智通财经APP获悉,赛诺菲(SNY.US)与梯瓦(TEVA.US)日前公布了其共同开发的在研单抗duvakitug在2b期临床试验RELIEVE UCCD中获得的详细结果。试验结果显示,接受duvakitug治疗的溃疡性结肠炎(UC)和克罗恩病(CD)患者在第14周时达成缓解。新闻稿表示,这一结果展现了duvakitug成为“best-in-class”疗法的潜力。两家公司预计在今年下半年启动3期临床试验。
2b期临床试验数据显示,接受duvakitug治疗的UC患者中,36%的低剂量组和48%高剂量组患者实现临床缓解(clinical remission),此数值在安慰剂组仅为20%。经安慰剂校正后,低剂量组和高剂量组患者在第14周的临床缓解率分别为16%(p=0.050)和27%(p=0.003)。
此外,duvakitug组的临床应答(clinical response)率分别为81%(低剂量组)和70%(高剂量组),安慰剂组这一数值为52%。Duvakitug组的内镜改善率分别为45%(低剂量组)和50%(高剂量组),安慰剂组为23%。
在CD患者中,26%的低剂量组和48%的高剂量组患者达到内镜缓解的主要终点,此数值在安慰剂组为13%。经安慰剂校正后,低剂量组和高剂量组患者在第14周的内镜缓解率分别为13%(p=0.058)和35%(p<0.001)。
Duvakitug是一款潜在“best-in-class”的人源IgG1-λ2单抗,靶向TL1A。TL1A通过与其受体DR3结合,可放大炎症反应并加速IBD相关纤维化的进展。靶向TL1A有望缓解IBD患者的过度免疫反应。赛诺菲与梯瓦在2023年达成合作,共同开发并商业化duvakitug,用于治疗UC和CD。赛诺菲主导3期临床开发项目。梯瓦负责产品在欧洲、以色列及指定国家与地区的商业化推广,赛诺菲则负责北美、日本、其他亚洲地区及全球其他市场的商业化。
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