君聖泰醫藥-B(02511.HK):熊去氧膽小檗礆(HTD1801)在2型糖尿病患者中開展的兩項3期臨牀試驗達到主要終點
格隆匯4月15日丨君聖泰醫藥-B(02511.HK)發佈公吿,公司自主研發的腸肝抗炎及代謝調節劑熊去氧膽小檗礆(HTD1801)在中國2型糖尿病(T2DM)患者中開展的兩項3期臨牀試驗(SYMPHONY 1和SYMPHONY 2)達成主要療效終點及多個次要療效終點。
這兩項3期臨牀試驗結果充分證明了HTD1801一藥多效、為T2DM患者提供綜合獲益的特性。基於此次發佈的積極的臨牀試驗數據,君聖泰醫藥計劃於今年內向國家藥品監督管理局(NMPA)藥品審評中心(CDE)遞交HTD1801治療T2DM適應症的新藥上市申請(NDA)。
SYMPHONY 1(NCT06350890)及SYMPHONY 2(NCT06353347)試驗是兩項多中心、隨機、雙盲、安慰劑平行對照的臨牀3期試驗,旨在分別評估HTD1801在飲食及運動干預後血糖控制不佳(SYMPHONY 1; N=407)和二甲雙胍控制不佳(SYMPHONY 2; N=549)的T2DM患者中的有效性和安全性。兩項研究的主要療效終點為與安慰劑相比,HTD1801治療24周後糖化血紅蛋白(HbA1c)相對於基線的變化,次要終點包含達到HbA1c <7.0%的受試者百分比、空腹血糖(FPG)、低密度脂蛋白膽固醇(LDL-C)、γ-谷氨酰轉移酶(GGT)和超敏C反應蛋白(hs-CRP)。
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