Pictured: Person undergoing an eye exam/iStock, Jacob Wackerhausen

图为：接受眼科检查的人/伊斯托克，雅各布·瓦克豪森

Roivant has chalked up a mid-stage victory for its Pfizer-partnered dual TYK2/JAK1 inhibitor, setting it up to start a Phase III trial in non-anterior non-infectious uveitis this year.

Roivant公司与辉瑞公司合作的双重TYK2/JAK1抑制剂取得了中期胜利，今年将启动非前部非感染性葡萄膜炎的III期试验。

The oral drug candidate, brepocitinib, was one of the assets Pfizer transferred to Roivant’s Priovant Therapeutics in 2022. Brepocitinib targets TYK2, the receptor hit by Bristol Myers Squibb’s Sotyktu (deucravacitinib), and its sibling JAK1. Roivant is already testing the asset in a Phase III trial and ran the non-anterior non-infectious uveitis (NIU) study to learn whether to add a second pivotal program..

口服候选药物brepocitinib是辉瑞公司于2022年转让给Roivant Priovant Therapeutics的资产之一。Brepocitinib靶向TYK2，这是由百时美施贵宝的Sotyktu（deucravacitinib）及其兄弟JAK1击中的受体。Roivant已经在III期试验中测试了该资产，并进行了非前部非感染性葡萄膜炎（NIU）研究，以了解是否需要添加第二个关键程序。。

Investigators randomized 26 subjects with active NIU to receive 45mg or 15mg of brepocitinib once daily. Two thirds of the participants received the higher dose. All participants received a 60mg-a-day burst of prednisone for two weeks and were tapered off the steroid by week eight.

研究人员将26名患有活动性NIU的受试者随机分组，每天一次接受45mg或15mg的brepocitinib。三分之二的参与者接受了较高的剂量。所有参与者每天服用60mg泼尼松，持续两周，并在第八周逐渐减少类固醇。

The primary endpoint looked at the rate of treatment failure, a registrational composite measure of ocular inflammation, visual acuity, and discontinuation because of intercurrent events or the initiation of rescue therapy. After 24 weeks, the rate of treatment failure was 29% and 44%, respectively, in the high and low dose cohorts..

主要终点研究了治疗失败率，这是一种眼部炎症，视力和因并发事件或开始抢救治疗而停药的注册综合指标。24周后，高剂量组和低剂量组的治疗失败率分别为29%和44%。。

Those figures compare favorably to the Phase III data that AbbVie used to support approval of Humira  (adalimumab) in the indication in 2016. Across two late-phase trials, both of which enrolled more than 200 patients, AbbVie reported Humira treatment failure rates of 54.5% and 39.1%, respectively. The failure rates in the placebo cohorts were 78.5% and 55.0%, respectively..

这些数字与2016年AbbVie用于支持Humira（阿达木单抗）在适应症中获得批准的III期数据相比是有利的。在两项招募了200多名患者的晚期试验中，AbbVie报告Humira治疗失败率分别为54.5%和39.1%。安慰剂组的失败率分别为78.5%和55.0%。。

AbbVie generated its results in much larger studies that were different than Roivant’s trial in some ways, such as the length of the steroid taper period. The differences mean comparisons of the results of the clinical trials may be unreliable. With that caveat, Roivant’s results look competitive and brepocitinib is given orally, making it potentially more convenient than the injectable Humira..

AbbVie在更大的研究中得出了其结果，这些研究在某些方面与Roivant的试验不同，例如类固醇减量期的长度。差异意味着临床试验结果的比较可能不可靠。有了这个警告，Roivant的结果看起来很有竞争力，brepocitinib是口服的，这可能比注射用Humira更方便。。

Roivant’s trial also met its week 24 secondary efficacy endpoints, including assessments of haze grades, visual acuity and macular thickness. Macular edema resolved by week 24 in 43% of participants in the 45mg arm who had the condition at baseline.

Roivant的试验也达到了第24周的次要疗效终点，包括评估雾霾等级、视力和黄斑厚度。45mg组中有43%的参与者在基线时出现黄斑水肿，到第24周时黄斑水肿消退。

Safety and tolerability were consistent with prior clinical trials of brepocitinib, Roivant said. The biotech reported no new safety or tolerability signals. The safety profile of brepocitinib across studies to date is consistent with JAK inhibitors, a widely prescribed class of products that carries a black box warning..

Roivant说，安全性和耐受性与之前的brepocitinib临床试验一致。该生物技术公司没有报告新的安全性或耐受性信号。迄今为止，brepocitinib在各项研究中的安全性与JAK抑制剂一致，JAK抑制剂是一种广泛处方的产品，带有黑匣子警告。。

Roivant is sufficiently encouraged by the results to commit to running a late-stage trial in the indication. A Phase III trial in NIU is scheduled to start in the second half of 2024. The biotech expects to report pivotal data in dermatomyositis next year.

结果充分鼓励Roivant致力于在适应症中进行后期试验。计划于2024年下半年在纽卡斯尔进行第三阶段试验。该生物技术公司预计明年将报告皮肌炎的关键数据。

The company disclosed the data alongside details of a $1.5 billion share buyback. Roivant will use $648 million to repurchase the entire Sumitomo Pharma stake. Sumitomo invested in Roivant in 2019.

该公司披露了这些数据以及15亿美元回购股份的细节。Roivant将斥资6.48亿美元回购住友制药的全部股份。住友于2019年投资了Roivant。

Nick Paul Taylor is a freelance pharmaceutical and biotech writer based in London. He can be reached on LinkedIn.

尼克·保罗·泰勒（NickPaulTaylor）是一位自由职业的制药和生物技术作家，总部位于伦敦。可以通过LinkedIn联系到他。