Daewoong Pharmaceutical Pharmaceutical announced the results of a phase III clinical trial of a new diabetes drug "Enavog-liflozin"

On November 2, 2022, Daewoong Pharmaceutical ("Daewoong"), a global healthcare company headquartered in South Korea, announced the results
of a Phase III clinical trial of Enavog-liflozin, a new diabetes drug.

Daewoong (CEO Sengho Jeon and Changjae Lee) announced on October 31 that at the 2022 International Congress on Diabetes and Metabolism ("ICDM 2022") held at the Svisgrande Hotel in Seoul from October 7 to 8, the company disclosed its treatment for Enavog-liflozin monotherapy, Enavog-liflozin-metformin dual therapy, and the results of
three phase III clinical trials of Enavog-liflozin-metformin-gemigliptin triple therapy.

All three Enavog-liflozin Phase III clinical trials confirmed the efficacy and safety
of the 24-week dose.
The target patients for each study are as follows
.
The Enavog-liflozin monotherapy trial enrolled 160 patients
with T2DM who had poor control over diet and exercise.
The dual and triple therapy trials enrolled 200 patients with T2DM who did not respond significantly to metformin and 270 patients with T2DM who did not respond well to metformin-gemigliptin combination
.

The Enavog-liflozin monotherapy trial was a placebo-controlled, better-than-favor trial
.
The Enavog-liflozin group had a decrease in HbA1c levels of about 1% compared to the placebo group, which is statistically significant
.
In addition, significant improvements
in weight, blood pressure, low-density lipoprotein cholesterol (LDL-C) and high-density lipoprotein cholesterol (HDL-C) were demonstrated in the Enavog-liflozin group compared to the placebo group.

The Enavog-liflozin-metformin dual therapy trial demonstrated a non-inferiority in HbAc1 changes compared with 10 mg of dapagliflozin, and a significant improvement
in insulin resistance (HOMA-IR).
In addition, the safety and tolerability
of the drug reaction is also verified by the small adverse drug reactions.
In addition, changes in HbAc1 in Enavog-liflozin-metformin-gemigliptin triple therapy were also shown to be non-inferior
, compared to dapagliflozin.

Soo-Heon Kwak, Professor of Endocrinology and Metabolism at Seoul National University Hospital and the lead author of the Enavog-liflozin monotherapy trial, presented the clinical results at the 2022 ICDM, saying, "In this monotherapy trial, we can demonstrate superior hypoglycemic activity and safety
profile of Enavog-liflozin compared to placebo.
It not only has a hypoglycemic effect, but also improves metabolic abnormalities such as weight, blood pressure, and cholesterol, and is expected to become an effective treatment for
T2DM patients.
"

Enavog-liflozin is Daewoong's first SGLT-2 (sodium-glucose cotransporter 2) inhibitor-based diabetes drug
developed in Korea.
The hypoglycemic mechanism of SGLT-2 is to selectively inhibit the SGLT-2 transporter involved in glucose reabsorption in the proximal renal tubule, directly excreting glucose into the
urine.

Enavog-liflozin is scheduled to be the first drug in Korea to undergo rapid review in 2020, with Phase III clinical trials of monotherapy and metformin combination approved in September 2020 and Phase III trials of metformin/gemigliptin combination therapy approved in October
.
After a quick review, Enavog-liflozin's NDA (New Drug Application) was filed in March 2022, 18 months
after the IND submission for the Phase III clinical trial.
Daewoong aims to obtain approval from the Korean Ministry of Food and Drug Safety (MFDS) this year and launch Enavog-liflozin
in the Korean market in the first half of 2023.

Daewoong is also preparing to supply Enavog-liflozin
worldwide.
The company has a plan to roll out the drug in ten major countries including China, Brazil and Saudi Arabia by 2025 and to about 50 countries
by 2030.
According to IQVIA, a global market research firm, the global SGLT-2 inhibitors market size was approximately $20.
6 billion in 2021, an increase of 34% compared to the previous year, and these inhibitors have shown extremely high marketability
.

Sengho Jeon, CEO of Daewoong Pharmaceutical, said: "Daewoong is developing Enavog-liflozin, which has outstanding hypoglycemic effect and is one of
the best drugs in its class.
We hope to improve the quality of life of
T2DM patients in Korea and around the world by rapidly launching Enavog-liflozin, a next-generation diabetes drug.
" "