Daewoong's DWP16001, approved for Phase III clinical trial

The MFDS simultaneously approved two clinical trials on September 29th

Expected as the first domestic SGLT-2 drug

The SGLT-2 diabetes treatment drug being developed by Daewoong is entering phase III of clinical trial.

 

This drug is expected to become the first domestic SGLT-2 diabetes drug if it obtains product approval.

 

On the 29th of last month, the MFDS approved phase III clinical trial plan for Daewoong's new drug candidate 'DWP16001'.

 

DWP16001 is a SGLT-2 inhibitor drug such as Forxiga (AZ), Jardiance (Boehringer Ingelheim), and Suglat (Astellas) that are commercially available in Korea.

 

Daewoong is developing and introducing substances from GC Pharma in May 2016.

 

Inhibition of SGLT-2 Diabetes treatment has a mechanism of selectively inhibiting SGLT-2, a transporter that reabsorbs glucose from the kidneys, preventing glucose from being reabsorbed, and controlling blood sugar by excreting it in the urine.

 

It is also famous as a 'fat-losing diabetes medicine' because it has weight control effects.

 

SGLT-2 inhibitor drugs and DPP-4 inhibitory drugs are rivals in the domestic diabetes treatment market.

 

According to UBIST, Forxiga's outpatient prescriptions amounted to ₩17.6 billion in the first half of this year, up 10.1% year-on-year.

 

Sales of Jardiance was ₩16.8 billion, up 66.7% year-on-year, and Suglet’s sales amount was ₩1.6 billion, up 16.7% year-on-year.

 

Daewoong has been jointly selling Forxiga in cooperation with AstraZeneca since 2018.

 

It can be said that distribution network has already been established before the development of new drugs.

 

In addition, Daewoong is selling DPP-4 diabetes treatment Zemiglo (LG Chem), showing its strong influence in the diabetes drug market.

 

This phase IIII clinical trial of DWP16001 is conducted to evaluate the safety and efficacy of a combination therapy with Metformin in patients with type 2 diabetes who have insufficient glycemic control with Metformin and monotherapy in type 2 diabetes patients.

 

Phase III clinical trial of monotherapy is conducted at Seoul National University Hospital for 140 domestic patients.

 

The phase III clinical trial of Metformin combination therapy will be conducted in 190 patients at Seoul St.

 

Mary's Hospital.

 

It is interpreted as a strategy to simultaneously acquire major indications by conducting two-tracks.

 

Daewoong revealed the results of phase I clinical trial of DWP16001 through a poster presentation at the '2019 European Association for the Study of Diabetes (EASD)' held in Barcelona, Spain in September last year.

 

According to the results, in phase I, DWP16001 showed excellent urinary glucose secretion (glucose excreted in the urine) at a dose of 1/100 compared to drugs of the same category.

 

In addition, when repeated administration for 15 days, the daily urinary glucose secretion of the active control group was 40g, while the daily urinary glucose secretion of the DWP16001 group was 50g or more.

 

Daewoong received approval for phase II clinical trial from the MFDS in May last year, and approved phase III clinical trial within 1 year and 5 months, and is proceeding with commercialization plans smoothly.

 

Daewoong plans to release this drug in Korea in 2023.