PRINCETON, N.J.--(BUSINESS WIRE)--Bristol Myers Squibb (NYSE: BMY) today announced an update following the initial analysis of results from the first of two induction studies in the Phase 3 YELLOWSTONE clinical trial program evaluating Zeposia (ozanimod) in adult patients with moderate to severe active Crohn’s disease.

普林斯顿，新泽西州--（商业新闻短讯）--百时美施贵宝（纽约证券交易所：BMY）今天宣布了一项最新消息，此前对黄石公园第三期临床试验计划中两项诱导研究的第一项结果进行了初步分析，评估了中重度活动性克罗恩病成年患者的玉米赤霉病（ozanimod）。

The study did not meet its primary endpoint of clinical remission at Week 12.

该研究在第12周未达到临床缓解的主要终点。

The safety profile of Zeposia in this study was consistent with that observed in previously reported trials. The company will complete a full evaluation of the YELLOWSTONE trial data and work with investigators to share the results with the scientific community in the future.

本研究中玉米赤霉素的安全性与先前报道的试验中观察到的一致。该公司将完成对黄石公园试验数据的全面评估，并与调查人员合作，在未来与科学界分享结果。

“To date, no S1P modulator has shown an effect in a Phase 3 trial in Crohn’s disease, where a high unmet medical need remains for new therapies that offer more patients relief from symptoms and the potential for remission,” said Roland Chen, MD, senior vice president and head, Immunology, Cardiovascular and Neuroscience development, Bristol Myers Squibb.

Bristol-Myers Squibb高级副总裁兼免疫学、心血管和神经科学发展负责人Roland Chen医学博士说：“迄今为止，没有S1P调节剂在克罗恩病的3期试验中显示出效果，在该试验中，尚未满足的医疗需求仍然很高，需要新的疗法来缓解更多患者的症状和缓解潜力。”

“While we are disappointed that the primary endpoint was not reached in this first induction trial, we are committed to driving transformative science on behalf of individuals with immune-mediated diseases and would like to thank the investigators and patients who are participating in the YELLOWSTONE clinical trial program.”.

“虽然我们对第一次诱导试验未达到主要终点感到失望，但我们致力于代表免疫介导疾病患者推动变革性科学，并感谢参与黄石临床试验计划的研究人员和患者。”

About the YELLOWSTONE Clinical Trial Program

关于黄石公园临床试验计划

YELLOWSTONE is a Phase 3, multicenter clinical trial program consisting of two 12-week induction studies, a 52-week maintenance study and a 264-week open-label extension study. YELLOWSTONE is designed to evaluate the safety and efficacy of Zeposia (ozanimod) administered orally to patients with Crohn’s disease versus placebo.

黄石公园是一个3期多中心临床试验项目，包括两项为期12周的诱导研究，一项为期52周的维持研究和一项为期264周的开放标签扩展研究。黄石公园旨在评估克罗恩病患者口服Zeposia（ozanimod）与安慰剂的安全性和有效性。

The induction studies include approximately 600 patients each, with responders moving on to participate in the maintenance study. Nonresponders, those with disease relapse during maintenance, and completers of the maintenance study have the option to enroll in the open-label extension trial. Patients in the trial program are receiving Zeposia 0.92 mg (equivalent to 1 mg).

诱导研究包括大约600名患者，应答者继续参与维持研究。无应答者，维持期间疾病复发者和维持研究完成者可以选择参加开放标签延长试验。试验计划中的患者正在接受Zeposia 0.92毫克（相当于1毫克）。

The primary endpoint of the induction studies is the proportion of patients with a Crohn’s Disease Activity Index (CDAI) score of less than 150. The co-primary endpoints of the maintenance study are the proportion of patients with a CDAI score of less than 150 and the proportion of patients with a Simple Endoscopic Score for Crohn’s disease (SES-CD) score decrease from baseline of at least 50%.

诱导研究的主要终点是克罗恩病活动指数（CDAI）评分低于150的患者比例。维持研究的共同主要终点是CDAI评分低于150的患者比例，以及克罗恩病简单内镜评分（SES-CD）评分比基线降低至少50%的患者比例。

About Crohn’s disease

关于克罗恩病

Crohn's disease is a chronic inflammatory bowel disease (IBD) affecting the digestive tract. IBD results in the swelling or inflammation of the intestines, which may result in permanent damage and impact everyday life during disease flares. It is estimated that approximately 12.6 million people worldwide have IBD..

克罗恩病是一种影响消化道的慢性炎症性肠病（IBD）。IBD导致肠道肿胀或发炎，这可能导致永久性损伤，并在疾病发作期间影响日常生活。据估计，全世界约有1260万人患有IBD。。

For many patients, Crohn’s disease occurs in the colon or the third segment of the small intestine, the ileum, but may occur in any part of the intestinal tract. Signs and symptoms of Crohn’s disease can range from mild to severe. Most often, symptoms appear gradually but can sometimes develop suddenly or without warning.

对于许多患者来说，克罗恩病发生在结肠或小肠的第三段回肠，但可能发生在肠道的任何部位。克罗恩病的体征和症状可以从轻微到严重。大多数情况下，症状逐渐出现，但有时可能突然出现或没有警告。

Patients with Crohn’s disease may experience ongoing disease symptoms, or have episodes of symptom-free remission, which can be followed by relapse or flares. Patients with Crohn's disease are also at an increased risk of developing colorectal cancer. Living with Crohn’s disease may severely affect quality of life both physically and psychologically, particularly during disease flares and relapses.

克罗恩病患者可能会出现持续的疾病症状，或出现无症状缓解的发作，随后可能会复发或发作。克罗恩病患者患结直肠癌的风险也增加。患有克罗恩病可能会严重影响身体和心理上的生活质量，特别是在疾病发作和复发期间。

Bristol Myers Squibb: Pioneering Paths Forward in Immunology to Transform Patients’ Lives

百时美施贵宝：免疫学领域的先驱之路，以改变患者的生活

Bristol Myers Squibb is inspired by a single vision – transforming patients’ lives through science. For people living with immune-mediated diseases, the debilitating reality of enduring chronic symptoms and disease progression can take a toll on their physical, emotional and social well-being, making simple tasks and daily life a challenge.

百时美施贵宝的灵感来自一个单一的愿景——通过科学改变患者的生活。对于患有免疫介导疾病的人来说，忍受慢性症状和疾病进展的衰弱现实可能会损害他们的身体，情绪和社会福祉，使简单的任务和日常生活成为挑战。

Driven by our deep understanding of the immune system that spans over 20 years of experience, and our passion to help patients, the company continues to pursue pathbreaking science with the goal of delivering meaningful solutions that address unmet needs in rheumatology, gastroenterology, dermatology and pulmonology.

由于我们对免疫系统有着20多年的深入了解，以及我们对帮助患者的热情，该公司继续追求开创性的科学，目标是提供有意义的解决方案，以满足风湿病，胃肠病，皮肤病和肺病的未满足需求。

We follow the science, aiming to tailor therapies to individual needs, improve outcomes and expand treatment options by working to identify mechanisms with the potential to achieve long-term remission – and perhaps even cures – in the future. By building partnerships with researchers, patients and caregivers to deliver innovative treatments, Bristol Myers Squibb strives to elevate patient care to new standards and deliver what matters most – the promise of living a better life.

我们遵循这项科学，旨在通过努力确定有可能在未来实现长期缓解甚至治愈的机制，根据个人需求量身定制疗法，改善结果并扩大治疗选择。通过与研究人员、患者和护理人员建立合作伙伴关系，提供创新的治疗方法，百时美施贵宝致力于将患者护理提高到新的标准，并提供最重要的东西——生活得更好的承诺。

About Zeposia (ozanimod)

关于Zeposia（ozanimod）

Zeposia (ozanimod) is an oral, sphingosine 1-phosphate (S1P) receptor modulator that binds with high affinity to S1P receptors 1 and 5. Zeposia blocks the capacity of lymphocytes to egress from lymph nodes, reducing the number of lymphocytes in peripheral blood. The mechanism by which Zeposia exerts therapeutic effects in Crohn’s disease is unknown but may involve the reduction of lymphocyte migration into the gut.

Zeposia（ozanimod）是一种口服鞘氨醇1-磷酸（S1P）受体调节剂，与S1P受体1和5具有高亲和力。玉米醇溶酶阻断淋巴细胞从淋巴结流出的能力，减少外周血中淋巴细胞的数量。玉米醇溶酶在克罗恩病中发挥治疗作用的机制尚不清楚，但可能涉及减少淋巴细胞向肠道的迁移。

Zeposia is approved in numerous countries around the world for the treatment of adults with relapsing forms of MS and adults with moderately to severely active ulcerative colitis.

Zeposia在世界许多国家被批准用于治疗复发型MS的成年人和中度至重度活动性溃疡性结肠炎的成年人。

About Bristol Myers Squibb

关于百时美施贵宝

Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol Myers Squibb, visit us at BMS.com or follow us on LinkedIn, Twitter, YouTube, Facebook and Instagram..

百时美施贵宝是一家全球生物制药公司，其使命是发现、开发和提供创新药物，帮助患者战胜严重疾病。有关百时美施贵宝的更多信息，请访问BMS.com或在LinkedIn、Twitter、YouTube、Facebook和Instagram上关注我们。。