Daewoong Pharmaceutical's new SGLT2 inhibitor for diabetes treatment demonstrates remarkable effect in phase 2 clinical trial

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29 Sep, 2020, 07:00 GMT

- Daewoong announced Enavogliflozin's result of phase 2 clinical trial in Korean type-2 diabetic patients at 2020 ICDM

- Aims to accelerate R&D for global market expansion through establishment of comprehensive partnerships abroad

SEOUL, South Korea, Sept. 29, 2020 /PRNewswire/ -- Daewoong Pharmaceutical (Daewoong) (CEO Sengho Jeon) announced the result of its phase 2 trial on enavogliflozin, a novel SGLT2 inhibitor, for the first time at the 2020 International Congress of Diabetes and Metabolism (ICDM) held on Sep. 18–19.

Changes in HbA1c from the baseline through 12-week administration(left). Percentage of Patients Displaying HbA1c<7.0% in Week 12(right). *Glycemic control goal in American Diabetes Association

When enavogliflozin was administered for 12 weeks as monotherapy in type-2 diabetic patients, the patients showed statistically significant decreases in their glycated hemoglobin(HbA1c) levels in comparison to the placebo starting from week 4. In week 12, the patients' HbA1c levels decreased approximately 0.9%p in comparison to the placebo. This is a statistically significant result and indicates an additional decrease in the HbA1c by approximately 0.2–0.3%p compared to other SGLT2 inhibitors for which trials were conducted in subjects in Western countries. This result, as such, raises expectations for further studies.

The percentage of patients whose HbA1c level > 7.0%* in week 12 was as high as 61%, which was an increase by more than 20%p from those in the trials conducted on existing SGLT2 inhibitors. In addition, the percentage of patients achieving the HbA1c reduction > 0.5% at week 12 was 72% at most, indicating a notable blood glucose lowering effect, when considering non-responders in other SGLT2 inhibitors.

Moreover, the proportion of patients with genital infection and urinary tract infections, adverse events that can occur according to the mechanism of SGLT2 inhibitors, was only 2%, verifying outstanding safety of the drug. This is a significantly lower rate compared to the rate of 5–10% with the SGLT2 inhibitors of other companies.

Dr. Kyongsoo Park, the coordinating investigator for this trial, said, "With the result of the phase 2 trial of enavogliflozin through monotherapy to 200 Korean subjects, the excellent blood glucose lowering effect and safety were verified." "If this remarkable efficacy and safety are confirmed through monotherapy or combination therapy in phase 3, it is expected that enavogliflozin will be used as a good treatment option for the type-2 diabetic patients," he added.

CEO Sengho Jeon at Daewoong said, "As the excellent result of the enavogliflozin, we will dedicate greater efforts to developing the best-in-class SGLT2 inhibitor." "We will accelerate R&D with a goal of global market expansion by establishing comprehensive partnerships abroad," he added.

Daewoong plans to initiate phase-3 clinical trials for multiple diabetic indications within this year. The company has established a goal to release the drug in Korea by 2023. Moreover, the indications for enavogliflozin are expected to expand obesity, heart diseases, and kidney diseases in addition to diabetes.

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