康諾亞-B(02162.HK)：CM310 IIb期臨牀研究獲得積極數據
格隆匯11月29日丨康諾亞-B(02162.HK)宣佈，其自主研發的1類新藥CM310重組人源化單克隆抗體注射液IIb期臨牀研究(CM310AD002)已完成數據揭盲及初步統計分析，獲得積極數據結果。CM310AD002是一項多中心、隨機、雙盲、安慰劑對照的IIb期研究，主要用於評價不同劑量CM310治療中重度特應性皮炎(AD)受試者的有效性、安全性、PK特徵、PD效應以及免疫原性。符合入排標準的受試者以1:1:1的比例隨機分配，分別接受CM310高劑量(600-300mg，Q2W)、低劑量(300-150mg，Q2W)和安慰劑治療8次，主要終點為治療16周時達到濕疹面積及嚴重指數(EASI)-75(EASI評分較基線降低≥75%)的受試者百分比。
研究結果顯示，此次CM310 IIb期臨牀研究，各劑量組主要終點均完全達標。在治療16周時，高劑量組達到EASI-75的受試者百分比為73.1%，低劑量組為70.6%，皆顯著優於安慰劑組的18.2%，P值均<0.0001。
在研究者總體評估(IGA)指標方面，高劑量組、低劑量組和安慰劑組在治療16周時達到IGA為0或1分(IGA 0/1，即皮損完全清除或基本清除)的受試者百分比分別為34.6%、32.4%和9.1%，兩個劑量組皆顯著優於安慰劑組，P值分別為0.023和0.033；高劑量組、低劑量組和安慰劑組在治療16周時IGA評分較基線下降≥2分的受試者百分比分別為53.8%、61.8%和9.1%，兩個劑量組皆顯著優於安慰劑組，P值均<0.0001。
兩個劑量組在其他療效相關指標如EASI-90、EASI-50、瘙癢數字評估量表(NRS)、特應性皮炎累及的體表面積(BSA)、皮膚病生活質量指數(DLQI)均在第16周觀察到顯著優於安慰劑組的效果。
同時，此次研究還觀察到CM310有良好的安全性特徵。高劑量組、低劑量組和安慰劑組的治療期間與研究藥物相關的治療期間不良事件(TEAE)發生率分別為20.0%、12.5%和12.5%，均為1或2級。
基於上述IIb期臨牀數據，我們將迅速推進CM310 III期臨牀試驗，進一步評估CM310在解決AD患者未滿足的治療需求方面所發揮的作用，希冀早日惠及更多患者。此外，公司也正在推動CM310在其它的適應症中的臨牀研究，包括慢性鼻竇炎伴鼻息肉和哮喘。
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