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康哲藥業(00867.HK)創新藥XF-73鼻用凝膠海外IIb期臨牀研究取得積極結果
格隆匯 03-29 22:15

2021年3月29日,康哲藥業(00867.HK)合作伙伴Destiny Pharma宣佈,創新藥XF-73鼻用凝膠(主要用於預防術後金葡菌感染)海外IIb期臨牀研究取得積極頂線結果:

● 達到主要療效終點,鼻細菌負荷降低>99%(p<0.0001)

● 極佳的安全性特徵,無治療相關不良事件

該研究為一項多中心、雙盲、隨機、安慰劑對照研究,旨在多次應用單濃度XF-73鼻用凝膠,以評估XF-73對計劃接受外科手術的患者(這些患者術後金黃色葡萄球菌(“金葡菌”)感染的風險較高)共生金葡菌鼻定植的微生物學效應。

臨牀研究結果摘要

1. 達到主要終點:在micro-ITT(打算治療)人羣中,XF-73在術前24小時內使接受開胸心臟手術患者中金葡菌的平均鼻負荷降低2.5 log (CFU/ml),具有高度統計學意義(p<0.0001)。這相當於金葡菌鼻腔帶菌率降低99.5%,這是公認的臨牀措施實現的非常有效的降低。

2. XF-73顯示相同患者人羣中的降幅2.1 log(>99%)大於安慰劑,在micro-ITT和符合方案人羣中,金葡菌鼻負荷降低的差異具有高度統計學顯著性(p<0.0001)。且該效果在手術期間(被認為感染風險最高)得以維持。

3. 次要終點的初步分析顯示,XF-73治療組在術前24小時內金葡菌鼻負荷降低程度高於安慰劑組,當通過曲線下面積(AUC)和達到特定log降低的患者百分比進行分析時也觀察到這一點。

4. 在切口/手術開始前24小時,僅用0.2% (w/w) XF-73鼻用凝膠四次即可達到陽性結果。

5. 未發生與治療相關的不良事件。

目前,XF-73已被美國FDA授予合格感染疾病產品(QIDP)和快速通道(Fast Track)資格。Destiny Pharma目前計劃與監管機構(包括美國FDA)討論可行的III期臨牀研究設計。

關於產品

XF-73是具有抗菌活性的合成二價卟啉衍生物,其作用機制新穎,與現有的任何抗菌藥物家族都不同,主要通過影響細菌細胞膜的通透性和完整性的細菌表面機制起作用,從而導致細胞內成分釋放和細胞死亡,且無裂解。XF-73對所有測試的金葡菌包括耐甲氧西林金葡菌和多藥耐藥菌都有活性,具有快速殺菌且不易產生耐藥性的特點。其化合物和用途專利已在中國獲得授權。

普通人羣中,約三分之一為金葡菌攜帶者,且通常在鼻內,這部分人羣術後感染的風險顯著較高。中國細菌耐藥性監測結果亦表明,其在革蘭陽性球菌中佔第一位。WHO手術安全指南指出:金葡菌的鼻定植是術後感染的危險因素。然而,細菌耐藥嚴重限制了現有的預防性治療。相比之下,XF-73已被證明不會產生耐藥,且這種優越的特徵使其非常適合廣泛用於預防術後感染,可解決未被滿足的臨牀需求。

康哲藥業已於2017年對Destiny Pharma進行股權投資並獲得XF-73在中國等亞洲國家(不含日本)的特定資產權利。

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