LG Chem's DPP-4 'Gemiglo' and
SGLT-2 'Enblo' Combination
Bioequivalence Confirmed in Bioavailability Study
Daewoong Pharmaceutical has embarked on the development of a new drug that combines the representative domestic diabetes drugs 'Envlo (active ingredient: Inavogliflozin)' and LG Chem's 'Zemiglo (Gemigliptin)' into a single pill.
Exterior view of Daewoong Pharmaceutical headquarters in Gangnam-gu, Seoul [Photo by Daewoong Pharmaceutical]
Daewoong Pharmaceutical announced on the 29th that 'DWJ1563,' a combination drug under development combining Envlo and Zemiglo, has confirmed dosing safety in Phase 1 clinical trials.
This Phase 1 clinical trial was conducted as a bioequivalence study comparing the administration of one pill of the combination drug DWJ1563 with taking Envlo and Zemiglo separately. A bioequivalence study is a test that statistically proves that the efficacy of the test drug is equivalent to that of an already marketed drug.
As a result, after randomly dividing 40 healthy adults and conducting a crossover verification, the safety and bioavailability (or absorption rate) of DWJ1563 were found to be the same as when Envlo and Zemiglo were taken separately. This confirmed that the same effect can be achieved with just one pill of the combination drug without the need to take two pills of Envlo and two pills of Zemiglo separately. ▲The concentration and duration of the drug in the blood ▲the maximum blood concentration (Cmax) indicators were all identical, meeting the pharmaceutical equivalence standards.
In particular, since the approval of Envlo tablets already recognizes the blood sugar-lowering effect through combination with metformin and metformin-gemigliptin combination therapy, Daewoong Pharmaceutical plans to accelerate the development of the combination drug based on this bioequivalence study. Professor Hwang Joon-ki of the Department of Clinical Pharmacology at Chungbuk National University Hospital, who conducted this clinical trial, stated, "This study demonstrated that the safety of the Envlo-Zemiglo combination drug is equivalent to that of co-administration, as well as the efficacy. It is expected to improve patient medication adherence and treatment outcomes."
Daewoong Pharmaceutical's diabetes treatment 'Envlo' (left) and LG Chem's diabetes treatment 'Gemiglo' [Photo by Daewoong Pharmaceutical]
The combination drug of the two medicines is expected to have synergy as Zemiglo is a dipeptidyl peptidase (DPP)-4 inhibitor that lowers blood sugar, and Envlo is a sodium-glucose co-transporter (SGLT)-2 inhibitor that promotes sugar excretion. It is also noteworthy as a combination of domestic new drugs No. 19 (Zemiglo) and No. 36 (Envlo).
Zemiglo is a leading domestic DPP-4 inhibitor class diabetes treatment drug with an annual domestic prescription amount of 100 billion KRW. DPP-4 inhibitors prolong the presence of glucagon-like peptide (GLP)-1 hormone, which promotes insulin secretion, in the body. In other words, they regulate blood sugar by increasing insulin secretion in the body. This class of diabetes drugs is the best-selling worldwide because it does not have the typical side effects of existing treatments such as ▲hypoglycemia ▲weight gain ▲digestive disorders.
Envlo is the first domestic SGLT-2 inhibitor that has reached six months since its launch. SGLT-2 inhibitors regulate blood sugar by excreting sugar through urine regardless of insulin secretion or concentration. Especially, since they act on the kidneys, they do not affect the pancreas that secretes insulin, providing the advantage of preserving the effects of each drug when combined with DPP-4 inhibitors. Envlo has previously demonstrated equivalent efficacy with only 0.3 mg, which is less than one-thirtieth of existing class treatments.
Daewoong Pharmaceutical plans to accelerate the development of the Envlo-Zemiglo combination drug to respond swiftly to the rapidly changing domestic diabetes treatment market. Considering the increasing demand for combination therapy prescriptions and the expansion of insurance coverage for SGLT-2 inhibitor combinations, Envlo-Zemiglo is expected to become a meaningful treatment option.
Especially as the diabetic population has entered the 10 million era, combination therapy accounts for about 80% of all diabetes prescriptions in Korea. Furthermore, since 2021, with the recommendation guidelines for SGLT-2 inhibitor prescriptions for diabetic kidney disease management and the expansion of insurance coverage for combination therapy this year, demand is expected to increase.
Daewoong Pharmaceutical's EnbloMet, a combination diabetes treatment of Enblo and Metformin [Photo by Daewoong Pharmaceutical]
The name of the new combination drug is likely to be 'Envlozem.' Daewoong Pharmaceutical completed the registration of Korean and English trademark patents for Envlozem in December last year. Since 'Envlomet,' also registered together, is a two-drug combination with metformin (met) and was approved last June, Envlozem is expected to be the trademark for the combination with Zem (Zemiglo).
Lee Chang-jae, CEO of Daewoong Pharmaceutical, said, "Starting with the recently launched Envlomet combination drug, we will focus on expanding the product lineup including the Envlo-Zemiglo combination drug to accelerate the establishment of the Envlo family." He added, "Since bioequivalence has been proven, we will continue to grow it into the best-in-class diabetes new drug within the class, keeping pace with the growing demand for combination drugs through Daewoong's unique four-step verification strategy."
Meanwhile, Daewoong Pharmaceutical has also been a sales partner with LG Chem, jointly marketing Zemiglo since 2016. In 2020, they agreed to extend this partnership for 10 years until 2030.
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