通化東寶(600867.SH)：URAT1抑制劑(THDBH130片)IIa期臨牀試驗達到主要終點
格隆匯1月16日丨通化東寶(600867.SH)公佈，全資子公司東寶紫星（杭州）生物醫藥有限公司完成了一項關鍵IIa期臨牀試驗並獲得臨牀試驗總結報吿，研究結果顯示達到主要終點目標。公司在獲得THDBH130片藥物臨牀試驗批准後，根據國內化學藥品創新藥相關指導原則，在2022年已經完成了一項“THDBH130片在健康成人受試者中單次和多次給藥的安全性、耐受性、藥代藥效動力學及食物影響的I期臨牀研究”，研究結果達到了主要終點目標，顯示THDBH130片具有良好的安全性及耐受性。基於本品臨牀I期研究結果和數據分析，公司啟動並完成了“一項在成人高尿酸血癥伴或不伴痛風患者中評價THDBH130片的安全性、耐受性、初步臨牀有效性及藥代/藥效動力學特徵的多中心、隨機、雙盲、安慰劑和苯溴馬隆對照IIa期臨牀研究”，並獲得此項臨牀試驗的總結報吿。
研究結果顯示達到了主要終點目標。有效性方面，THDBH130片可劑量依賴性地降低痛風患者的血尿酸水平，目標劑量下與陽性對照藥物苯溴馬隆相比，血尿酸6mg/dl的達標率相當，但4、5mg/dl的達標率有一定的優勢。安全性方面，本品具有良好的安全性及耐受性，所有藥物相關性不良事件均為輕度，沒有3級或3級以上的不良事件發生。目標劑量下不良事件發生率與苯溴馬隆相似或更低，且給藥期急性痛風發生率顯著降低。綜合本項研究數據結果，預期本品在血尿酸緩解深度以及部分複雜/難治性痛風患者中有潛在優勢。
在開展上述IIa期研究同時，公司同步開展並完成了一項“評價THDBH130片在腎功能正常和輕-中度腎功能不全的成年男性受試者中單次給藥的安全性、耐受性、藥代/藥效動力學特徵和碘海醇測定腎小球濾過率的I期臨牀研究”。研究結果顯示，本品對於不同腎功能水平患者的安全性沒有明顯差異，同時驗證了使用劑量下本品對於腎小球濾過率沒有影響。
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