Cara Therapeutics Completes Full Enrollment in KARE Phase 2 Trial of Oral KORSUVA™ in Atopic Dermatitis Patients with Moderate-to-Severe Pruritus

Cara Therapeutics完成KARE 2期口服Korsuva™治疗伴有中度至重度瘙痒的特应性皮炎患者试验的全部注册

2020-12-03 01:33:20 BioSpace

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- Topline data expected in first half of 2021- STAMFORD, Conn., Dec. 02, 2020 (GLOBE NEWSWIRE) -- Cara Therapeutics, Inc.. (Nasdaq: CARA), a biopharmaceutical company focused on developing and commercializing new chemical entities designed to alleviate pruritus by selectively targeting peripheral kappa opioid receptors, or KORs, today announced that it has completed full enrollment of its KARE Phase 2 dose-ranging clinical trial of Oral KORSUVA™ (difelikefalin tablets) for the treatment of moderate-to-severe pruritus in atopic dermatitis patients. The trial has enrolled 400 patients at multiple clinical sites across the United States (US). “Full enrollment of the KARE Phase 2 trial on schedule represents an important milestone for the clinical development of Oral KORSUVA. We look forward to reporting topline data from this trial in early 2021,” said Derek Chalmers, Ph.D., D.Sc., President and Chief Executive Officer of Cara Therapeutics. “Pruritus treatment continues to be a significant unmet need for patients with atopic dermatitis and we believe Oral KORSUVA has the potential to be a first-in-class oral anti-pruritic product with a favorable safety profile.” KARE Phase 2 Trial Design The KARE Phase 2 trial is a randomized, double-blind, placebo-controlled study that is designed to evaluate the efficacy and safety of Oral KORSUVA for moderate-to-severe pruritus in approximately 400 adult subjects with atopic dermatitis. Subjects were randomized to three tablet strengths of Oral KORSUVA: 0.25 mg, 0.5 mg and 1 mg taken twice daily (BID) versus placebo for 12 weeks followed by 4 weeks of an active extension phase. KARE’s primary efficacy endpoint is change from baseline in the weekly mean of the daily 24-hour Itch NRS score at week 12 of the treatment period. The key secondary endpoint for KARE is the assessment of the proportion of patients achieving an improvement from baseline of ≥4 points with respect to the weekly mean of the daily 24-hour Itch NRS score at week 12. Itch-related quality of life scores at the end of week 12 are assessed by the total Skindex-10 and 5-D itch scales. A prespecified interim conditional power assessment, conducted after approximately 50% of the originally targeted patient number completed the designated 12-week treatment period, was completed in the second quarter of this year. Based on the Independent Data Monitoring Committee’s (IDMC) recommendation, the size of the KARE trial was increased by approximately 28%, from an original enrollment target of 320 patients to approximately 400 patients, to maintain the prespecified statistical power of 80 percent or greater on the trial’s primary and key secondary endpoints of change from baseline in the weekly mean of the daily 24-hour Itch Numeric Rating Scale (Itch NRS) and proportion of patients achieving a >4 point improvement in Itch NRS score at week 12, respectively. About Cara Therapeutics Cara Therapeutics is a clinical-stage biopharmaceutical company focused on developing and commercializing new chemical entities designed to alleviate pruritus by selectively targeting peripheral kappa opioid receptors, or KORs. Cara is developing a novel and proprietary class of product candidates, led by KORSUVA™ (CR845/difelikefalin), a first-in-class KOR agonist that targets the body’s peripheral nervous system, as well as certain immune cells. In two Phase 3 trials, KORSUVA Injection has demonstrated statistically significant reductions in itch intensity and concomitant improvement in quality of life measures in hemodialysis patients with moderate-to-severe chronic kidney disease-associated pruritus (CKD-aP). Oral KORSUVA has successfully completed a Phase 2 trial for the treatment of pruritus in patients with CKD and is currently in Phase 2 trials in atopic dermatitis and primary biliary cholangitis patients with moderate-to-severe pruritus. The FDA has conditionally accepted KORSUVA™ as the trade name for difelikefalin injection. CR845/difelikefalin is an investigational drug product and its safety and efficacy have not been fully evaluated by any regulatory authority. Forward-looking Statements Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Examples of these forward-looking statements include statements concerning the ongoing trials, including the timing for reporting topline data, future development of Oral KORSUVA for pruritus in patients with atopic dermatitis and the potential for Oral KORSUVA to be a first-in-class anti-pruritic product with a favorable safety profile for these patients. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Risks are described more fully in Cara's filings with the Securities and Exchange Commission, including the "Risk Factors" section of Cara's Quarterly Report on Form 10-Q for the quarter ended September 30, 2020 and its other documents subsequently filed with or furnished to the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. Except to the extent required by law, Cara undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made. MEDIA CONTACT: Annie Starr 6 Degrees 973-415-8838 astarr@6degreespr.com INVESTOR CONTACT: Janhavi Mohite Stern Investor Relations, Inc. janhavi.mohite@SternIR.com
-预计2021年上半年的背线数据- 康涅狄格州斯坦福德,2020年12月2日(环球新闻通讯社)--卡拉治疗公司。(纳斯达克市场代码:CARA)是一家生物制药公司,专注于开发和商业化旨在通过选择性靶向外周卡帕阿片受体或KORs来减轻瘙痒的新型化学实体。该公司今天宣布,它已经完成了口服Korsuva™(地非利凯法林片)的KARE 2期剂量范围临床试验的全部注册,用于治疗特应性皮炎患者的中度至重度瘙痒。该试验在全美多个临床点招收了400名患者。 KARE 2期试验的如期全面注册代表了口服Korsuva临床发展的一个重要里程碑。我们期待着在2021年初报告这项试验的topline数据,“Cara Therapeutics公司总裁兼首席执行官Derek Chalmers博士说。瘙痒治疗仍然是特应性皮炎患者尚未满足的一个重要需求,我们相信口服KORSUVA有潜力成为一流的口服止痒产品,具有良好的安全性。“ KARE第2阶段试验设计 KARE 2期试验是一项随机,双盲,安慰剂对照研究,旨在评估口服KORSUVA治疗约400名患有特应性皮炎的成人受试者中至重度瘙痒的疗效和安全性。受试者随机分为三种剂量的口服Korsuva:0.25毫克,0.5毫克和1毫克,每日两次(BID),与安慰剂对照12周,随后是4周的活动延长期。 KARE的主要疗效终点是在治疗期的第12周,每日24小时瘙痒NRS评分的周均值与基线相比发生变化。KARE的关键次要终点是评估相对于第12周的每日24小时瘙痒NRS评分的周均值,从基线改善≥4分的患者比例。在第12周结束时,瘙痒相关的生活质量评分通过Skindex-10和5-D瘙痒量表进行评估。 在约50%的原目标病人完成指定的12周治疗期后,预先指定的中期条件能力评估已于今年第二季度完成。基于独立数据监测委员会(IDMC)的建议,KARE试验的规模增加了大约28%,从最初的320名患者的登记目标增加到大约400名患者,以保持试验的主要和关键次要终点在第12周每日24小时瘙痒数值评定量表(瘙痒NRS)的周均值和瘙痒NRS评分改善>4分的患者比例中分别比基线变化的80%或更高的预先指定的统计能力。 关于Cara Therapeutics Cara Therapeutics是一家临床阶段的生物制药公司,专注于开发和商业化新的化学实体,通过选择性地靶向外周卡帕阿片受体或KORs来减轻瘙痒。Cara公司正在开发一种新的专利候选产品,由Korsuva™公司(CR845/Difelikefalin)牵头,这是一种一流的KOR激动剂,靶向人体的周围神经系统以及某些免疫细胞。在两项3期试验中,KORSUVA注射液显示,在患有中度至重度慢性肾脏病相关瘙痒症(CKD-aP)的血液透析患者中,瘙痒强度有显著的降低,生活质量指标也随之提高。口服KORSUVA已成功完成治疗CKD患者瘙痒症的2期试验,目前正处于特应性皮炎和原发性胆汁性胆管炎中重度瘙痒患者的2期试验。 FDA已有条件地接受Korsuva™作为地非利凯法林注射液的商品名。CR845/difelikefalin是一种研究性药物产品,其安全性和有效性尚未得到任何监管机构的充分评估。 前瞻性陈述 本新闻稿中所包含的关于非历史事实的事项的陈述属于1995年《私人证券诉讼改革法案》含义内的“前瞻性陈述”。这些前瞻性陈述的例子包括关于正在进行的试验的陈述,包括报告背线数据的时间,口服KORSUVA治疗特应性皮炎患者瘙痒的未来发展,以及口服KORSUVA成为一流抗瘙痒产品的潜力,该产品对这些患者具有良好的安全性。由于此类陈述受到风险和不确定性的影响,实际结果可能与此类前瞻性陈述所表达或暗示的结果大不相同。风险在CARA提交给证券交易委员会的文件中有更全面的描述,包括CARA截至2020年9月30日的季度报告10-Q表格中的“风险因素”部分以及随后提交给证券交易委员会的其他文件。本新闻稿中包含的所有前瞻性陈述仅限于发表之日。除法律规定的情况外,Cara没有义务更新此类声明,以反映在声明发布之日后发生的事件或存在的情况。 媒体联系人: 安妮·斯塔尔 6度 973-415-8838 电子邮件:astarr@6degreespr.com 投资者联系方式: 扬哈维莫希特 斯特恩投资者关系公司。 电子邮件:janhavi.mohite@sternir.com

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