the Enavogliflozin monotherapy trial at the 2022 ICDM, said, “In this monotherapy trial, we could demonstrate Enavogliflozin’s superior hypoglycemic activity and safety compared to placebo. It is expected to be an effective treatment option for T2DM patients for its hypoglycemic effect and improving metabolic abnormalities such as weight, blood pressure, cholesterol, etc.”.
Enavogliflozin is a new diabetes drug in the SGLT-2 (sodium-glucose cotransporter-2) inhibitor class, which Daewoong has been developing for the first time in South Korea. The hypoglycemic mechanism of SGLT-2 is selective inhibition of the SGLT-2 transporter involved in glucose reabsorption in the kidney’s proximal tubule to excrete glucose directly into the urine.
Phase III clinical trials of Enavogliflozin, designated as South Korea’s first drug subject to fast-track review in 2020, was approved in September 2020 for both monotherapy and metformin combination therapy, and October, metformin/Gemigliptin combination therapy. After the fast-track review, the NDA (New drug application) of Enavogliflozin was submitted in March 2022, which was 18 months from the IND submission for phase III clinical trials. Daewoong aims to get approved by MFDS this year and launch Enavogliflozin in the Korean market by the first half of 2023.
“We expect to improve the quality of life of T2DM patients around the world by promptly launching the next-generation diabetes drug, Enavogliflozin.” said Sengho Jeon, CEO of Daewoong Pharmaceutical.