Daewoong Pharmaceutical said it would begin a phase 1 trial of Enavogliflozin (DWP161001), a sodium-glucose cotransporter-2 (SGLT-2) inhibitor for type-2 diabetes, targeting multiple ethnic groups.

On Wednesday, the company received approval from the Ministry of Food and Drug Safety (MFDS) to conduct the local phase 1 study.

Daewoong Pharmaceutical said it would start a phase 1 trial of Enavogliflozin to tap the global diabetes treatment market.
Daewoong Pharmaceutical said it would start a phase 1 trial of Enavogliflozin to tap the global diabetes treatment market.

Daewoong will administer DWP161001 orally to Koreans, Westerners, and Latin Americans to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of the antidiabetic drug at the Seoul National University Hospital.

The company is expected to use the multiracial phase 1 trial data to enter the global diabetes treatment market.

Daewoong expects the global SGLT-2 inhibitor market to grow from 17 trillion won in 2019 to 20 trillion won in 2024.

An official at Daewoong said the company aimed to “confirm the drug's safety in various ethnic groups including Latin Americans and Hispanic people.”

Enavogliflozin is an SGLT-2 inhibitor, a diabetes treatment being developed by Daewoong.

The investigational drug excretes glucose directly into urine by selectively inhibiting the SGLT2 receptor involved in the kidney’s glucose reabsorption.

Daewoong is testing the drug as a monotherapy, a combo with metformin, and a three-drug combo with metformin and dipeptidyl peptidase-4 (DPP-4) inhibitor.

The company began an extended trial in August after completing a phase 3 study of the monotherapy in January.

Daewoong also finished recruiting patients for the two-drug and three-drug combination therapies.

Daewoong said it would also seek to expand the indication of Enavogliflozin as a weight control treatment.

In August, Daewoong obtained the regulatory nod to conduct a phase 1 trial of DWP306001 to reduce blood sugar and weight.

DWP306001 is a combo drug mixing Enavogliflozin with an appetite suppressant DWC202010.

If Daewoong develops Enavogliflozin successfully, the drug will become the nation’s first locally developed SGLT-2 inhibitor.

In October last year, the MFDS designated Enavogliflozin as a fast-track review item.

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

Daewoong aims to release Enavogliflozin in Korea in 2023.

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