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On Monday,
周一,
Incyte Corporation
Incyte公司
INCY
incy
released topline results from its pivotal Phase 3 STOP-HS clinical trial program of povorcitinib, an oral small-molecule JAK1 inhibitor, in adult patients (≥18 years) with moderate to severe
发布了其关键的3期STOP-HS临床试验项目中关于povorcitinib(一种口服小分子JAK1抑制剂)的顶线结果,该试验针对中度至重度成年患者(≥18岁)。
hidradenitis suppurativa (HS)
化脓性汗腺炎(HS)
.
。
Hidradenitis suppurativa (HS), also known as acne inversa, is a chronic inflammatory skin condition characterized by painful, recurrent boil-like lumps, often in areas where skin rubs together like the armpits and groin, that can lead to abscesses and scarring.
化脓性汗腺炎(HS),也称为反向痤疮,是一种慢性炎症性皮肤病,特征是疼痛、反复出现的类似疖子的肿块,常见于皮肤相互摩擦的部位,如腋窝和腹股沟,可能导致脓肿和疤痕。
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STOP-HS1 and STOP-HS2 studies met their primary endpoint at both tested doses (45 mg and 75 mg).
STOP-HS1 和 STOP-HS2 研究在两种测试剂量(45 毫克和 75 毫克)下均达到了主要终点。
A significantly higher proportion of patients treated with povorcitinib once daily versus placebo achieved Hidradenitis Suppurativa Clinical Response (HiSCR), a ≥50% reduction from baseline in the total abscess and inflammatory nodule count (AN count), with no increase from baseline in abscess or
与安慰剂相比,每日一次接受povorcitinib治疗的患者中,有显著更高比例的患者达到了化脓性汗腺炎临床反应(HiSCR),即从基线开始总脓肿和炎性结节数量(AN计数)减少了≥50%,且脓肿或炎性结节没有从基线增加。
draining tunnel count
排水隧道数量
.
。
The percentage of povorcitinib treated patients achieving HiSCR50 compared to placebo at Week 12 was:
第12周时,与安慰剂相比,达到HiSCR50的povorcitinib治疗患者百分比为:
STOP-HS1: 45 mg: 40.2% vs. 29.7% [
STOP-HS1: 45 mg: 40.2% vs. 29.7% [
P
P
=0.024]; 75 mg: 40.6% vs 29.7% [
=0.024];75毫克:40.6% 对 29.7% [
P
P
=0.022].
=0.022]。
STOP-HS2: 45 mg: 42.3% vs. 28.6% [
STOP-HS2:45毫克:42.3% 对比 28.6% [
P
P
=0.004]; 75 mg: 42.3% vs. 28.6% [
=0.004];75毫克:42.3% 对 28.6% [
P
P
=0.003].
=0.003]。
Within a predefined subgroup of patients previously exposed to biologics, povorcitinib demonstrated greater differential efficacy (HiSCR50) when compared to placebo:
在预先定义的曾接受过生物制剂治疗的患者亚组中,povorcitinib显示出比安慰剂更高的差异疗效(HiSCR50):
STOP-HS1: 45 mg: 34.2% vs. 21.9% [
STOP-HS1: 45 mg: 34.2% vs. 21.9% [
P
P
=0.096]; 75 mg: 37.8% vs. 21.9% [
=0.096];75毫克:37.8% 对比 21.9% [
P
P
=0.037].
=0.037]。
STOP-HS2: 45 mg: 45.0% vs. 19.5% [
STOP-HS2: 45 mg: 45.0% vs. 19.5% [
P
P
=0.001]; 75 mg: 40.0% vs. 19.5% [
=0.001];75毫克:40.0% vs. 19.5% [
P
P
=0.005].
=0.005]。
In addition, at Week 12, patients treated with povorcitinib achieved deep levels of clinical response with a greater proportion achieving HiSCR75, reduction in flares, >3-point decrease in the Skin Pain Numeric Rating Scale (NRS) score and Skin Pain NRS30.
此外,在第12周时,接受povorcitinib治疗的患者达到了深度临床反应水平,更大比例的患者实现了HiSCR75、病情复发减少、皮肤疼痛数字评分量表(NRS)评分降低超过3分以及皮肤疼痛NRS30。
Furthermore, povorcitinib demonstrated rapid onset of response, including rapid skin pain reduction.
此外,povorcitinib 还表现出快速起效的特点,包括迅速减轻皮肤疼痛。
The overall safety profile of povorcitinib is consistent with previous data. No new safety signals were observed and both doses were well tolerated.
Povorcitinib 的整体安全性与之前的数据一致。未观察到新的安全信号,两个剂量均耐受良好。
Last week,
上周,
Incyte
因赛特(Incyte)
revealed results from its pivotal Phase 3 TRuE-PN clinical trial program –TRuE-PN1 and TRuE-PN2 studies – evaluating the safety and efficacy of twice-daily ruxolitinib cream 1.5% (Opzelura) in adult patients with prurigo nodularis, a chronic skin condition characterized by
公布了其关键的3期TRuE-PN临床试验项目的结果——即TRuE-PN1和TRuE-PN2研究——评估了每日两次使用1.5%鲁索替尼乳膏(Opzelura)在患有结节性瘙痒症的成年患者中的安全性和有效性,结节性瘙痒症是一种以以下特征为表现的慢性皮肤病:
very itchy firm lumps
非常痒的硬块
.
。
Price Action:
价格行为:
INCY stock is down 11.90% at $59.78 at the last check Monday.
INCY股票在周一最后一次检查时下跌了11.90%,至59.78美元。
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INCY
再鼎医药
Incyte Corp
Incyte公司
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