PARSIPPANY, N.J.--(BUSINESS WIRE)--Ferring Pharmaceuticals and its clinical development partner, Seikagaku Corporation (Seikagaku), today announced the presentation of data from two Phase 3 trials evaluating the efficacy and safety of SI-6603 (generic name: condoliase), an investigational product being studied for the treatment of radicular leg pain associated with lumbar disc herniation (LDH).

新泽西州帕西帕尼（商业新闻短讯）--费林制药公司及其临床开发合作伙伴Seikagaku Corporation（Seikagaku）今天宣布，将提供两项评估SI-6603（通用名：condoliase）疗效和安全性的3期临床试验数据，这是一种正在研究用于治疗腰椎间盘突出症（LDH）相关的根性腿痛的研究产品。

The podium presentation at the North American Spine Society’s (NASS) Annual Meeting included results from one study conducted in the U.S. and one in Japan. In addition, The Spine Journal has published the results of the pivotal U.S. Phase 3 study..

在北美脊柱学会（NASS）年会的讲台上，一项研究在美国进行，另一项在日本进行。此外，《脊柱杂志》还发表了美国关键的3期研究结果。。

NASS Presentation

NASS演示

In the double-blind, sham or placebo controlled Phase 3 studies, patients with LDH were randomized to receive either a single intradiscal injection of SI-6603 1.25 Units or control (sham injection for U.S. study; placebo injection for Japanese study) followed by 52 weeks of observation. The modified intention-to-treat population in the U.S.

在双盲，假手术或安慰剂对照的3期研究中，LDH患者被随机分配接受单次椎间盘内注射SI-6603 1.25单位或对照（美国研究为假注射；日本研究为安慰剂注射），然后观察52周。美国修改后的意向治疗人群。

study included 341 participants (SI-6603 n=169; sham n=172), and the study population in Japan included 163 participants (SI-6603 n=82; placebo n=81). The studies met their primary endpoint, showing significantly greater change from baseline (CFB) in worst leg pain at Week 13 compared to sham (U.S.) / placebo (Japan) (least squares mean [LSM] difference: -7.5 [p=0.0263] for the U.S.

研究包括341名参与者（SI-6603 n=169；sham n=172），日本的研究人群包括163名参与者（SI-6603 n=82；安慰剂n=81）。这些研究达到了他们的主要终点，显示与假手术组（美国）/安慰剂组（日本）相比，第13周最严重腿痛的基线（CFB）变化显着更大（最小二乘平均值[LSM]差异：-美国为7.5[p=0.0263]。

study and -15.2 [p=0.001] for the Japan study)..

日本研究为-15.2（p=0.001）。。

“Treatment for radicular leg pain associated with lumbar disc herniation is currently limited to conservative pain management and physical therapy or surgery. The data from these two Phase 3 studies further support the potential of SI-6603 as a therapeutic option for the millions of Americans suffering from the debilitating impact of this condition,” said Kee Kim, MD, University of California, Davis..

加州大学戴维斯分校医学博士Kee Kim说：“与腰椎间盘突出症相关的根性腿痛的治疗目前仅限于保守的疼痛管理和物理治疗或手术。这两项3期研究的数据进一步支持了SI-6603作为数百万患有这种疾病的衰弱影响的美国人的治疗选择的潜力。”。。

The most common treatment-emergent adverse events (TEAEs) in the U.S. trial were spinal magnetic resonance imaging abnormalities (SI-6603 28.1%; sham 9.2%) and back pain (SI-6603 19.2%; sham 12.6%). In the Japan trial, the most common TEAEs were back pain (SI-6603 36.6%; placebo 33.3%) and leg pain (SI-6603 25.6%; placebo 35.8%).

美国试验中最常见的治疗紧急不良事件（TEAE）是脊柱磁共振成像异常（SI-6603 28.1%；假手术9.2%）和背痛（SI-6603 19.2%；假手术12.6%）。在日本试验中，最常见的TEAE是背痛（SI-6603 36.6%；安慰剂33.3%）和腿痛（SI-6603 25.6%；安慰剂35.8%）。

There were no treatment-related serious adverse events (SAEs) with SI-6603 in the U.S. study, and in the Japan study, one SAE (back pain) was considered potentially related to SI-6603..

在美国的研究中，SI-6603没有治疗相关的严重不良事件（SAE），在日本的研究中，一种SAE（背痛）被认为可能与SI-6603有关。。

About the Phase 3 Trial in the U.S.

关于美国的第三阶段试验。

In this randomized double-blind, sham-controlled, parallel Phase 3 study — known as the Discovery 6603 clinical trial (NCT03607838) — participants were randomized 1:1 to receive either SI-6603 (1.25 U) or sham injection followed by 52 weeks of observation. The primary endpoint was defined as the CFB to Week 13 in worst leg pain during the past 24 hours averaged over the previous seven days, as assessed by Visual Analogue Scale, a pain rating score from 0 – 100 with a higher score indicating greater pain intensity.

在这项随机双盲，假对照，平行3期研究（称为Discovery 6603临床试验（NCT03607838））中，参与者以1:1的比例随机接受SI-6603（1.25 U）或假注射，然后进行52周的观察。主要终点定义为过去7天平均24小时内最严重腿痛的CFB至第13周，通过视觉模拟评分进行评估，疼痛评分为0-100，评分越高表示疼痛强度越大。

Key secondary endpoints included the CFB in average worst leg pain at 52 weeks, percentage of participants with negative straight leg raise test, and 50% responder rates for worst leg pain and Oswestry Disability Index (ODI). Since the key secondary endpoint of change in average worst leg pain at Week 52 was not significant, the serial gatekeeping testing algorithm dictated that there were no significant group differences for Week 13 herniation volume or ODI score regardless of their p-values.

关键的次要终点包括52周时平均最严重腿痛的CFB，直腿抬高试验阴性的参与者百分比，以及最严重腿痛和Oswestry残疾指数（ODI）的50%应答率。由于第52周平均最严重腿痛变化的关键次要终点不显着，因此连续守门测试算法表明，无论其p值如何，第13周疝体积或ODI评分均无显着组间差异。

Endpoints were assessed using a mixed model for repeated measures (MMRM) analysis of the modified intention-to-treat population (mITT)..

使用改良意向治疗人群（mITT）的重复测量混合模型（MMRM）分析评估终点。。

The trial included U.S. participants ages 30 to 70 years old who had contained posterolateral LDH with the chief complaint being unilateral radiculopathy/radicular leg pain and inadequate improvement in pain despite more than six weeks of conservative treatment. Among 352 randomized participants, 341 constituted the mITT population (SI-6603 n=169; sham injections n=172)..

该试验包括年龄在30至70岁之间的美国参与者，他们患有后外侧LDH，主要症状是单侧神经根病/神经根性腿痛，尽管保守治疗超过六周，但疼痛改善不足。在352名随机参与者中，341人构成了mITT人群（SI-6603 n=169；假注射n=172）。。

About the Phase 3 Trial in Japan

关于日本的第三阶段试验

In this randomized, double-blind, placebo-controlled study, participants were randomized 1:1 to receive either a single injection of SI-6603 (1.25U) or placebo injection, followed by 52 weeks of observation. The primary endpoint was the CFB to Week 13 in average worst leg pain during the past 24 hours over the previous seven days, as assessed by Visual Analogue Scale, a pain rating score from 0 – 100 with a higher score indicating greater pain intensity.

在这项随机，双盲，安慰剂对照研究中，参与者以1:1的比例随机接受单次注射SI-6603（1.25U）或安慰剂注射，然后进行52周的观察。主要终点是CFB至第13周在过去7天的过去24小时内平均最严重的腿部疼痛，通过视觉模拟评分进行评估，疼痛评分为0-100，评分越高表示疼痛强度越大。

Secondary endpoints included CFB up to Week 52 in average worst leg pain, herniation volume and ODI score. Endpoints were assessed using an analysis of covariance model..

次要终点包括CFB至第52周的平均最严重腿痛，疝气量和ODI评分。使用协方差分析模型评估终点。。

About Lumbar Disc Herniation

关于腰椎间盘突出症

About 9 million adults in the U.S. suffer from lumbar disc herniation each year. A disc herniation is a displacement of the gel-like inner core of the intervertebral disc, called the nucleus pulposus, through its external membrane (annulus fibrosus) due to wear and tear, aging or sudden injury. As a result of this displacement, the disc presses on the spinal nerve, often producing pain.1,2.

美国每年约有900万成年人患有腰椎间盘突出症。椎间盘突出症是由于磨损，衰老或突然受伤，椎间盘的凝胶状内核（称为髓核）通过其外膜（纤维环）移位。由于这种移位，椎间盘压迫脊神经，通常会产生疼痛。

About SI-6603

关于SI-6603

SI-6603, which contains condoliase as its active pharmaceutical ingredient, is an investigational product being studied for the treatment of radicular leg pain associated with lumbar disc herniation via a single, direct intradiscal injection. SI-6603 (condoliase) is designed to reduce nerve root compression and thereby the radicular leg pain..

SI-6603含有condoliase作为其活性药物成分，是一种正在研究的研究产品，用于通过单次直接椎间盘注射治疗与腰椎间盘突出症相关的根性腿痛。SI-6603（condoliase）旨在减少神经根压迫，从而减少腿部神经根疼痛。。

SI-6603 was developed by Seikagaku. Marketing approval for SI-6603 in Japan was obtained from the Japanese Ministry of Health, Labour and Welfare in March 2018 and SI-6603 has been marketed in Japan only as HERNICORE® 1.25 units for intradiscal injection through Seikagaku's Japanese sales partner Kaken Pharmaceutical Co., Ltd.

SI-6603由Seikagaku开发。SI-6603在日本的上市许可于2018年3月获得日本厚生劳动省的批准，SI-6603仅通过Seikagaku的日本销售合作伙伴Kaken Pharmaceutical Co.，Ltd在日本销售为HERNICORE®1.25单位，用于椎间盘内注射。

(Tokyo, Japan) since August 1, 2018.3.

（日本东京）自2018年8月1日起。

Alliance with Seikagaku

与Seikagaku结盟

Seikagaku and Ferring entered into a license agreement for SI-6603 in August 2016. Ferring plans to commercialize the product in the United States upon FDA approval and has received further rights to develop, register and commercialize SI-6603 worldwide, excluding Japan.

Seikagaku和Ferring于2016年8月签订了SI-6603许可协议。Ferring计划在FDA批准后在美国将该产品商业化，并获得了在除日本以外的全球范围内开发，注册和商业化SI-6603的进一步权利。

About Ferring Pharmaceuticals

关于Ferring Pharmaceuticals

Ferring Pharmaceuticals is a privately-owned, research-driven, specialty biopharmaceutical group committed to building families and helping people live better lives. In the United States, Ferring is a leader in reproductive medicine and maternal health, and in areas of gastroenterology and orthopaedics.

Ferring Pharmaceuticals是一家私营、以研究为导向的专业生物制药集团，致力于建立家庭，帮助人们过上更好的生活。在美国，费林是生殖医学和孕产妇健康以及胃肠病学和骨科领域的领导者。

We are at the forefront of innovation in microbiome-based therapeutics and uro-oncology intravesical gene therapy. Our company was founded in 1950 and is headquartered in Saint-Prex, Switzerland. Ferring employs more than 7,000 people worldwide and markets its medicines in over 100 countries. Ferring USA is based in Parsippany, New Jersey, and employs more than 900 employees..

。我们公司成立于1950年，总部位于瑞士圣普雷克斯。Ferring在全球拥有7000多名员工，其药品在100多个国家销售。Ferring USA总部位于新泽西州帕西帕尼，拥有900多名员工。。