Daewoong Pharmaceutical Announce Publication of Phase 3 Study of ‘Envlo’, a New Treatment for Diabetes

The research results of a Daewoong Pharmaceutical SGLT-2 inhibitor new drug for diabetes, ‘Envlo’, have been internationally acknowledged. On April 4, Daewoong Pharmaceutical announced that the efficacy and safety evaluation study of monotherapy of the 36th novel drug from South Korea, Envlo (ingredient name: Enavogliflozin) (ENHANCE-A), has been published in the international SCIE journal, ‘Diabetes, Obesity and Metabolism, DOM.’

The title of the paper is ‘Efficacy and safety of enavogliflozin, a novel SGLT2 inhibitor, in Korean people with type 2 diabetes: A 24-week, multicentre, randomized, double-blind, placebo-controlled, phase III trial.’

According to the study, the efficacy endpoint ‘change of glycated hemoglobin (HbA1c) level at Week 24 after administration of Envlo’ showed -0.88%p for Envlo group and 0.11%p for placebo group, and a significant difference between the two groups showed -0.99%p, proving the superiority of Envlo compared to placebo. Also, no significant differences were found in the incidence of adverse events, adverse drug reaction, and serious adverse events between the two groups.

It was statistically significant (p<0.0001) that the proportion of subjects achieving a therapeutic glycemic response (HbA1c < 7% or < 6.5%), indicating the potential as an effective diabetes treatment. Moreover, there was evidence of indirect improvement effects, such as insulin resistance (HOMA-IR) and obesity-related indicators. Meanwhile, Daewoong Pharmaceutical also released a paper on the phase 3 study of the combination therapy of Envlo with metformin (ENHANCE-M) and metformin & gemigliptin (ENHANCE-D).

The ENHANCE-M study was published in the Diabetes & Metabolism Journal (DMJ) and has demonstrated non-inferiority in the change rate of HbA1c compared to Dapagliflozin. It confirmed significant improvement of HOMA-IR, and showed excellent effects on improving albuminuria in the sub-analysis of diabetes patients with albuminuria. The ENHANCE-D study has been published in the international SCIE paper, ‘Diabetes & Metabolism (DM)’, and proved non-inferiority in the change rate of HbA1c compared to Dapagliflozin.

“This research provides approval for a domestic new drug and meaningful clinical evidence to diabetes patients,” said Chang-jae Lee, representative of Daewoong Pharmaceutical. “Through this publication, we have verified excellent blood glucose lowering effects and metabolic improvements in Korean diabetes patients, and we are planning and conducting various studies to secure additional indications and clinical evidence for diabetes and other comorbidities such as heart disease, kidney disease, and obesity.”