Daewoong Pharmaceutical is speeding up the development of Enavogliflozin, a treatment for type-2 diabetes, after successfully licensing out a gastroesophageal reflux treatment Fexuprazan to a Chinese company.

Enavogliflozin is the nation’s first investigational sodium-glucose cotransporter-2 (SGLT-2) inhibitor. The drug helps the body excrete glucose directly into the urine by selectively inhibiting the SGLT-2 receptor, which is involved in the kidney's reabsorption of glucose.

In September, Daewoong presented the results of a phase-2 trial of Enavogliflozin in over 200 type-2 diabetic patients at the 2020 International Congress of Diabetes and Metabolism (ICDM). Enavogliflozin showed over 30 percent more reduction in lowering blood sugar (changes in glycated hemoglobin) than a conventional SGLT-2 inhibitor.

Daewoong Pharmaceutical is accelerating the development of Enavogliflozin, a treatment for type-2 diabetes. (Daewoong)
Daewoong Pharmaceutical is accelerating the development of Enavogliflozin, a treatment for type-2 diabetes. (Daewoong)

Up to 61 percent of the patients reached the international diabetes control target of below 7 percent in glycated hemoglobin. A maximum of 72 percent of patients had their glycated hemoglobin decreased by 0.5 percent compared to the level before the treatment.

Daewoong is also testing Enavogliflozin combined with metformin and a three-drug combo with metformin and dipeptidyl peptidase-4 (DPP-4) inhibitor in other trials to get three indications.

The company obtained the regulatory nod for phase-3 trials of monotherapy and combo with metformin simultaneously in September to develop the drug faster.

The monotherapy study will occur at over 30 large hospitals across the nation, including Seoul National University Hospital, in 140 patients with type-2 diabetes. The combo trial will also be conducted at over 30 hospitals in 190 type-2 diabetic patients whose blood sugar control with metformin alone is insufficient.

Daewoong presented the results of the phase-1 study of Enavogliflozin and metformin at an online meeting of the American Society for Clinical Pharmacology and Therapeutics from March 12-17. The latest nod for the phase-3 trial was based on the phase-1 results.

Using Enavogliflozin together with metformin did not affect each other because there was no significant difference in blood concentration when the two drugs were administered simultaneously, compared to the use of Enavogliflozin or metformin alone, the company said.

Professor Jang In-jin at the Seoul National University Hospital’s Clinical Pharmacology and Therapeutics, the lead investigator of the trial, said there were no drug interactions between Enavogliflozin and metformin in phase-1 study.

“Even when the patients took both drugs, there was no difference in the degree of drug absorption. So, we confirmed the safety of the combo therapy,” he said.

In October, Daewoong also obtained approval for a phase-3 trial of a three-drug combo using Enavogliflozin, metformin, and a DPP-4 inhibitor.

The company aims to roll out Enavogliflozin in 2023.

Enavogliflozin drew more attention because the Ministry of Food and Drug Safety designated the novel drug candidate as a fast-track review item. It is the first case since the MFDS set up separate counseling and fast-track review divisions in August.

The regulator completes an evaluation of a drug designated for a fast-track review within 90 days instead of the normal 120 days.

With the fast-track review designation, Daewoong can shorten the new drug review process after completing the trials of Enavogliflozin.

The global antidiabetic drug market is predicted to grow from 17 trillion won ($15 billion) in 2019 to 20 trillion won in 2024, industry officials said. Whether Daewoong can successfully commercialize the nation’s first SGLT-2 inhibitor is drawing attention, they said.

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