BRUSSELS, Belgium and CAMBRIDGE, Mass. – November 19, 2024 – UCB (Euronext Brussels: UCB) and Biogen Inc. (NASDAQ: BIIB) today presented detailed results from the Phase 3 PHOENYCS GO study evaluating dapirolizumab pegol (DZP), a novel Fc-free anti-CD40L drug candidate, demonstrating significant clinical improvement in disease activity in people living with moderate-to-severe systemic lupus erythematosus (SLE).

比利时布鲁塞尔和马萨诸塞州剑桥市。2024年11月19日，UCB（Euronext BRUSSELS:UCB）和Biogen Inc.（NASDAQ:BIIB）今天公布了PHOENYCS GO第三阶段研究的详细结果，该研究评估了达匹罗珠单抗聚乙二醇（DZP），一种新型无Fc的抗CD40L候选药物，证明中度至重度系统性红斑狼疮（SLE）患者的疾病活动有显着的临床改善。

The results were shared during an oral, late-breaker presentation at ACR Convergence 2024, the American College of Rheumatology’s annual meeting, in Washington, DC..

在华盛顿特区举行的美国风湿病学会年会ACR Convergence 2024上，这些结果在一次口头、迟发性的演讲中得到了分享。。

“There remains a significant unmet need for additional treatment options for people living with systemic lupus erythematosus and the results we observed in PHOENYCS GO suggest dapirolizumab pegol has the potential to be impactful for this chronic and debilitating autoimmune disease. Across clinical endpoints we observed a positive effect and a favorable safety profile,” said Megan E.B Clowse, M.D., principal investigator of the study and Associate Professor of Medicine, Chief of the Division of Rheumatology and Immunology at Duke University School of Medicine.

“对系统性红斑狼疮患者的额外治疗选择仍有很大的需求未得到满足，我们在PHOENYCS GO中观察到的结果表明，达匹单抗聚乙二醇可能对这种慢性和衰弱性自身免疫性疾病产生影响。在临床终点上，我们观察到了积极的效果和良好的安全性，”该研究的首席研究员兼杜克大学医学院风湿病和免疫学系主任医学副教授梅根·E·B·克罗斯（Megan E.B Clowse）医学博士说。

“Participants receiving dapirolizumab pegol experienced reduced lupus activity while also tapering steroids, changes important to people living with the disease.” .

“接受dapirolizumab pegol治疗的参与者经历了狼疮活动减少，同时类固醇也逐渐减少，这对患有这种疾病的人很重要。”。

In the PHOENYCS GO study (n=321), dapirolizumab pegol (DZP) was administered intravenously every four weeks. On the primary endpoint measuring improvement of moderate-to-severe disease activity as assessed by achievement of British Isles Lupus Assessment Group (BILAG)-based Composite Lupus Assessment (BICLA) after 48 weeks, study participants receiving DZP plus SOC had a statistically significant 14.6% (95% confidence interval [CI]: 3.3, 25.8; p=0.0110) higher response rate (49.5%) than those receiving SOC alone (34.6%).

在48周后通过基于不列颠群岛狼疮评估组（BILAG）的综合狼疮评估（BICLA）评估的中重度疾病活动改善的主要终点评估中，接受DZP加SOC的研究参与者的统计学显着性为14.6%（95%置信区间[CI]：3.3,25.8；p=0.0110）比单独接受SOC的患者（34.6%）更高的应答率（49.5%）。

A higher BICLA response rate reflects a treatment response across all affected organs at baseline and is associated with meaningful clinical benefit..

较高的BICLA反应率反映了基线时所有受影响器官的治疗反应，并与有意义的临床益处相关。。

On the first secondary endpoint of BICLA response at Week 24, study participants receiving DZP plus SOC had a 7.9% higher response rate (46.6%) than those receiving SOC alone (38.3%). However, the difference did not reach statistical significance (95% CI: -3.6, 19.4; p=0.1776). Given statistical significance was not achieved for the first key secondary endpoint in the hierarchical testing, analyses for all the subsequent secondary endpoints are descriptive and nominal p-values are included..

在第24周BICLA反应的第一个次要终点，接受DZP加SOC的研究参与者的反应率（46.6%）比单独接受SOC的参与者（38.3%）高7.9%。然而，差异没有达到统计学显着性（95%CI:-3.6,19.4；p=0.1776）。鉴于分层测试中第一个关键次要终点未达到统计学显着性，因此对所有后续次要终点的分析都是描述性的，并包括名义p值。。

Subsequent analyses of additional secondary endpoints showed clinical improvements in the DZP group, including SLE Responder Index (SRI)-4 response, corticosteroid tapering, SLE Disease Activity Index-2K (SLEDAI-2K), achievement of Lupus Low Disease Activity State (LLDAS) and prevention of severe BILAG flares: .

随后对其他次要终点的分析显示，DZP组的临床改善，包括SLE反应指数（SRI）-4反应，皮质类固醇逐渐减少，SLE疾病活动指数-2K（SLEDAI-2K），实现狼疮低疾病活动状态（LLDAS）和预防严重的BILAG耀斑：。

17.1% more participants receiving DZP were able to reduce their corticosteroid dose from >7.5 mg/day prednisone equivalent at baseline to ≤7.5 mg/day at Week 48 (72.4% vs. 52.9%; difference [95% CI]: 17.1% [0.7, 33.4]; nominal p=0.0404).

接受DZP治疗的参与者中，有17.1%的人能够在第48周时将皮质类固醇剂量从基线时的大于7.5毫克/天泼尼松当量减少到小于7.5毫克/天（72.4% vs. 52.9%；差异[95% CI]：17.1% [0.7，33.4]；标称P=0.0404）。

18.8% higher SRI-4 response rate at Week 48 (95% CI: 7.3, 30.3; nominal p=0.0014) among study participants who received DZP plus SOC (60.1%) versus those who received SOC alone (41.1%).

接受DZP加SOC（60.1%）的研究参与者与单独接受SOC（41.1%）的研究参与者相比，在第48周时SRI-4应答率高18.8%（95%CI:7.3,30.3；标称p=0.0014）。

A 1.8-fold greater decrease from baseline in SLEDAI-2K in study participants receiving DZP plus SOC compared to SOC alone at Week 48 (-6.1 vs –4.2; difference [95% CI]: -1.8 [-2.7, -0.9]; nominal p=0.0001).

在第48周，接受DZP加SOC的研究参与者的SLEDAI-2K与基线相比下降了1.8倍（-6.1 vs-4.2；差异[95%CI]：-1.8[-2.7，-0.9]；标称p=0.0001）。

A 20.9% greater proportion of participants in the DZP group achieved LLDAS at Week 48 compared to SOC alone (40.9% vs. 19.6%; difference [95% CI]: 20.9% [10.7,31.2]; nominal p<0.001).

与单独的SOC相比，DZP组参与者在第48周达到LLDAS的比例高出20.9%（40.9%比19.6%；差异[95%CI]:20.9%[10.7,31.2]；名义p＜0.001）。

Participants receiving DZP plus SOC had 50% fewer severe BILAG flares through Week 48 (95% CI: 1.4, 21.6; nominal p=0.0257) compared to SOC alone (11.6% vs. 23.4%).

与单独的SOC（11.6%比23.4%）相比，接受DZP加SOC的参与者在第48周的严重BILAG耀斑减少了50%（95%CI:1.4,21.6；标称p=0.0257）。

“Due to the varied symptoms and severity by patient, progress in the treatment of lupus has historically been challenging. With dapirolizumab pegol, we believe that our differentiated approach that targets the CD40L pathway results in clinically meaningful improvements across multiple disease domains and could substantially impact the burden of this disease in particular for women, who are disproportionately affected by lupus,” said Fiona du Monceau, Head of Patient Evidence at UCB.

“由于患者的症状和严重程度各不相同，狼疮治疗的进展在历史上一直具有挑战性。我们相信，针对CD40L通路的差异化方法可以在多个疾病领域带来临床上有意义的改善，并可能对这种疾病的负担产生重大影响，特别是对女性来说，她们受狼疮的影响不成比例，”UCB患者证据主管菲奥娜·杜蒙西奥（FionaduMonceau）说。

“We are highly encouraged by the results we have seen in PHOENYCS GO and are excited to continue the clinical development of dapirolizumab pegol in the second Phase 3 study, PHOENYCS FLY.” .

“我们对在PHOENYCS GO中看到的结果感到非常鼓舞，并很高兴在第二阶段3研究PHOENYCS FLY中继续dapirolizumab pegol的临床开发。”。

The safety profile of dapirolizumab pegol was generally favorable. The safety results were consistent with previous DZP studies and with that in study participants with SLE receiving an immunomodulator. In the PHOENYCS GO study, a higher proportion of patients receiving DZP plus SOC had treatment-emergent adverse events (TEAEs) compared to SOC alone (82.6% vs.

dapirolizumab pegol的安全性总体上是有利的。安全性结果与之前的DZP研究以及接受免疫调节剂的SLE研究参与者一致。在PHOENYCS GO研究中，与单独的SOC相比，接受DZP加SOC的患者中有更高比例的患者出现了治疗紧急不良事件（TEAE）（82.6%vs。

75.0%). The proportion of participants with serious TEAEs was 9.9% in those participants receiving DZP plus SOC compared 14.8% in those receiving SOC alone. Opportunistic infections were reported in 2.8% of participants receiving DZP plus SOC compared to 0.9% of those receiving SOC alone. Discontinuation of treatment or study participation due to TEAEs occurred in 4.7% (10) of participants receiving DZP plus SOC and 3.7% (4) of participants receiving SOC alone..

75.0%）。在接受DZP加SOC的参与者中，严重TEAE的参与者比例为9.9%，而仅接受SOC的参与者为14.8%。接受DZP加SOC的参与者中有2.8%报告了机会性感染，而仅接受SOC的参与者中有0.9%报告了机会性感染。4.7%（10）接受DZP加SOC的参与者和3.7%（4）仅接受SOC的参与者因TEAE而停止治疗或研究参与。。

“At Biogen, we understand that lupus affects everyone differently and are committed to developing treatments as diverse as the patients we serve,” said Diana Gallagher, MD, Head of AD, MS and Immunology Development Units at Biogen. “These results reinforce our belief that dapirolizumab pegol has the potential to change the approach to care of SLE and we are dedicated to advancing this program with our partner UCB.”.

“在Biogen，我们了解狼疮对每个人的影响都不同，并致力于开发与我们服务的患者不同的治疗方法，”Biogen AD，MS和免疫学发展部门负责人Diana Gallagher医学博士说。“这些结果强化了我们的信念，即dapirolizumab pegol有可能改变SLE的护理方法，我们致力于与我们的合作伙伴UCB一起推进这一计划。”。

Participants from the PHOENYCS GO study will continue to be followed in a long-term open-label study. In 2024, UCB and Biogen will initiate a second Phase 3 trial of dapirolizumab pegol, PHOENYCS FLY (NCT06617325).

PHOENYCS GO研究的参与者将继续接受长期的开放标签研究。2024年，UCB和Biogen将启动dapirolizumab pegol，PHOENYCS FLY（NCT06617325）的第二阶段3试验。

The safety and efficacy of dapirolizumab pegol in systemic lupus erythematosus have not been established, and it is not approved for use in systemic lupus erythematosus by any regulatory authority worldwide.

dapirolizumab pegol在系统性红斑狼疮中的安全性和有效性尚未确定，全球任何监管机构均未批准其用于系统性红斑狼疮。

About Systemic Lupus Erythematosus (SLE)

关于系统性红斑狼疮（SLE）

SLE is a chronic, multifactorial autoimmune disease that is caused by the activation of autoreactive T, B and antigen-presenting cells, resulting in manifestations across multiple organ systems with periods of illness or flares alternating with periods of inactivity.1 SLE can present itself in several ways including rash, arthritis, anemia, thrombocytopenia, serositis, nephritis, seizures or psychosis.2 SLE is associated with a greater risk of death from causes such as infection and cardiovascular disease..

SLE是一种慢性多因素自身免疫性疾病，由自身反应性T细胞，B细胞和抗原呈递细胞的激活引起，导致多器官系统的表现，伴有疾病期或不活动期交替发作。1 SLE可以以多种方式出现，包括皮疹，关节炎，贫血，血小板减少症，浆膜炎，肾炎，癫痫发作或精神病。2 SLE与感染和心血管疾病等原因导致的死亡风险更高有关。。

An estimated 90% of people living with lupus are women; most begin to see symptoms between the ages of 15-55.3,4,5 Individuals from populations of African, Hispanic, Asian and Native American descent are at a greater risk of earlier onset and more aggressive disease.6,7 Pregnancy in women with SLE is high risk, with higher maternal and fetal mortality and morbidity than the general population.8,9.

估计90%的狼疮患者是女性；大多数人在15-55岁之间开始出现症状。来自非洲，西班牙裔，亚洲人和美洲原住民血统的人群中，有更大的发病风险和更具侵略性的疾病[6,7]。SLE女性怀孕风险高，孕产妇和胎儿死亡率和发病率高于一般人群[8,9]。

About Dapirolizumab Pegol

关于达匹洛珠单抗

Dapirolizumab pegol is a novel investigational humanized Fc-free polyethylene glycol (PEG)-conjugated antigen-binding (Fab’) fragment. Dapirolizumab pegol inhibits CD40L signaling which has been shown to reduce B cell activation and autoantibody production, mitigate type 1 interferon (IFN) secretion, and attenuate T cell and antigen-presenting cell (APC) activation.10 Dapirolizumab pegol is presently in Phase 3 clinical development for the treatment of systemic lupus erythematosus (SLE) under a collaboration between UCB and Biogen.11 .

Dapirolizumab pegol是一种新型的研究性人源化无Fc聚乙二醇（PEG）偶联抗原结合（Fab'）片段。Dapirolizumab pegol抑制CD40L信号传导，CD40L信号传导已被证明可减少B细胞活化和自身抗体产生，减轻1型干扰素（IFN）分泌，并减弱T细胞和抗原呈递细胞（APC）的活化.10 Dapirolizumab pegol目前处于UCB和Biogen合作下治疗系统性红斑狼疮（SLE）的3期临床开发中。

About UCB

关于UCB

UCB, Brussels, Belgium (www.ucb.com) is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or of the central nervous system. UCB is listed on Euronext Brussels (symbol: UCB)..

比利时布鲁塞尔UCB（www.UCB.com）是一家全球生物制药公司，专注于发现和开发创新药物和解决方案，以改变患有严重免疫系统或中枢神经系统疾病的人的生活。UCB在布鲁塞尔泛欧交易所上市（代码：UCB）。。

About Biogen

关于Biogen

Founded in 1978, Biogen is a leading biotechnology company that pioneers innovative science to deliver new medicines to transform patient’s lives and to create value for shareholders and our communities. We apply deep understanding of human biology and leverage different modalities to advance first-in-class treatments or therapies that deliver superior outcomes.

Biogen成立于1978年，是一家领先的生物技术公司，开创了创新科学，提供新药来改变患者的生活，并为股东和我们的社区创造价值。我们应用对人类生物学的深刻理解，并利用不同的方式来推进一流的治疗或治疗，从而取得优异的效果。

Our approach is to take bold risks, balanced with return on investment to deliver long-term growth..

我们的方法是大胆承担风险，并与投资回报率相平衡，以实现长期增长。