Dive Brief:

潜水简介：

An experimental pill developed by Johnson & Johnson and Protagonist Therapeutics significantly cleared skin in most people with moderate-to-severe plaque psoriasis who enrolled in a Phase 3 trial run by J&J.

强生公司和Protation Therapeutics公司开发的一种实验性药丸能显著清除大多数中重度斑块状银屑病患者的皮肤，这些患者参加了强生公司的3期临床试验。

Treatment with the drug, called icotrokinra, led to clear or almost clear skin in about two-thirds of participants after four months of testing. Just under half experienced a 90% or greater reduction in their scores on another measure of psoriasis plaque coverage and severity. Only 8% and 4%, respectively, of study participants on placebo hit those same marks..

经过四个月的测试，大约三分之二的受试者服用了一种名为icotrokinra的药物，皮肤变得清澈或几乎清澈。在另一项衡量银屑病斑块覆盖率和严重程度的指标上，不到一半的人的得分降低了90%或更高。服用安慰剂的研究参与者中，只有8%和4%达到了同样的分数。。

Responses to icotrokinra improved further through six months and, according to a Monday statement from J&J, a similar percentage of participants in both trial groups experienced side effects. The company plans to present detailed results at an upcoming medical meeting.

六个月后，对icotrokinra的反应进一步改善，根据强生周一的一份声明，两个试验组的参与者中有相似比例的人出现了副作用。该公司计划在即将举行的医疗会议上公布详细结果。

Dive Insight:

潜水洞察：

Icotrokinra is the product of a research collaboration J&J and Protagonist struck just over seven years ago. It’s meant to match, or at least come close to, the effectiveness of injectable drugs now commonly used to treat inflammatory conditions like psoriasis, but with the convenience of being taken orally..

Icotrokinra是强生和Protactior七年前合作研究的产物。它意味着与目前常用于治疗牛皮癣等炎症性疾病的注射药物的有效性相匹配，或至少接近，但口服方便。。

Drugmakers the industry over have embarked on a similar mission, investing in medicines aimed at an array of enzymes and proteins that help control the body’s immune response.

整个行业的制药商也开始了类似的使命，投资于针对一系列酶和蛋白质的药物，这些酶和蛋白质有助于控制人体的免疫反应。

Icotrokinra takes aim at receptor known as IL-23, blocking the same signaling pathway as AbbVie’s fast-selling injection Skyrizi and J&J’s own Tremfya.

Icotrokinra的目标是被称为IL-23的受体，阻断了与AbbVie的畅销注射液Skyrizi和强生自己的Tremfya相同的信号通路。

The good news from Monday’s results, according to Leerink Partners’ David Risinger, is that icotrokinra’s efficacy seems “roughly comparable” to the older injectable drug Stelara and potentially “superior” to oral drugs like Sotyktu and Otezla that are approved for psoriasis.

据Leerink Partners的DavidRisinger称，周一的结果显示，icotrokinra的疗效似乎与较老的注射药物Stelara“大致相当”，并且可能“优于”批准用于牛皮癣的口服药物Sotyktu和Otezla。

However, the analyst wrote in a client note Tuesday, icotrokinra seems less effective than Skyrizi and Tremfya, which may limit its ability to directly replace those treatments.

然而，这位分析师在周二的一份客户报告中写道，icotrokinra似乎不如Skyrizi和Tremfya有效，这可能会限制其直接替代这些治疗的能力。

The main measures of success in J&J’s study, called ICONIC-LEAD, were improvements on the Investigator's Global Assessment, or IGA, and the Psoriasis Area and Severity Index, or PASI. Scores of 0 or 1 on IGA correspond to clear or nearly clear skin and, by week 24, 74% of icotrokinra-treated participants met that criteria..

强生研究成功的主要衡量标准是研究者的全球评估（IGA）和牛皮癣面积和严重程度指数（PASI）的改进。IGA评分为0或1对应于透明或接近透明的皮肤，到第24周，74%接受icotrokinra治疗的参与者符合该标准。。

PASI, by comparison, measures the total area of skin affected by psoriasis plaques, as well as how red and thick those plaques are. So-called PASI 90 refers to a 90% or greater improvement in PASI scores compared to baseline measurements. About half of the people on icotrokinra hit this threshold by week 16, and 65% did by week 24..

相比之下，PASI测量受牛皮癣斑块影响的皮肤总面积，以及这些斑块的红色和厚度。所谓的PASI 90是指与基线测量相比，PASI得分提高90%或更高。icotrokinra上大约一半的人在第16周达到了这个阈值，65%的人在第24周达到了这个阈值。。

Adjusted for placebo response rates through week 16, icotrokinra’s 45% rate on PASI 90 is well below the roughly 70% rate seen in trials of Skyrizi and Tremfya, according to Risinger.

根据Risinger的说法，调整到第16周的安慰剂反应率后，icotrokinra在PASI 90上的45%的反应率远低于Skyrizi和Tremfya试验中大约70%的反应率。

Still, Risinger expects J&J can eventually meet its forecast of greater than $5 billion in peak annual sales of icotrokinra, as he sees it helping expand the market share of IL-23 drugs.

尽管如此，Risinger预计强生公司最终可以达到其预计的年销售额超过50亿美元的高峰，因为他认为这有助于扩大IL-23药物的市场份额。

In addition to announcing data from ICONIC-LEAD, J&J also said that another Phase 3 study, ICONIC-TOTAL, succeeded, showing once-daily icotrokinra met its main goal on IGA compared to placebo by week 16.

。

Results from both studies will be included in approval applications J&J is now preparing.

这两项研究的结果将包括在强生目前正在准备的批准申请中。

The company is also testing its drug against Sotyktu, which is sold by Bristol Myers Squibb, in two Phase 3 trials of people with moderate-to-severe plaque psoriasis. Studies evaluating icotrokina in psoriatic arthritis are set to begin next year, while results from a Phase 2 test in ulcerative colitis are anticipated before June..

该公司还在针对百时美施贵宝（Bristol-Myers Squibb）销售的Sotyktu进行两项针对中度至重度斑块状银屑病患者的3期临床试验。评估银屑病关节炎中icotrokina的研究将于明年开始，而溃疡性结肠炎的2期测试结果预计将在6月之前得出。。

As a result of icotrokinra’s success in Phase 3, Protagonist has earned $165 million in milestone payments from J&J, which the biotechnology company said it expects to receive from J&J in the first quarter.

由于icotrokinra在第三阶段取得了成功，Protator从强生公司获得了1.65亿美元的里程碑式付款，这家生物技术公司表示，预计将在第一季度从强生公司获得这笔款项。