PH3s of Daewoong’s SGLT-2i antidiabetic near completion

Completes Phase III trial on Enavogliflozin+metformin combo… monotherapy trial also near completion

Completes patient enrollment for Phase III trial on 3-drug combo with gemigliptin…plans to apply for approval next year

#1i Clinical trials for the new antidiabetic SGLT-2 inhibitor ‘Enavogliflozin’ in development by Daewoong Pharmaceutical are gaining speed.

 

One of the three Phase III clinical trials is already complete, and the remaining two are also nearing their final stages after completing patient recruitment.

 

With such progress, the industry expects the authorities to grant marketing authorization for Enavogliflozin within the first half of next year, then be released in 2023.

 

◆Phase III trial on two-drug combo complete… trials on monotherapy and three-drug combo also in final stages According to the industry on the 10th, Daewoong Pharmaceutical had recently completed the Phase III trial for its Enavogliflozin(DWP16001)+metformin combination therapy.

 

Enavogliflozin, a new SGLT-2 inhibitor antidiabetic, is the first SGLTi developed by a domestic pharmaceutical company.

 

Other antidiabetic SGLTi options available include AstraZeneca’s ‘Forxiga,’ Boehringer Ingelheim’s ‘Jardiance,’ Astellas’ ‘Suglat,’ MSD’s ‘Steglatro,’ among others.

 

Last year, Daewoong Pharmaceutical had received approval to initiate a Phase III clinical trial on 190 patients with type 2 diabetes in 24 hospitals in Korea, including Seoul Saint Mary’s hospital, to assess the efficacy of its Enavogliflozin+metformin combination therapy.

 

After registering the last patient in May this year, the company completed observations on the last patient in November and is currently analyzing clinical data.

 

The company had initially expected to complete the trial by December 2023, but due to smooth progress, the end date was pulled forward by a year.

 

Other clinical trials on Enavogliflozin are also in smooth progress.

 

Daewoong Pharmaceutical is currently running 3 trials related to Enavogliflozin.

 

In addition to its two-drug combination trial on Enavogliflozin+metformin, the company is also assessing Enavogliflozin as a monotherapy and a three-drug combination that uses metformin and DDP-4 inhibitor in addition to Enavogliflozin.

 

Among these, the Phase III trial on the Enavogliflozin monotherapy has started in September last year on 140 patients in Korea.

 

Patient recruitment is now complete and observation of the last patient is expected to be completed within this year at the earliest.

 

The patient recruitment for the three-drug combo has also been completed.

 

Daewoong Pharmaceuticals had received approval to initiate a Phase III trial to assess the efficacy of the Enavogliflozin+metformin+DPP-4 inhibitor combination on 256 patients last October.

 

LG Chem’s gemigliptin was selected as the DPP-4 inhibitor for the three-drug combo, and patient recruitment was completed in August this year.

 

With all three Phase III trials coming to an end, prospects on when the drug will be authorized have also been rising.

 

The pharmaceutical industry believes that it is strongly likely that the company will apply for marketing authorization next year and release the drug in 2023.

 

Daewoong Pharmaceutical had originally planned to release its drug in 2023.

 

The pharmaceutical industry believes that there is a strong possibility that the company will apply for product approval in the first half of next year and release it in 2023.

 

Daewoong Pharmaceutical had originally planned to release it in 2023.

 

◆ Extension studies for data acquisition also in smooth progress… started trials to enter global market For the Enavogliflozin monotherapy and the two-drug combination using metformin, an extension (long-term administration) trial is also underway in addition to the Phase III trial.

 

Trials on long-term administration of drugs are usually conducted after the product is released, but Daewoong Pharmaceutical plans to release the drug after securing relevant data.

 

The company’s move to first secure the long-term clinical data is interpreted as a strategic attempt to compete with existing SGLT-2 inhibitors.

 

The extension trial for the Enavogliflozin monotherapy was approved in August this year.

 

The clinical trial size is 70.

 

The company started the trial in full by starting recruitment in September last year.

 

The extension trial for the two-drug combination therapy using metformin was approved in March this year, and the company had succeeded in recruiting all 100 patients in November.

 

The trial is expected to be completed by the first half of next year.

 

With existing Enavogliflozin trials entering completion, the company has also been initiating new trials.

 

The company had started a Phase I trial targeting Koreans, Westerners, and Latin American patients on December 1st.

 

It is explained that the trial was prepared with global expansion in mind.

 

The company is also actively seeking indication extensions.

 

In August this year, the company had received approval to initiate a Phase I trial for DWP30600.

 

DWP30600 is a combination of Enavogliflozin and an anorectic agent (DWC202010).