Gilead Sciences, Inc. (Nasdaq: GILD) today announced new data from multiple analyses which reinforce that Livdelzi

吉利德科学公司（纳斯达克股票代码：GILD）今天宣布了多项分析的新数据，这些数据进一步证实了Livdelzi的效果。

（seladelpar），商品名为Lyvdelziin the European Union, is effective and generally well-tolerated for the treatment of primary biliary cholangitis (PBC) and also provides sustained biochemical response in adults with PBC regardless of prior treatment history. Another analysis provides evidence supporting that Livdelzi delivered clinically and statistically significant improvements in pruritus.

（seladelpar），商品名为Lyvdelzi在欧盟，对原发性胆汁性胆管炎（PBC）的治疗有效且通常耐受性良好，并且无论既往治疗史如何，它都能为成人PBC患者提供持续的生化反应。另一项分析提供了证据，表明Livdelzi在瘙痒方面带来了临床和统计学上显著的改善。

These data and more were presented at the European Association for the Study of the Liver (EASL) Congress 2025 in Amsterdam, Netherlands, from May 7–10..

这些数据及更多内容于 2025 年 5 月 7 日至 10 日在荷兰阿姆斯特丹举行的欧洲肝病研究协会 (EASL) 大会上公布。

Livdelzi Efficacy in Participants with Prior Fibrate or Obeticholic Acid Use

Livdelzi 在既往使用过贝特类药物或奥贝胆酸的参与者中的疗效

An interim analysis from ASSURE (

来自ASSURE的中期分析（

NCT03301506), an ongoing, open-label, long-term study, reinforces the efficacy and safety profile of Livdelzi in people with PBC, including those with prior fibrate or obeticholic acid use. This analysis assesses participants from the pivotal Phase 3 placebo-controlled RESPONSE (

NCT03301506），一项持续进行的、开放标签的长期研究，进一步证实了Livdelzi在原发性胆管炎（PBC）患者中的有效性和安全性，包括那些之前使用过贝特类药物或奥贝胆酸的患者。本分析评估了来自关键的第三阶段安慰剂对照RESPONSE研究的参与者（

NCT04620733) study and after participant rollover into the open-label ASSURE study, with or without prior fibrate or obeticholic acid use.

NCT04620733）研究以及参与者转入开放标签的ASSURE研究后，无论之前是否使用过贝特类药物或奥贝胆酸。

Among those with 18 months of exposure to Livdelzi, including 12 months in RESPONSE and 6 months in ASSURE, 60% (9/15) of participants with prior fibrate or obeticholic acid use achieved the composite biochemical response, as compared to 62% (54/87) of those without prior fibrate or obeticholic acid use.

在接触利维德尔齐18个月的参与者中，包括在RESPONSE研究中的12个月和在ASSURE研究中的6个月，先前使用过贝特类药物或奥贝胆酸的参与者中有60%（9/15）达到了综合生化反应，而未使用过贝特类药物或奥贝胆酸的参与者中这一比例为62%（54/87）。

Among participants who started Livdelzi in ASSURE after previously receiving placebo in RESPONSE, 64% (7/11) of participants with prior fibrate or obeticholic acid use, as compared to 78% (32/41) of participants without prior fibrate or obeticholic acid use achieved the composite biochemical response after 6 months of receiving Livdelzi (Month 6 of ASSURE).

在ASSURE试验中，此前在RESPONSE试验中接受安慰剂的参与者开始使用Livdelzi后，有既往使用贝特类药物或奥贝胆酸的参与者中有64%（7/11）在使用Livdelzi六个月（ASSURE试验的第6个月）后达到了复合生化反应，而无既往使用贝特类药物或奥贝胆酸的参与者中这一比例为78%（32/41）。

Safety was similar regardless of prior fibrate or obeticholic acid use. No treatment-related serious adverse events (SAEs) were reported..

无论之前是否使用过贝特类药物或奥贝胆酸，安全性都相似。没有报告与治疗相关的严重不良事件（SAEs）。

“Building on the momentum of Livdelzi’s launch, these new data presented at EASL further reinforce its potential as a meaningful treatment option for people living with PBC,” said Dietmar Berger, MD, PhD, Chief Medical Officer, Gilead Sciences. “We are particularly encouraged by the sustained biochemical response seen with Livdelzi, even among those who previously received fibrates or obeticholic acid.

“在Livdelzi上市的势头基础上，这些在EASL上公布的新数据进一步证实了它作为PBC患者有意义治疗选择的潜力，”Gilead Sciences首席医学官Dietmar Berger博士说道。“我们特别受到Livdelzi持续生化反应的鼓舞，尤其是在那些之前接受过贝特类药物或奥贝胆酸治疗的患者中。”

These results strengthen the evidence supporting Livdelzi’s efficacy and tolerability across a broad population of patients, including those seeking alternatives to current therapies. We remain focused on addressing significant unmet needs and driving progress in liver health.”.

这些结果加强了支持 Livdelzi 在广泛患者群体中有效性和耐受性的证据，包括那些寻求当前疗法替代方案的患者。我们仍然专注于解决显著未满足的需求，并推动肝脏健康领域的进展。"

Livdelzi and Meaningful Change in Pruritus

利夫德尔齐与瘙痒症的有意义变化

Up to 80% of people with PBC experience symptoms such as pruritus (chronic itch) and fatigue, both of which can profoundly compromise quality of life. The Pruritus Numeric Rating Scale (NRS) can evaluate treatment effects to see if a therapy is working, as well as examine the meaningful within-person change (MWPC) in the Pruritus NRS that people with PBC with pruritus perceive as a beneficial treatment effect.

高达80%的原发性胆汁性胆管炎（PBC）患者会出现诸如瘙痒（慢性瘙痒）和疲劳等症状，这两种症状都可能严重影响生活质量。瘙痒数字评分量表（NRS）可以评估治疗效果以判断一种疗法是否有效，并且可以检查PBC患者在瘙痒NRS中有意义的个体内部变化（MWPC），这种变化被患者感知为有益的治疗效果。

Using anchor-based analyses, a new study of the qualitative data from the participants of the RESPONSE trial with moderate-to-severe pruritus (NRS ≥ 4) at baseline (n=72) provides evidence supporting that Livdelzi delivered clinically and statistically significant improvements in pruritus..

基于锚定分析，一项针对RESPONSE试验中基线时中度至重度瘙痒（NRS ≥ 4）参与者（n=72）的定性数据的新研究提供了证据，支持Livdelzi在瘙痒方面实现了临床和统计学上的显著改善。

Results demonstrated that MWPC estimates of ≥ 3-points on the Pruritus NRS corresponded to “moderate improvement” as validated by PGI-C and 1-category improvement for PGI-S anchors. The data overall, including half of those interviewed (n=6/12), suggest a 3-point improvement in Pruritus NRS, as seen with seladelpar in the RESPONSE study, is a meaningful change.

结果表明，MWPC 估计的瘙痒 NRS ≥ 3 分对应于经 PGI-C 验证的“中度改善”以及 PGI-S 标准的 1 类别改善。总体数据（包括一半的受访者，n=6/12）表明，瘙痒 NRS 提高 3 分（如 RESPONSE 研究中 seladelpar 所显示的）是一项有意义的变化。

These findings highlight the potential of Livdelzi to address this debilitating symptom..

这些研究结果突显了 Livdelzi 解决这一衰弱症状的潜力。

NRS scores were measured against two anchor analyses, the 7-day recall Patient Global Impression of Severity of pruritus (PGI-S) and the Patient Global Impression of Change of pruritus (PGI-C), which were administered at study visits. The MWPC threshold estimates were validated using distribution-based methods and empirical cumulative distribution function (eCDF) curves.

NRS评分通过两项锚定分析进行测量，即7天回顾性患者整体瘙痒严重程度印象（PGI-S）和患者整体瘙痒变化印象（PGI-C），这两项分析在研究访视时进行。MWPC阈值估计通过基于分布的方法和经验累积分布函数（eCDF）曲线进行了验证。

Additionally, previously collected qualitative interviews were used to evaluate meaningful change on the Pruritus NRS in people with PBC with pruritus (NRS≥ 4) outside of the trial..

此外，之前收集的定性访谈被用于评估试验之外的PBC伴有瘙痒（NRS≥4）患者在瘙痒NRS上的有意义变化。

“Seladelpar is uniquely positioned as the only once-daily oral treatment that has statistically significant outcomes for both the underlying disease and the burdensome symptom of pruritus in people with PBC,” said Alejandra Maria Villamil, MD, Chief of Autoimmune Liver Diseases Unit Hospital Italiano de Buenos Aires Buenos Aires, Argentina.

“Seladelpar 是唯一一种每日一次的口服治疗药物，在改善 PBC 患者的基础疾病和令人困扰的瘙痒症状方面均显示出具有统计学意义的疗效，”阿根廷布宜诺斯艾利斯意大利医院自身免疫性肝病科主任 Alejandra Maria Villamil 医学博士表示。

“The demonstrated improvement in pruritus, combined with its established safety and efficacy profile, reinforces seladelpar as an on-label treatment option for people with PBC.”.

“Seladelpar在缓解瘙痒方面的显著改善，加上其已确立的安全性和有效性，进一步巩固了它作为PBC患者适应症内治疗选择的地位。”

Expanding Global Access for the Treatment of PBC in EEA

扩大PBC治疗在欧洲经济区的全球准入

Recently, the European Commission (EC) granted conditional marketing authorization for Lyvdelzi (seladelpar) for the treatment of PBC in combination with UDCA in adults who have an inadequate response to UDCA alone, or as monotherapy in those unable to tolerate UDCA. Lyvdelzi (an orphan designated product) provides an important treatment option for people living with the rare liver disease in the European Economic Area (EEA).

近日，欧洲委员会（EC）授予Lyvdelzi（seladelpar）有条件上市许可，用于与UDCA联合治疗对单用UDCA反应不佳的成人PBC患者，或作为无法耐受UDCA患者的单药治疗。Lyvdelzi（一种孤儿药指定产品）为欧洲经济区（EEA）内患有这种罕见肝病的人群提供了重要的治疗选择。

Gilead is working with health authorities across Europe to ensure people living with PBC who are eligible for seladelpar have access as soon as possible. Lyvdelzi has been granted conditional marketing authorization in the EU. Continued approval of Lyvdelzi for the approved indication may be contingent on verification and description of clinical benefit in confirmatory trial(s)..

吉利德正与欧洲各国卫生当局合作，以确保符合条件的原发性胆汁性胆管炎（PBC）患者尽快获得塞拉德帕。Lyvdelzi 已在欧盟获得附条件上市许可。Lyvdelzi 针对已批准适应症的持续批准可能取决于在确证性试验中对临床益处的验证和描述。

Outside of the EEA, Livdelzi was granted accelerated approval by the U.S. Food and Drug Administration (FDA) in August 2024 and conditional approval by the UK Medicines and Healthcare products Regulatory Agency (MHRA) in January 2025.

2024年8月，利夫德尔齐获得美国食品药品监督管理局（FDA）的加速批准，并于2025年1月获得英国药品和健康产品管理局（MHRA）的有条件批准。

Regulatory review for Livdelzi is also underway in Canada and Australia.

Livdelzi在加拿大和澳大利亚的监管审查也在进行中。

About ASSURE (NCT03301506)

关于ASSURE（NCT03301506）

ASSURE is an open-label, long-term study to evaluate the safety and tolerability of Livdelzi in people with primary biliary cholangitis (PBC). who have already participated in other PBC clinical trials of Livdelzi. The ASSURE study includes participants from previous studies of Livdelzi in PBC, including the Phase 3 registrational RESPONSE study and legacy clinical trials.

ASSURE 是一项开放标签、长期研究，旨在评估 Livdelzi 在原发性胆汁性胆管炎 (PBC) 患者中的安全性和耐受性，这些患者已参与过其他 Livdelzi 的 PBC 临床试验。ASSURE 研究包括之前参与过 Livdelzi 在 PBC 中的研究的参与者，包括三期注册性 RESPONSE 研究和以往的临床试验。

Legacy studies include the open label Phase 2 dose-ranging study (2 mg, 5 mg, or 10 mg Livdelzi), the open label Phase 3/4 long-term safety study (5 mg or 10 mg Livdelzi), the Phase 3 placebo-controlled ENHANCE study (5 mg or 10 mg Livdelzi vs placebo), and the ongoing open label study in people with PBC and hepatic impairment..

传统研究包括开放标签的2期剂量范围研究（2毫克、5毫克或10毫克Livdelzi）、开放标签的3/4期长期安全性研究（5毫克或10毫克Livdelzi）、3期安慰剂对照的ENHANCE研究（5毫克或10毫克Livdelzi对比安慰剂），以及正在进行的针对PBC和肝功能损害患者的开放标签研究。

About RESPONSE (NCT04620733)

关于RESPONSE（NCT04620733）

RESPONSE was a pivotal Phase 3, double-blind, placebo-controlled clinical trial designed to evaluate the efficacy and safety of Livdelzi in adults with primary biliary cholangitis (PBC) who have shown inadequate response or intolerance to ursodeoxycholic acid (UDCA). The trial enrolled 193 participants across multiple sites worldwide.

RESPONSE 是一项关键的 III 期、双盲、安慰剂对照临床试验，旨在评估 Livdelzi 在对熊去氧胆酸 (UDCA) 反应不足或不耐受的原发性胆汁性胆管炎 (PBC) 成人患者中的疗效和安全性。该试验在全球多个地点招募了 193 名参与者。

RESPONSE assessed the key biomarker of cholestasis alkaline phosphatase (ALP) and other parameters of liver function, as well as secondary endpoints including pruritus and other patient quality of life measurements..

RESPONSE 评估了胆汁淤积的关键生物标志物碱性磷酸酶 (ALP) 和其他肝功能参数，以及包括瘙痒和其他患者生活质量指标在内的次要终点。

Participants in the RESPONSE trial received a daily oral dose of 10 mg of Livdelzi for 12 months. The trial aimed to address the high unmet need for effective second-line therapies for individuals with PBC. The approvals of Livdelzi were based primarily on data from the RESPONSE study.

RESPONSE 试验的参与者连续 12 个月每天口服 10 毫克 Livdelzi。该试验旨在解决 PBC 患者对有效二线治疗方案的高度未满足需求。Livdelzi 的获批主要基于 RESPONSE 研究的数据。

About ENHANCE (NCT03602560

关于ENHANCE（NCT03602560

ENHANCE was a Phase 3, multicenter, randomized, double-blind, placebo-controlled study designed to evaluate the safety and efficacy of seladelpar in participants with primary biliary cholangitis (PBC) and an inadequate response or intolerance to UDCA. The trial investigated the potential of seladelpar to improve biochemical markers of liver function and reduce pruritus, and assessed safety.

ENHANCE 是一项 III 期、多中心、随机、双盲、安慰剂对照研究，旨在评估 seladelpar 在对 UDCA 反应不足或不耐受的原发性胆汁性胆管炎 (PBC) 参与者中的安全性和有效性。该试验研究了 seladelpar 改善肝功能生化标志物和减轻瘙痒的潜力，并评估了其安全性。

The ENHANCE study was terminated early due to reasons determined to be unrelated to Livdelzi..

由于被认为与Livdelzi无关的原因，ENHANCE研究被提前终止。

About PBC

关于PBC

PBC is a chronic, autoimmune disease of the bile ducts that affects approximately 130,000 Americans. PBC is more common in women and causes liver damage that can progress to liver failure and result in the need for liver transplant, if left untreated. The most common symptoms of PBC are pruritus (chronic itch) and fatigue, which up to 80% of people with PBC can experience and can profoundly compromise quality of life.

原发性胆汁性胆管炎（PBC）是一种慢性自身免疫性疾病，影响胆管，约有13万美国人受其影响。PBC在女性中更为常见，会导致肝损伤，如果不治疗，可能会发展为肝衰竭并需要进行肝移植。PBC最常见的症状是瘙痒（慢性瘙痒）和疲劳，高达80%的PBC患者可能会经历这些症状，严重影响生活质量。

Symptoms of PBC are often invisible to others and the journey to a PBC diagnosis can be long and challenging. There is currently no cure for PBC, and treatment goals include slowing disease progression and reducing the symptoms related to cholestasis (impaired bile flow), such as cholestatic itch. The effect is primarily measured by an improvement in liver biochemical tests, including the normalization of alkaline phosphatase (ALP) levels, an important marker of disease progression in PBC..

原发性胆汁性胆管炎 (PBC) 的症状对他人来说往往是隐形的，而确诊 PBC 的过程可能会漫长且充满挑战。目前，PBC 尚无治愈方法，治疗目标包括减缓疾病进展以及减轻与胆汁淤积（胆汁流动受阻）相关的症状，例如胆汁淤积性瘙痒。其效果主要通过肝生化指标的改善来衡量，包括碱性磷酸酶 (ALP) 水平的正常化，这是衡量 PBC 疾病进展的重要标志物。

About Livdelzi

关于Livdelzi

Livdelzi is an oral PPAR-delta agonist, or delpar, for the treatment of PBC. PPAR-delta has been shown to regulate critical metabolic and liver disease pathways. Preclinical and clinical data indicate Livdelzi has anticholestatic, anti-inflammatory, antipruritic, and antifibrotic effects.

Livdelzi 是一种口服的PPAR-delta激动剂，或称delpar，用于治疗PBC。PPAR-delta已被证明能够调节关键的代谢和肝脏疾病通路。临床前和临床数据表明，Livdelzi具有抗胆汁淤积、抗炎、止痒和抗纤维化的效果。

Livdelzi has potential to help meet the current unmet need of people living with PBC, as the first and only treatment that achieved statistically significant improvements across biochemical response, ALP normalization, and pruritus versus placebo. Pruritus is a common symptom that can significantly impair quality of life in people with PBC..

Livdelzi 有潜力帮助满足目前原发性胆汁性胆管炎（PBC）患者未被满足的需求，作为首个也是唯一一个在生化反应、ALP正常化和与安慰剂相比的瘙痒方面取得统计学显著改善的治疗药物。瘙痒是 PBC 患者中常见的症状，可能会显著影响生活质量。

U.S. Indication for Livdelzi

美国Livdelzi适应症

Livdelzi is indicated for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults who have had an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA.

Livdelzi 适用于治疗成人原发性胆汁性胆管炎 (PBC)，与熊去氧胆酸 (UDCA) 联合用于对 UDCA 反应不足的患者，或作为无法耐受 UDCA 的患者的单药治疗。

This indication is approved under accelerated approval based on a reduction of ALP. Improvement in survival or prevention of liver decompensation events have not been demonstrated. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s)..

该适应症是基于ALP降低而获得加速批准的。尚未证明其在生存率提高或预防肝脏失代偿事件方面的效果。该适应症的持续批准可能取决于在确证性试验中对临床益处的验证和描述。

Limitations of Use:

使用限制：

Use of Livdelzi is not recommended in patients who have or develop decompensated cirrhosis (e.g., ascites, variceal bleeding, hepatic encephalopathy).

不建议失代偿性肝硬化（例如，腹水、静脉曲张出血、肝性脑病）患者使用Livdelzi。

About Gilead Sciences in Liver Disease

关于吉利德科学在肝病领域

For decades, Gilead has pioneered the way forward to improve the lives of people living with liver disease around the world. The company has helped to transform hepatitis C from a chronic condition into one that can be cured for millions of people. For individuals living with hepatitis B or D, Gilead's focus on advancing medicines drives hope that today’s research will turn into tomorrow’s cures.

几十年来，吉利德一直致力于改善全球肝病患者的生活。该公司帮助将丙型肝炎从一种慢性疾病转变为可以为数百万人治愈的疾病。对于乙型或丁型肝炎患者，吉利德专注于推进药物研发，为今天的科研能够转化为明天的治愈方案带来了希望。

Beyond viral hepatitis, Gilead is working to deliver advanced treatments for people living with PBC. The commitment of Gilead doesn’t stop there. Through ground-breaking science and collaborative partnerships, the company strives to create healthier futures for everyone living with liver disease. Gilead remains devoted to a future without liver disease..

除了病毒性肝炎，吉利德还致力于为原发性胆汁性胆管炎（PBC）患者提供先进的治疗方案。吉利德的承诺不止于此。通过开创性的科学和协作伙伴关系，公司努力为所有肝病患者创造更健康的未来。吉利德始终致力于实现一个没有肝病的未来。

About Gilead Sciences

关于吉利德科学公司

Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, COVID-19, cancer and inflammation.

吉利德科学公司是一家生物制药公司，三十多年来一直致力于医学领域的突破，旨在为全人类创造一个更加健康的世界。公司致力于推动创新药物的研发，以预防和治疗危及生命的疾病，包括艾滋病、病毒性肝炎、新冠肺炎、癌症和炎症等。

Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California..

吉利德在全球35多个国家开展业务，总部位于加利福尼亚州的福斯特城。