Daewoong Pharmaceutical announced the results of the phase 3 clinical trial for its diabetes drug ‘inavogliflozin’.
Daewoong Pharmaceutical was held at the International Congress of Diabetes and Metabolism (ICDM) held at the Grand Hotel in Seoul, Switzerland, on the 7th and 8th for two days, inavogliflozin ▲Single therapy ▲Metformin 2 combination therapy ▲Metformin/Zemi The company announced on the 12th that it has published the results of a phase 3 clinical trial on a combination therapy of 3 gliptin.
This phase 3 clinical study conducted for domestic product approval of inavogliflozin confirmed the efficacy and safety of inavogliflozin through 24 weeks of administration in all three cases.
Each study was conducted in 160 patients with type 2 diabetes whose blood sugar was not controlled by diet and exercise in the case of monotherapy, 200 patients with type 2 diabetes who could not control their blood sugar with metformin in combination therapy with metformin, and 3 The combination was conducted in 270 patients with type 2 diabetes whose glycemic control was not achieved with metformin and zemigliptin.
The monotherapy trial was conducted as a placebo-controlled superiority trial, and the glycated hemoglobin (HbA1c) decreased by about 1%p compared to placebo, securing statistical significance.
In addition, significant improvements were confirmed compared to placebo in body weight, blood pressure, low density lipoprotein cholesterol (LDL-C), and high density lipoprotein cholesterol (HDL-C).
In the metformin combination study, it demonstrated non-inferiority in the rate of change of glycated hemoglobin compared to the active control drug, dapagliflozin, and at the same time confirmed a significant improvement in insulin resistance (HOMA-IR). In addition, safety and tolerability were verified by confirming significantly low adverse drug reactions in terms of safety.
In addition, the metformin and gemigliptin combination test also proved that it was non-inferior in the rate of change of glycated hemoglobin compared to the active control drug dapagliflozin.
Suheon Kwak, Professor of Endocrinology and Metabolism at Seoul National University Hospital, who presented the clinical results as the lead author of the monotherapy trial at this international conference of the Korean Diabetes Association, said, “Inavogliflozin is a monotherapy for type 2 diabetes patients. In the study, superior blood sugar lowering effect and safety compared to placebo were confirmed, and it is expected to be an effective treatment option that combines the effect of improving metabolic abnormalities such as weight, blood pressure, and cholesterol in addition to the blood sugar lowering effect in type 2 diabetes patients who require monotherapy or combination therapy. ” said
Inavogliflozin is a new diabetes drug in the SGLT-2 (sodium glucose cotransporter-2) inhibitor class, which Daewoong Pharm is developing for the first time in Korea.
SGLT-2 inhibitors exist in the proximal tubule of the kidney (kidney) and selectively inhibit the SGLT-2 transporter, which is involved in glucose reabsorption, and have a mechanism to reduce blood sugar by excreting glucose directly into the urine.
Inavogliflozin, which was designated as Korea’s first drug subject to rapid review in 2020, applied for product approval to the Ministry of Food and Drug Safety at the end of March for all three indications. Daewoong Pharm is aiming for product approval within this year and domestic launch in the first half of 2023.
Inavogliflozin, which was designated as Korea’s first drug subject to rapid review in 2020, received approval for a phase 3 clinical trial (IND) in September 2020 for single and metformin combination therapy and in October for metformin/zemigliptin combination therapy. After that, through expedited review, it applied for product approval at the end of March 2022, about 18 months later, and is aiming for product approval within this year and domestic release in the first half of 2023.
Lee Chang-jae, CEO of Daewoong Pharmaceutical, said, “We are developing Inabogliflozin, which has an excellent blood sugar-strengthening effect, as the best-in-class drug. “We look forward to improving the quality of life for patients suffering from diabetes all over the world, including,” he said.
Meanwhile, according to global market research company IQVIA, as of 2021, the global market for SGLT-2 inhibitors is worth about 27 trillion won, and the domestic market is confirmed to be about 130 billion won.