Daewoong Pharmaceutical Announces Successful Phase 3 Topline Results for New Antidiabetic Drug's Triple Combination Therapy

- Successfully completed combination therapy of the new antidiabetic drug Enavogliflozin with Metformin and Gemigliptin

- Confirmed positive phase 3 topline results in addition to Enavogliflozin monotherapy and Metformin combination therapy

- Expected to officially announce study outcomes through academic journals upon completion of final analysis

SEOUL, South Korea, Feb. 25, 2022 /PRNewswire/ -- Daewoong Pharmaceutical (Daewoong) announced the topline results of the phase 3 clinical trial for a triple combination therapy of Enavogliflozin, a new antidiabetic drug with the mechanism of SGLT-2 inhibitor, with Metformin and Gemigliptin. Enavogliflozin is an SGLT-2 inhibitor for diabetes in development by Daewoong for the first time in South Korea.

Professor Sungrae Kim of the Catholic University of Korea Bucheon St. Mary's Hospital as a coordinating investigator and principal investigators from 27 institutions have participated in the phase 3 clinical trial for Enavogliflozin as a triple combination therapy with Metformin and Gemigliptin. The study was conducted as a multi-center, randomized, double-blind, and active-controlled confirmatory phase 3 clinical trial which comprised of 270 patients with type 2 diabetes.

Patients with type 2 diabetes, who had been administered Metformin and Gemigliptin, were additionally administered Enavogliflozin or Dapagliflozin for 24 weeks, and the baseline change of glycated hemoglobin (HbA1c) between the two study groups was compared during the treatment period. As a result, the patients administered Enavogliflozin showed a decrease in HbA1c level by 0.92% and by 0.86% in those administered Dapagliflozin, thereby proving the non-inferiority of Enavogliflozin compared to Dapagliflozin.

The safety of Enavogliflozin was also verified in the patients with moderate diabetes, who required combination therapy of Metformin and Gemigliptin, as there were no unexpected adverse drug reactions nor drug-drug interactions. The safety of Enavogliflozin has been proven through three sequential clinical trials of monotherapy, metformin combination, and Metformin and Gemigliptin combination.

The coordinating investigator Professor Kim said, "The clinical trial of Enavogliflozin's triple combination therapy in comparison with Dapagliflozin on about 270 Korean T2DM patients for 24 weeks has proven the safety and outstanding blood glucose lowering effects of Enavogliflozin." "It is expected Enavogliflozin becomes the better treatment option with the indication for monotherapy and combination therapy," he added.

Bringing out meaningful results from the phase 3 clinical trial of Enavogliflozin's triple combination therapy, Daewoong is now a step closer to the release of a new SGLT-2 inhibitor for the first time in South Korea. Daewoong plans to immediately apply for the new drug approval and to launch not only Enavogliflozin but also Enavogliflozin/Metformin fixed-dose-combination drug by the first half of 2023. Daewoong released the topline results of the phase 3 clinical trial of Enavogliflozin monotherapy and Metformin combination therapy this January.

"With the success of this clinical trial, we are putting all our efforts to market the best-in-class antidiabetic drug for patients with mild to moderate diabetes," commented Changjae Lee, Daewoong Pharmaceutical CEO. "Daewoong will help diabetes patients through the release of Enavogliflozin, designated as the fast-track drug for the first time in South Korea, while continuing to secure new drug portfolio as a global healthcare company."