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和譽(02256.HK)合作夥伴治療原發性免疫缺陷藥物完成臨牀3期試驗患者入組
阿思達克 11-05 09:09
和譽(02256.HK)公佈,其附屬上海和譽生物醫藥科技的合作夥伴X4 Pharmaceuticals已完成其主要候選藥物mavorixafor的註冊性臨牀3期試驗患者入組,用於治療經基因證實的WHIM(疣、低丙種球蛋白血癥、感染和骨髓增生異常綜合徵)綜合徵患者,這是一種由CXCR4基因功能突變引起的原發性免疫缺陷疾病,31名成人和兒童患者參加該4WHIM臨牀3期試驗。 該試驗將比較每日一次口服劑量的mavorixafor與安慰劑的主要和次要終點,包括臨牀相關的中性粒細胞和淋巴細胞計數、感染和疣發生的頻率和嚴重程度,以及特定的生活質量監測。該試驗最初設計爲招募18至28名患者。 Mavorixafor(ABSK081)是一款全球領先的first-in-class口服CXCR4拮抗劑。和譽醫藥已授權獲得mavorixafor在大中華地區腫瘤及WHIM適應症的商業化權益,並將主導其大中華地區多個腫瘤適應症的臨牀與商業開發,並已逐步開展多項mavorixofor與腫瘤免疫抑制劑或其它藥物聯合治療的臨牀研究。
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