(Health Korea News / Lee Chung-man) Dong-A ST is in earnest in the development of ‘DA-5221_01’, a diabetes combination drug that combines ‘Suganon’ (ingredient name: Evogliptin) and ‘Jadien’ (ingredient name: Empagliflozin). Start the engine. This can be interpreted as an intention to further strengthen the competitiveness of the diabetes treatment market through product differentiation.
As a result of coverage by Health Korea News, it was confirmed that this company plans to recruit participants for the phase 1 clinical trial of ‘DA-5221_01’ starting on the 9th.
This test compares and evaluates the pharmacokinetic characteristics and safety of ‘DA-5221_01’ alone and the combined administration of ‘DA-5221_01-R1’ and ‘DA-5221_01-R2’ in 44 healthy adults. The clinical trial will be held at Bumin Hospital until November 16th.
‘DA-5221_01’ is a combination of Dong-A ST’s ‘Suganon’, an insulin-releasing hormone degrading enzyme (DPP-4) inhibitor, and Boehringer Ingelheim Korea’s sodium-glucose co-transporter type 2 (SGLT-2) inhibitor ‘Jadien’. It is a two-drug combination drug.
‘Suganon’ is Korea’s 26th new drug released in 2016. It is an oral hypoglycemic agent that induces insulin production by inhibiting the DPP-4 enzyme and preventing the breakdown of GLP-1, the insulin secreting hormone.
Dong-A ST is expanding its product lineup by combining diabetes treatments with various ingredients beyond ‘Suganon’. ▲’Suganon’ + metformin combination drug ‘Sugamet Tablet’ ▲’Suganon’+dapagliflozin (SGLT-2 inhibitor) combination drug ‘Sugardapa Tablet’ ▲’Suganon’+dapagliflozin+metformin 3 There is a combination drug called ‘Sugar Tree Tablet’.
‘DA-5221_01’ appears to be part of this expansion of the ‘Suganon’ portfolio. If the development of ‘DA-5221_01’ goes smoothly and is commercialized, it is expected that Korea’s first ‘Suganon’ + ‘Jadien’ diabetes combination drug will be created.
The representative competing drug for ‘DA-5221_01’ is sitagliptin (DPP-4 inhibitor) + dapagliflozin combination drug. Sitagliptin and dipagliflozin are the main ingredients of MSD’s ‘Januvia’ (ingredient name: sitagliptin) and AstraZeneca Korea Pharmaceuticals’ ‘Farxiga’ (ingredient name: dapagliflozin), respectively.
The key patents for both ‘Januvia’ and ‘Forxiga’ have expired, and numerous generic drugs are currently being distributed. As of the 7th, 108 drugs have been approved by the Ministry of Food and Drug Safety.
Another competing drug that has recently emerged is the combination of linagliptin (DPP-4 inhibitor) and empagliflozin (SGLT-2 inhibitor). The original of this drug, Boehringer Ingelheim Korea’s ‘Esglito Tablet’ (ingredient names: linagliptin, Trajenta + Empagliflozin, Jardiance), is also close to expiring its patent in 2027, and at the same time as the opening of generics, ‘DA’ Competition with ‘-5221_01’ is expected.
However, Evogliptin, the main ingredient in ‘Suganon’, is evaluated to have differentiated competitiveness as it has better safety and effectiveness than sitagliptin or linagliptin of the same series.
First, regarding safety, sitagliptin is metabolized in the kidneys. Since most drug metabolism occurs in the liver, it is interpreted that MSD designed Sitagliptin (Januvia) to be metabolized in the kidneys to reduce interactions between different drugs.
However, kidney metabolism has a lower metabolic rate than liver metabolism and requires higher doses, which may strain the patient’s kidney function. For example, the maximum dose for evogliptin (Suganon) and linagliptin (Trajenta) is 5 mg, while sitagliptin is 100 mg. Therefore, evogliptin and linagliptin appear to have higher safety compared to sitagliptin.
Here, the point where evogliptin and linagliptin stand out is their half-life (efficacy). This is because linagliptin lasts only 10 hours, while evogliptin lasts up to 35.5 hours. For reference, the half-life of sitagliptin is 12 hours.
Taken together, evogliptin is a better DPP-4 inhibitor than linagliptin and sitagliptin, and ‘DA-5221_01’, which contains evogliptin as the main ingredient, is a similar series of DPP-4 inhibitors + SGLT-2 inhibitors. It is expected to show a more improved blood sugar lowering effect than the combination drug.
Copyright © Health Korea News Unauthorized reproduction and redistribution prohibited
Source: www.hkn24.com
