一品紅(300723.SZ):AR882項目研發進度正在按照計劃推進
格隆匯5月30日丨有投資者在投資者互動平台向一品紅(300723.SZ)提問,“貴司AR882原研藥臨牀試驗5月底結果是否出來?”
公司回覆稱,AR882項目研發進度正在按照計劃推進。2023年1月6日,公司自願披露了AR882取得治療痛風適應症的全球Ⅱb期臨牀試驗結果,結果顯示患者血清尿酸情況得到了顯著改善。Ⅱb期試驗為全球多中心、為期12周的隨機、雙盲、安慰劑對照試驗,共招募140名痛風患者入組,按1:1:1分組接受AR882 50 mg、AR882 75 mg 及安慰劑。病人患者入組sUA平均基線約為512μmol/L,75mg劑量組中位sUA降低至約208μmol/L,降低了約304μmol/L;50mg劑量組中位sUA降低至約297μmol/L,降低了約215μmol/L,安慰劑組中未觀察到變化。第8至12周最後3次連續隨訪的測試結果顯示,50mg和75mg劑量組顯著的降尿酸效果均呈現組內一致性。安慰劑組未顯示出療效。本次試驗所展現的良好的有效性和安全性結果,為其進入全球臨牀Ⅲ期提供了堅實的基礎。
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