April 27, 2024
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Bukwang to initiate phase 2 study of diabetes drug
[THE INVESTOR] South Korea’s Bukwang Pharmaceutical has filed an application with Korea Food & Drug Administration to initiate phases 2 clinical trials of its diabetes drug candidate, the drug maker said on Dec. 19.
MLR-1023 is an oral insulin sensitizer for the treatment of type 2 diabetes, jointly developed by the Korean company and US-based Melior Pharmaceuticals.
MLR-1023 is an oral insulin sensitizer for the treatment of type 2 diabetes, jointly developed by the Korean company and US-based Melior Pharmaceuticals.
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The phase 2b study is set to begin on patients who experienced insufficient improvement of blood sugar levels by taking existing oral diabetes medicine Metformin alone.
Bukwang and Melior will conduct the clinical trials at 60 clinical sites in the US and Korea from March 2017, according to the pharmaceutical company.
In June, the two firms said their phase 2a proof-of-concept study of MLR-1023 met its primary endpoint, lowering of post-prandial plasma glucose as evaluated in a mixed meal tolerance test, as well as several secondary endpoints including the lowering of fasting plasma glucose at a statistically significant level as per protocol design.
In 2013, Melior licensed MLR-1023 to Bukwang for the development and commercialization in Asian countries excluding Japan.
By Park Han-na (hnpark@heraldcorp.com)
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