More than 360 patients dosed out of 400 patients in the US and Korea
MLR-1023, a new anti-diabetic drug from Bukwang Pharmaceutical, is scheduled to complete patients enrollment within this month. It is a global Ph 2b clinical trial of 400 patients in a total of 60 sites, 40 sites in the US and 20 sites in Korea. It is anticipated that the dosing for all patients will be completed in Nov, 4 months after the completion of patient enrollment.
It is such a rapid development speed that completing global Ph 2b study within 4 years after in-licensing a new drug candidate in 2013. In the meantime, we completed the chronic toxicity tests and obtained global coverage patents.
When MLR-1023 is launched, it is expected to reach the maximum annual sale of more than 3 trillion KRW, considering Januvia annual sales is 3,908 M USD, and Victoza sales is 2,983 M USD in 2016.
MLR-1023 is a new diabetic drug with a new mechanism of action. Study result of Ph2a clinical trial was published at the American Diabetes Association, which shows blood glucose lowering and weight loss effects, as well as a synergistic effect in combination with the existing anti-diabetic agents. It is anticipated to be a new drug that can be used according to the standard of care worldwide.