科笛-B新药CU-20401 II期临床获显著疗效数据

财中社
29 Nov 2024

  科笛-B(02487)发布公告,宣布其潜在1类新药CU-20401(重组突变胶原酶)在中国开展的II期临床试验已获得顶线数据,且达到了主要研究终点,结果具有统计学显著性及临床意义。该临床试验为多中心、随机、双盲及安慰剂对照试验,共入组108例受试者,分析显示低剂量和高剂量CU-20401组的治疗有效率均高于安慰剂对照组,且有效率差异具有统计学意义。

  在安全性方面,CU-20401组未发生严重不良事件,整体展现出显著且稳健的疗效优势,安全性良好。CU-20401的作用机制为选择性作用于附着在脂肪组织上的细胞外基质,预期能有效减少局部脂肪堆积。公司提醒股东及潜在投资者在买卖股份时需审慎行事,因无法确保最终成功开发及销售CU-20401。

(文章来源:财中社)

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