Daewoong Pharmaceutical "Confirmed Efficacy of New Diabetes Drug in Phase 3 Clinical Trial, Launching Next Year"

[Asia Economy Reporter Seo So-jung] Daewoong Pharmaceutical (CEO Jeon Seung-ho and Lee Chang-jae) announced on the 14th that the diabetes treatment candidate substance 'Inavogliflozin' confirmed its efficacy and safety in a Phase 3 clinical trial testing both monotherapy and combination therapy with the standard drug 'Metformin'.

Inavogliflozin is a new SGLT-2 inhibitor diabetes treatment drug being developed by Daewoong Pharmaceutical, the first among domestic pharmaceutical companies. Daewoong Pharmaceutical disclosed these topline results on the same day.

The Phase 3 monotherapy clinical trial was conducted as a multicenter, randomized, double-blind, placebo-controlled, therapeutic confirmation study involving a total of about 160 patients with type 2 diabetes. The principal investigator was Professor Park Kyung-soo of Seoul National University Hospital, along with research teams from 22 other institutions.

As a result of confirming the primary endpoint, the difference in the change of glycated hemoglobin (HbA1c) between the Inavogliflozin treatment group and the placebo group at 24 weeks after administration of the investigational drug was 0.99 percentage points, achieving statistical significance. Glycated hemoglobin is formed when hemoglobin is exposed to high blood glucose levels and is used as an indicator of average blood sugar, directly related to diabetic complications.

The Phase 3 results of combination therapy with Inavogliflozin and Metformin were also obtained. The Metformin combination clinical trial was conducted with about 200 patients with type 2 diabetes whose blood sugar control was insufficient with Metformin alone. The principal investigator was Professor Yoon Gun-ho of Seoul St. Mary's Hospital, along with research teams from 23 other institutions.

Based on the change in glycated hemoglobin, the non-inferiority of the combination therapy of Inavogliflozin and Metformin was demonstrated compared to the group treated with Dapagliflozin and Metformin. Additionally, the company explained that no significant adverse reactions or drug interactions were found when taking Inavogliflozin and Metformin together, confirming safety.

With meaningful results secured in both monotherapy and Metformin combination therapy clinical trials, Daewoong Pharmaceutical is set to be the first domestic pharmaceutical company to launch a new SGLT-2 inhibitor drug. Daewoong Pharmaceutical plans to soon apply for product approval and simultaneously launch both Inavogliflozin monotherapy and Metformin combination products by 2023.

Jeon Seung-ho, CEO of Daewoong Pharmaceutical, said, "With the success of this clinical trial, we expect the day will soon come when we can prescribe the best-in-class domestic new drug for diabetes to patients in Korea."

This content was produced with the assistance of AI translation services.