A Randomised, Double-Blind, Placebo-Controlled, Multicentre, Phase 3, Clinical Study of QLG2198 in Haemodialysis Adult Subjects With Moderate-to-Severe Pruritus

This a multicentre study that consists of a 12-week double-blind period, and a 14-week open-label extension period and a 1-week follow-up period.

开始日期2024-06-18

申办/合作机构

齐鲁制药有限公司

NCT05978063 / Terminated临床2/3期

A 2-part, Multicenter, Randomized, Double-blind Study to Evaluate the Efficacy and Safety of Oral Difelikefalin for Moderate-to-Severe Pruritus in Adult Subjects With Notalgia Paresthetica

This is a 2-part, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of twice-daily (BID) oral difelikefalin for moderate-to-severe pruritus in adult subjects with NP.

开始日期2023-08-01

申办/合作机构

CARA Therapeutics, Inc.

NCT05885763 / Completed临床1期

A Phase 1, Single-arm, Open-label Study to Evaluate the Pharmacokinetics and Safety of Intravenous Difelikefalin in Adult Chinese Subjects on Haemodialysis

This is a Phase 1, single-arm, open-label study to evaluate the safety, PK, and tolerability of a repeated (3 times weekly) dose of difelikefalin administered as IV bolus injections to adult Chinese HD subjects. Treatment period is one week and there is a safety follow-up period of 1 week.

开始日期2023-06-26

申办/合作机构

Vifor Fresenius Medical Care Renal Pharma Ltd.

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100 项与醋酸地非法林相关的临床结果

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100 项与醋酸地非法林相关的转化医学

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100 项与醋酸地非法林相关的专利（医药）

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项与醋酸地非法林相关的文献（医药）

2024-02-01·Nephrologie & therapeutique

Article

作者: Rostoker, Guy ; Florens, Nans ; Chauveau, Philippe ; Lanot, Antoine ; Testa, Angelo ; Bataille, Pierre ; Misery, Laurent ; Touzot, Maxime

Chronic kidney disease-associated pruritus (CKD-aP) is a disabling symptom which is frequent and often underestimated. Pa-MRC has a negative impact on quality of life, and is frequently accompanied by sleep disorders and depression. The approval of difelikefalin – a kappa opioid receptor agonist – in this indication requires updated recommendations. As a first step, secondary causes of pruritus without skin lesions must be ruled out, and general measures taken (emollients, psychological support, optimization of dialysis, normalization of serum calcium, phosphate and PTH in the range proposed by the KGIDO guidelines, treatment of iron deficiency). A therapeutic test with a non-sedating oral antihistamine may be proposed. If this test is negative, Pa-MRC must be strongly suspected, and its intensity (WI-NRS scale) and impact on quality of life assessed. In the case of mild Pa-MRC (WI-NRS ≤ 3), only general measures are implemented. If Pa-MRC is moderate to severe (WI-NRS ≥ 4), specific treatment with difelikefaline can be initiated for 6 months in addition to general measures. At 3 months, if the response is complete (WI-NRS score ≤ 1) or partial (decline ≥ 3 points), treatment is continued. At 6 months, if the response is complete, treatment may be discontinued with the patient’s agreement; treatment is maintained if the response is partial. At 3 or 6 months, if response is insufficient (decline < 3 points) and/or in the event of intolerance, treatment is discontinued and an alternative treatment (e.g., gabapentinoids, UVB) may be considered after dermatological consultation.

2024-04-01·Clinical nephrology

Efficacy and safety of difelikefalin in the treatment of hemodialysis patients with pruritus: A meta-analysis and systematic review

Review

作者: Yang, Yujie ; Fan, Dandan ; Liu, Jing ; Xue, Guifang ; Yuan, Huaihong ; Ma, Chunyan ; Liao, Ruoxi

BACKGROUND:

The incidence of pruritus associated with hemodialysis (HD) patients can be as high as 70%, and ~ 40% of patients suffer from moderate to severe systemic pruritus. Difelikefalin (CR845), a peripheral restrictor κ-opioid receptor agonist, activates opioid receptors on peripheral neurons and immune cells to relieve pruritus in patients. However, the clinical effect of difelikefalin on HD-related pruritus is unclear. Therefore, the purpose of this meta-analysis and systematic review was to investigate the safety and efficacy of difelikefalin in the treatment of HD-associated pruritus.

OBJECTIVE:

This study explored the efficacy and safety of difelikefalin in the treatment of pruritus in HD patients by systematic review and meta-analysis.

MATERIALS AND METHODS:

Randomized controlled trials on difelikefalin in the treatment of pruritus in HD patients were retrieved from PubMed, Embase, Cochrane Library, and Web of Science electronic databases. The retrieval deadline was January 1, 2023. Stata 15.0 software was used for data analysis of the included studies.

RESULTS:

A total of 4 randomized controlled trials were included, totaling 1,268 patients (736 patients in the experimental group and 532 patients in the control group). Results of the meta-analysis showed that, compared with the control group, difelikefalin could significantly improve the Worst Itch Numeric Rating Scale score (improvement > 3; risk ratio (RR) = 1.28, 95% confidence interval (CI) (1.07, 1.53)), decrease the 5-D itch score (standardized mean difference = -0.43, 95% CI (-0.55, -0.30)), and significantly improve adverse events (RR = 1.33, 95% CI (1.13, 1.56)).

CONCLUSION:

Although difelikefalin can improve itching symptoms in HD patients, it can also increase adverse reactions based on the current literature. Therefore, more studies are needed to further explore the safety and efficacy of difelikefalin treatment.

American journal of nephrology

Difelikefalin in Black/African American Hemodialysis Patients with Moderate-to-Severe Pruritus: Post hoc Analysis of KALM-1 and KALM-2

Article

作者: Wen, Warren ; Lerma, Edgar V ; Budden, Jeffrey ; Clegg, Deborah J ; Topf, Joel ; Menzaghi, Frédérique ; Morin, Isabelle ; Fishbane, Steven ; Rastogi, Anjay

Introduction: Black and African American (AA) people are over-represented in the kidney failure population; therefore, the safety and efficacy of difelikefalin in Black/AA patients was evaluated. Methods: This was a post hoc, pooled exploratory subgroup analysis of the Phase 3 KALM-1 and -2 studies. Patients undergoing hemodialysis (HD) who had moderate-to-severe chronic kidney disease-associated pruritus (CKD-aP) at enrollment were stratified into self-reported Black/AA or White subgroups. Patients were randomized (1:1) to receive intravenous (IV) difelikefalin 0.5 µg/kg or placebo for 12 weeks. Difelikefalin efficacy was assessed with validated patient-reported outcome questionnaires: 24-h Worst Itch Numerical Rating Scale (WI-NRS), 5-D itch, and Skindex‑10. Results: There were 249 (29.3%) patients from the KALM studies that self-identified as Black/AA (n = 135 difelikefalin; n = 114 placebo). Clinically meaningful (≥3-point) reduction in WI-NRS score was achieved by 47.9% of Black/AA patients with difelikefalin versus 24.6% with placebo (p < 0.001). More Black/AA patients achieved a ≥5-point 5-D itch total improvement (54.9% vs. 35.7%; p = 0.013) and a ≥15-point Skindex-10 score improvement with difelikefalin versus placebo (49.0% vs. 28.9%; p = 0.006) compared with White patients. Incidence of treatment-emergent adverse events (TEAEs) was higher for Black/AA patients (difelikefalin: 78.5%; placebo: 70.8%) versus White patients (difelikefalin: 64.8%; placebo: 61.8%). Conclusion: In this post hoc analysis, difelikefalin was efficacious in the Black/AA population and had an acceptable safety profile.

项与醋酸地非法林相关的新闻（医药）

2024-06-12

·BioSpace

Cara Therapeutics Announces Outcome of Part A of KOURAGE-1 Study Evaluating Oral Difelikefalin in Notalgia Paresthetica

– Oral difelikefalin did not demonstrate meaningful clinical benefit compared to placebo – – Company will discontinue clinical program in NP and explore strategic alternatives – STAMFORD, Conn., June 12, 2024 (GLOBE NEWSWIRE) -- Cara Therapeutics, Inc. (Nasdaq: CARA), a development-stage biopharmaceutical company leading a new treatment paradigm to improve the lives of patients suffering from pruritus, today announced the outcome from the dose-finding Part A of the KOURAGE-1 study evaluating the efficacy and safety of oral difelikefalin for moderate-to-severe pruritus in adult patients with notalgia paresthetica (NP). Oral difelikefalin did not demonstrate a meaningful clinical benefit at any dose compared to placebo, resulting in the Company’s decision to discontinue the clinical program in NP. “Given our strong proof-of-concept results in NP and the significant unmet need in this sensory neuropathy, we are disappointed that oral difelikefalin did not demonstrate a meaningful improvement in pruritus compared to placebo in the KOURAGE-1 Part A study,” said Christopher Posner, President and Chief Executive Officer of Cara Therapeutics. “We are grateful for the patients and investigators who participated in this study. We will be winding down the Phase 2/3 clinical program in NP and exploring strategic alternatives focused on maximizing shareholder value.” KOURAGE-1 Part A was a multicenter, randomized, double-blind, placebo-controlled study designed to inform the dose and sample size for the pivotal portions of the Phase 2/3 clinical program. In Part A, 214 patients were randomized to one of four arms: oral difelikefalin 2 mg twice a day (BID), 1 mg BID, 0.25 mg BID or placebo BID for 8 weeks. The primary endpoint was the proportion of patients achieving a ≥4-point improvement from baseline in the weekly mean of the daily 24-hour Itch-Numeric Rating Scale (I-NRS) score at Week 8. Oral difelikefalin did not demonstrate a meaningful clinical benefit at any dose compared to placebo. The drug was generally well tolerated with a safety pro to prior trials. As of March 31, 2024, the Company had approximately $70 million in cash, cash equivalents, and marketable securities. About Cara Therapeutics Cara Therapeutics is a development-stage biopharmaceutical company leading a new treatment paradigm to improve the lives of patients suffering from pruritus. The Company developed an IV formulation of difelikefalin, which is approved in the United States, EU, and multiple other countries for the treatment of moderate-to-severe pruritus associated with advanced chronic kidney disease in adults undergoing hemodialysis. The IV formulation is out-licensed worldwide. For more information, visit and follow the company on X (Twitter), LinkedIn and Instagram. 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 winding down of the Company’s Phase 2/3 clinical program in NP, the exploration of strategic alternatives and other statements that are not historical facts. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These risks are described more fully in Cara Therapeutics’ filings with the Securities and Exchange Commission, including the “Risk Factors” section of the Company’s Annual Report on Form 10-K for the year ending December 31, 2023 and its other documents subsequently filed with or furnished to the Securities and Exchange Commission, including its Form 10-Q for the quarter ended March 31, 2024. All forward-looking statements contained in this press release speak only as of the date on which they were made. Cara Therapeutics undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law. MEDIA CONTACT: Annie Spinetta 6 Degrees 973-768-2170 aspinetta@6degreespr.com INVESTOR CONTACT: Iris Francesconi, Ph.D. Cara Therapeutics 203-406-3700 investor@caratherapeutics.com

临床结果上市批准临床3期

2024-05-20

·信狐药迅

新药上市申请1个品规、仿制药上市申请5个品规发通知件；临床申请品种均默示许可| 新获批（5.13-5.19）

每周药品注册获批数据，分门别类呈现，一目了然。(5.13-5.19）小编收到有些用户反应，不想收到咱们每周文章的推送提醒，而有些用户又特别需要这个提醒，在小编强烈要求下，我们给力的程序员终于实现了可以关闭提醒的功能，这个绝对全网独一家喔，不想收到提醒的，只要在信狐药迅对话框内回复关键词“拒收文章提醒”，那么就可以不受推送的打扰啦!新药上市申请药品名称企业注册分类受理号SPH3127片上海上药信谊药厂有限公司1CXHS2300055艾司奥美拉唑镁碳酸氢钠胶囊厦门恩成制药有限公司2.2CXHS2200049国;CXHS2200049泽布替尼胶囊百济神州(苏州)生物科技有限公司2.4CXHS2300057盐酸安罗替尼胶囊正大天晴药业集团股份有限公司2.4CXHS2300010盐酸安罗替尼胶囊正大天晴药业集团股份有限公司2.4CXHS2300009盐酸安罗替尼胶囊正大天晴药业集团股份有限公司2.4CXHS2300008新药临床申请药品名称企业注册分类受理号CU-10101软膏科笛生物医药(无锡)有限公司1CXHL2400275CU-10101软膏科笛生物医药(无锡)有限公司1CXHL2400274CU-10101软膏科笛生物医药(无锡)有限公司1CXHL2400273CU-10101软膏科笛生物医药(无锡)有限公司1CXHL2400272SC0245片无锡智康弘义生物科技有限公司1CXHL2400248SC0245片无锡智康弘义生物科技有限公司1CXHL2400247BGB-24714胶囊百济神州(苏州)生物科技有限公司1CXHL2400239BGB-24714胶囊百济神州(苏州)生物科技有限公司1CXHL2400238BGB-24714胶囊百济神州(苏州)生物科技有限公司1CXHL2400237HRS-5346片山东盛迪医药有限公司1CXHL2400234HRS-5346片山东盛迪医药有限公司1CXHL2400233SHR0302碱凝胶江苏恒瑞医药股份有限公司1CXHL2400224SHR0302碱凝胶江苏恒瑞医药股份有限公司1CXHL2400223SR1375胶囊上海赛默罗生物科技有限公司1CXHL2400211SR1375胶囊上海赛默罗生物科技有限公司1CXHL2400210SR1375胶囊上海赛默罗生物科技有限公司1CXHL2400209RAG-17注射液中美瑞康核酸技术(南通)研究院有限公司1CXHL2400208SG1001片深圳市祥根生物有限公司1CXHL2400203吸入用XQ-001成都倍特新启生物医药有限责任公司1CXHL2400201苯磺酸氨氯地平颗粒杭州百诚医药科技股份有限公司2.2CXHL2400245苯磺酸氨氯地平颗粒杭州百诚医药科技股份有限公司2.2CXHL2400244BTP0209江苏诺和必拓新药研发有限公司2.2CXHL2400242BTP0209江苏诺和必拓新药研发有限公司2.2CXHL2400241BTP0209江苏诺和必拓新药研发有限公司2.2CXHL2400240阿戈美拉汀透皮贴剂鑫稳生物医药科技(嘉善)有限公司2.2CXHL2400225四价流感病毒裂解疫苗(MDCK细胞)成都新诺明生物科技有限公司2.2CXSL2400138注射用MK-2870默沙东研发(中国)有限公司1CXSL2400175SYS6002石药集团巨石生物制药有限公司1CXSL2400174重组抗PD-1全人源单抗注射液石药集团中奇制药技术(石家庄)有限公司1CXSL2400173SSGJ-707注射液沈阳三生制药有限责任公司1CXSL2400171注射用ILB-3101英诺湖医药(杭州)有限公司1CXSL2400169JMT202注射液上海津曼特生物科技有限公司1CXSL2400164注射用ZB001上海泽纳仕生物科技有限公司1CXSL2400133VVN1901滴眼液维眸生物科技(浙江)有限公司1CXSL2400123VVN1901滴眼液维眸生物科技(浙江)有限公司1CXSL2400122VVN1901滴眼液维眸生物科技(浙江)有限公司1CXSL2400121重组人绒促性素注射液苏州晟济药业有限公司3.3CXSL2400176仿制药申请药品名称企业注册分类受理号地高辛注射液安徽长江药业有限公司3CYHS2302574地高辛注射液安徽长江药业有限公司3CYHS2302573利伐沙班颗粒南京海纳制药有限公司3CYHS2302483头孢地尼干混悬剂广东金城金素制药有限公司3CYHS2301983注射用拉氧头孢钠山东蓝晶生物技术有限公司3CYHS2300800注射用拉氧头孢钠山东蓝晶生物技术有限公司3CYHS2300799盐酸去氧肾上腺素注射液成都瑞尔医药科技有限公司3CYHS2300675盐酸去氧肾上腺素注射液成都瑞尔医药科技有限公司3CYHS2300674帕拉米韦注射液国药集团容生制药有限公司3CYHS2300304帕拉米韦注射液国药集团容生制药有限公司3CYHS2300303帕拉米韦注射液石药集团中诺药业(石家庄)有限公司3CYHS2300186注射用尼可地尔天大药业(云南)有限公司3CYHS2202132国;CYHS2202132盐酸多巴酚丁胺注射液安徽茂康药业有限公司3CYHS2202060国;CYHS2202060奥美拉唑碳酸氢钠胶囊厦门恩成制药有限公司3CYHS2201919国;CYHS2201919注射用尼可地尔海口天行健药物研究有限公司3CYHS2201772国;CYHS2201772美索巴莫注射液浙江美迪深生物医药有限公司3CYHS2201665国;CYHS2201665盐酸利多卡因凝胶南京汉欣医药科技有限公司3CYHS2201594国;CYHS2201594地高辛注射液河北坤安药业有限公司3CYHS2201563国;CYHS2201563葡萄糖酸钙氯化钠注射液回音必集团抚州制药有限公司3CYHS2201498葡萄糖酸钙氯化钠注射液回音必集团抚州制药有限公司3CYHS2201497注射用盐酸罗沙替丁醋酸酯四川汇宇制药股份有限公司3CYHS2201160国;CYHS2201160马来酸氯苯那敏注射液南京泽恒医药技术开发有限公司3CYHS2101157国;CYHS2101157注射用头孢他啶阿维巴坦钠福安药业集团庆余堂制药有限公司4CYHS2201877注射用盐酸万古霉素海南普利制药股份有限公司4CYHS2200588国;CYHS2200588布立西坦片四川科伦药业股份有限公司3CYHL2400055布立西坦片四川科伦药业股份有限公司3CYHL2400054布立西坦片四川科伦药业股份有限公司3CYHL2400053醋酸地非法林注射液齐鲁制药(海南)有限公司3CYHL2400051艾氟洛芬贴剂湖南九典制药股份有限公司3CYHL2400047环孢素滴眼液(II)深圳欣祺医药科技有限公司3CYHL2400044琥珀酰明胶注射液山东齐都药业有限公司4CYHL2400046琥珀酰明胶电解质醋酸钠注射液山东齐都药业有限公司4CYHL2400045进口申请药品名称企业注册分类受理号瑞普替尼胶囊Bristol-Myers Squibb Company1JXHS2300056利多卡因凝胶贴膏Teikoku Pharma USA, Inc.5.1JXHS2200056国;JXHS2200056吸入用复方异丙托溴铵溶液M/s Cipla Ltd.5.2JYHS2300052ARV-471(PF-07850327)片Pfizer Inc.1JXHL2400052Lu AF28996 胶囊H. Lundbeck A/S1JXHL2400056Lu AF28996 胶囊H. Lundbeck A/S1JXHL2400055Lu AF28996 胶囊H. Lundbeck A/S1JXHL2400054Lu AF28996 胶囊H. Lundbeck A/S1JXHL2400053RO7435846片F. Hoffmann-La Roche Ltd.1JXHL2400051RO7435846片F. Hoffmann-La Roche Ltd.1JXHL2400050RO7435846片F. Hoffmann-La Roche Ltd.1JXHL2400049BAY 2965501口服溶液Bayer AG1JXHL2400044拉索昔芬片Sermonix Pharmaceuticals, Inc.2.4JXHL2400042AZD2936AstraZeneca AB1JXSL2400057Riliprubart注射液Sanofi-aventis Recherche & Developpement1JXSL2400052Riliprubart注射液Sanofi-aventis Recherche & Developpement1JXSL2400051LerodalcibepLIB Therapeutics, Inc.1JXSL2400049LerodalcibepLIB Therapeutics, Inc.1JXSL2400050中药相关申请药品名称企业注册分类受理号灵香片浙江佐力药业股份有限公司1.1CXZL2400010注：灰色字体部分结论为不批准或收到通知件；

申请上市临床申请

2024-05-13

·GlobeNewswire-Health Care

Cara Therapeutics Reports First Quarter 2024 Financial Results

Topline efficacy and safety results from KOURAGE 1 Part A portion of notalgia paresthetica (NP) pivotal program now expected by the end of 2Q24STAMFORD, Conn., May 13, 2024 (GLOBE NEWSWIRE) -- Cara Therapeutics, Inc. (Nasdaq: CARA), a development-stage biopharmaceutical company leading a new treatment paradigm to improve the lives of patients suffering from pruritus, today announced financial results and operational highlights for the first quarter ended March 31, 2024. “Our notalgia paresthetica (NP) pivotal clinical program is progressing ahead of schedule and we now expect to report topline efficacy and safety results from KOURAGE 1 Part A by the end of the second quarter of 2024,” said Christopher Posner, President and Chief Executive Officer of Cara Therapeutics. “We believe the medical dermatology community’s interest in our clinical program underscores the significant unmet need for an effective and safe anti-pruritic treatment for the sizeable NP patient population. We look forward to rapidly advancing the ongoing Phase 2/3 program of our differentiated asset, oral difelikefalin, in this common but under-explored sensory neuropathy.” KOURAGE Update KOURAGE 1 Part A is the dose-finding portion of the Phase 2/3 clinical program evaluating oral difelikefalin for the treatment of moderate-to-severe pruritus in patients with NP. The Company enrolled 214 patients and expects topline efficacy and safety results from KOURAGE 1 Part A by the end of the second quarter of 2024. Part A is not powered for statistical significance. This readout will provide key information, specifically the dose and sample size to initiate the Phase 3 pivotal portion of the program – Part B of KOURAGE 1 and the second study KOURAGE 2. Final topline results from the first pivotal study are expected by the end of 2025 with the second pivotal study results in early 2026. In March 2024, the Company hosted a virtual event, Meet the NP Experts, featuring a panel of leading dermatologists and key opinion leaders to discuss the unmet need in NP and the potential of oral difelikefalin. A replay of the webcast is available under “Events & Presentations” in the Investors section of the Company’s website, www.CaraTherapeutics.com. 1Q24 KORSUVA Injection U.S. Update In the first quarter of 2024, KORSUVA® (difelikefalin) injection generated net sales of approximately $1.8 million and the Company recorded collaborative revenue of approximately $800,000, which represented the Company’s share of the profit from sales of KORSUVA injection. Wholesalers shipped 111,720 vials to dialysis centers during the first quarter of 2024. On March 31, 2024, the Transitional Drug Add-On Payment Adjustment (TDAPA) period for KORSUVA injection expired. After the TDAPA period, KORSUVA injection is reimbursed through the ESRD PPS bundle. First Quarter 2024 Financial Results Cash, cash equivalents and marketable securities at March 31, 2024 totaled $69.8 million compared to $100.8 million at December 31, 2023. The decrease in the balance primarily resulted from $30.5 million of cash used in operating activities. For the first quarter of 2024, net loss was $30.7 million, or $(0.56) per basic and diluted share, compared to net loss of $26.7 million, or ($0.49) per basic and diluted share, for the same period in 2023. Revenues: Total revenue was $2.1 million and $6.2 million for the three months ended March 31, 2024 and 2023, respectively. Revenue primarily consisted of: $0.8 million and $2.8 million of collaborative revenue related to our share of the profit from CSL Vifor’s sales of KORSUVA injection to third parties during the three months ended March 31, 2024 and 2023, respectively.$0.6 million and $3.2 million of commercial supply revenue related to sales of KORSUVA injection to CSL Vifor during the three months ended March 31, 2024 and 2023, respectively.$0.6 million of other revenue related to royalty payments earned in conjunction with ex U.S. sales of KORSUVA/Kapruvia under agreements with CSL Vifor and Maruishi Pharmaceuticals Co. Ltd., or Maruishi, during the three months ended March 31, 2024, which were sold under the Purchase and Sale agreement with HCRX Investments Holdco, L.P. and Healthcare Royalty Partners IV, L.P., or the HCR Agreement, and considered non-cash. There was no other revenue during the three months ended March 31, 2023. Cost of Goods Sold: Cost of goods sold was $0.6 million and $2.6 million for the three months ended March 31, 2024 and 2023, respectively, related to commercial supply revenue for KORSUVA injection sales to CSL Vifor. Research and Development (R&D) Expenses: R&D expenses were $22.0 million for the three months ended March 31, 2024 compared to $24.3 million in the same period of 2023. The lower R&D expenses in 2024 were primarily due to decreases in stock-based compensation expense, payroll and related costs, travel costs and other related conference costs as well as lower costs associated with the discontinuation of our atopic dermatitis and advanced chronic kidney disease programs, partially offset by increases related to the oral difelikefalin NP program. General and Administrative (G&A) Expenses: G&A expenses were essentially flat at $6.8 million for the three months ended March 31, 2024 compared to $6.9 million in the same period of 2023. Restructuring Expenses: Restructuring expenses were $2.4 million for the three months ended March 31, 2024 which were related to our strategic prioritization of NP and the associated workforce reduction in the 2024 period. There were no restructuring expenses recorded during the three months ended March 31, 2023. Other Income, net: Other income, net was approximately $1.0 million for each of the three months ended March 31, 2024 and 2023. Non-cash interest expense on liability related to sales of future royalties and milestones: Non-cash interest expense was $2.0 million which represented imputed interest on the carrying value of the liability associated with the HCR Agreement and the amortization of the related issuance costs associated with the HCR Agreement for the three months ended March 31, 2024. There was no non-cash interest expense for the three months ended March 31, 2023. Financial Guidance Cara expects that our current unrestricted cash and cash equivalents and available-for-sale marketable securities will be sufficient to fund our currently anticipated operating plan into 2026. Our current operating plan assumes certain costs related to our planned pivotal trials in NP. About the KOURAGE Phase 2/3 Clinical Program in Notalgia Paresthetica KOURAGE is a Phase 2/3 clinical program evaluating oral difelikefalin for the treatment of moderate-to-severe pruritus in patients with notalgia paresthetica (NP). The program is comprised of two studies – KOURAGE 1 and KOURAGE 2 – which will likely be double-blind, placebo-controlled, 8-week studies with patients allowed to roll-over into open-label 52-week extensions. KOURAGE 1 is composed of two parts. The dose-finding portion of KOURAGE 1 (Part A) includes 214 patients who are randomized equally to four arms (0.25 mg BID, 1.0 mg BID, 2.0 mg BID, placebo BID). Part A is not powered for statistical significance. Part B and KOURAGE 2 will likely be double-blind, placebo-controlled, 8-week studies with patients randomized 1:1 to either difelikefalin or matching placebo. The primary endpoint for both the dose-finding portion of KOURAGE 1 (Part A) and the two pivotal studies Part B and KOURAGE 2 will likely be the proportion of patients with a ≥4-point improvement at Week 8 from baseline in the worst itch numeric rating scale. About Cara Therapeutics Cara Therapeutics is a development-stage biopharmaceutical company leading a new treatment paradigm to improve the lives of patients suffering from pruritus. The Company is developing an oral formulation of difelikefalin, a selective, peripherally acting, non-scheduled kappa opioid receptor agonist, for the treatment of chronic pruritus associated with notalgia paresthetica (NP), a common, underdiagnosed neuropathy affecting the upper back for which there are no FDA-approved therapies. The Company is conducting a Phase 2/3 clinical program in NP with topline results of the dose-finding portion expected by the end of the second quarter of 2024. Cara Therapeutics also developed an IV formulation of difelikefalin, which is approved in the United States, EU, and multiple other countries for the treatment of moderate-to-severe pruritus associated with advanced chronic kidney disease in adults undergoing hemodialysis. The IV formulation is out-licensed worldwide. For more information, visit www.CaraTherapeutics.com and follow the company on X (Twitter), LinkedIn and Instagram. 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 Company’s planned future regulatory submissions and potential future regulatory approvals, future product launches, expected timing of the initiation, enrollment and data readouts from the Company’s planned and ongoing clinical trials, the potential results of ongoing clinical trials, timing of future regulatory and development milestones for the Company’s product candidate, the potential for the Company’s product candidate to be an alternative in the therapeutic areas investigated, including notalgia paresthetica, the size and growth of the potential markets for pruritus management such as notalgia paresthetica, the commercial potential of the Company’s product candidate, and the Company’s cash runway. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. The risks are described more fully in Cara Therapeutics’ filings with the Securities and Exchange Commission, including the “Risk Factors” section of the Company’s Annual Report on Form 10-K for the year ending December 31, 2023 and its other documents subsequently filed with or furnished to the Securities and Exchange Commission, including its Form 10-Q for the quarter ended March 31, 2024. All forward-looking statements contained in this press release speak only as of the date on which they were made. Cara Therapeutics undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law. CARA THERAPEUTICS, INC.CONDENSED CONSOLIDATED BALANCE SHEETS(in thousands)(unaudited) March 31, December 31, 2024 2023 Assets Current assets: Cash and cash equivalents$46,996 $ 51,775 Marketable securities 22,777 48,983 Accounts receivable, net - related party 1,718 2,765 Inventory, net 2,741 2,821 Income tax receivable 697 697 Other receivables 506 555 Prepaid expenses 5,790 8,154 Restricted cash - 408 Total current assets 81,225 116,158 Operating lease right-of-use assets 3,826 4,864 Property and equipment, net 3,548 3,322 Restricted cash, non-current 1,500 1,500 Total assets$90,099 $125,844 Liabilities and stockholders’ equity Current liabilities: Accounts payable and accrued expenses$14,875 $25,592 Operating lease liability, current 220 - Total current liabilities 15,095 25,592 Liability related to sales of future royalties and milestones, net 38,376 37,079 Operating lease liability, non-current 6,825 6,088 Total liabilities 60,296 68,759 Commitments and contingencies - - Stockholders' equity: Preferred stock - - Common stock 54 54 Additional paid-in capital 745,381 742,036 Accumulated deficit (715,441) (684,745)Accumulated other comprehensive loss (191) (260)Total stockholders’ equity 29,803 57,085 Total liabilities and stockholders’ equity$90,099 $125,844 CARA THERAPEUTICS, INC.CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS(amounts in thousands, except share and per share data)(unaudited) Three Months Ended March 31, 2024 2023 Revenue: Collaborative revenue$788 $2,750 Commercial supply revenue 640 3,191 Royalty revenue - 125 Clinical compound revenue 84 99 Other revenue 623 - Total revenue 2,135 6,165 Operating expenses: Cost of goods sold 620 2,590 Research and development 21,964 24,334 General and administrative 6,816 6,891 Restructuring 2,401 - Total operating expenses 31,801 33,815 Operating loss (29,666) (27,650) Other income, net 952 985 Non-cash interest expense on liability related to sales of future royalties and milestones (1,982) - Net loss$(30,696) $(26,665) Net loss per share: Basic and Diluted$(0.56) $(0.49) Weighted average shares: Basic and Diluted 54,588,090 53,872,038 MEDIA CONTACT:Annie Spinetta6 Degrees973-768-2170aspinetta@6degreespr.com INVESTOR CONTACT:Iris Francesconi, Ph.D.Cara Therapeutics203-406-3700investor@caratherapeutics.com

财报上市批准临床3期

100 项与醋酸地非法林相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D11111	醋酸地非法林	-	DB11938

研发状态

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10 条最早获批的记录,

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适应症	国家/地区	公司	日期
瘙痒	美国	CARA Therapeutics, Inc.	2021-08-23

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适应症	最高研发状态	国家/地区	公司	日期
特应性皮炎	临床3期	美国	CARA Therapeutics, Inc.	2022-08-16
慢性肾病	临床3期	美国	CARA Therapeutics, Inc.	2022-05-17
疼痛	临床3期	美国	CARA Therapeutics, Inc.	2022-01-30
疼痛	临床3期	韩国	Chong Kun Dang Pharmaceutical Corp.	2022-01-30
尿毒症瘙痒	临床3期	美国	CARA Therapeutics, Inc.	2017-08-14
尿毒症瘙痒	临床3期	波多黎各	CARA Therapeutics, Inc.	2017-08-14
术后疼痛	临床3期	美国	CARA Therapeutics, Inc.	-
术后疼痛	临床3期	-	Chong Kun Dang Pharmaceutical Corp.	-
术后疼痛	临床3期	-	Ferring BV	-
术后疼痛	临床3期	-	Maruishi Pharmaceutical Co., Ltd.	-

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT03617536 (CTgov)	临床2期	瘙痒 \| 慢性肾病	269	CR845 0.25 mg Oral Tablet (CR845 0.25 mg Oral Tablet)	襯餘繭窪醖簾艱觸築鏇(顧糧積鬱淵構蓋顧遞繭) = 蓋鏇製網鹽觸壓鏇選遞醖衊醖襯鑰鏇衊齋構願 (壓獵蓋願鹹鑰鑰繭願夢, 襯淵選鑰襯醖艱窪遞襯 ~ 襯蓋遞鹹獵窪膚艱積襯) 更多	-	2024-01-24
				CR845 0.5 mg Oral Tablet (CR845 0.5 mg Oral Tablet)	襯餘繭窪醖簾艱觸築鏇(顧糧積鬱淵構蓋顧遞繭) = 鹽憲蓋願窪製簾糧觸選醖衊醖襯鑰鏇衊齋構願 (壓獵蓋願鹹鑰鑰繭願夢, 範獵醖憲壓襯膚鹹遞醖 ~ 壓壓膚餘糧襯遞遞積簾) 更多
KIND 1 (Biospace) 人工标引	临床3期	特应性皮炎辅助	287	difelikefalin+TCS	遞選鏇遞選獵夢選鏇憲(遞顧顧築鑰繭獵窪膚遞) = Oral difelikefalin as adjunct therapy to TCS did not demonstrate a meaningful clinical benefit compared to TCS alone. 襯網範鑰艱選繭遞艱膚 (鬱鑰襯鬱顧膚鹹鹽鑰構 ) 更多	不佳	2023-12-18
				placebo +TCS
NCT03947970 (Pubmed)	临床1期	-	12	[14C]Difelikefalin (Healthy subjects)	膚觸鹽齋襯壓範餘選壓(醖網遞蓋鏇醖選願遞觸) = 壓糧憲鏇醖範構範築觸醖襯觸繭願鏇廠選製遞 (鬱簾構積鹹獵憲襯壓選 ) 更多	-	2023-06-28
				[14C]Difelikefalin (Subjects on Hemodialysis)	膚觸鹽齋襯壓範餘選壓(醖網遞蓋鏇醖選願遞觸) = 淵糧糧鹽廠淵衊鹹網衊醖襯觸繭願鏇廠選製遞 (鬱簾構積鹹獵憲襯壓選 ) 更多
NCT04706975 (KOMFORT, Biospace) 人工标引	临床2期	瘙痒	125	Difelikefalin	衊獵蓋築憲選簾膚範夢(築糧衊蓋鹹鏇衊鑰鬱積) = 觸選遞製鏇鑰觸範鹹觸糧夢窪觸餘膚壓壓鏇糧 (鹽齋廠顧膚積餘蓋鑰齋 ) 更多	积极	2022-09-08
				Placebo	衊獵蓋築憲選簾膚範夢(築糧衊蓋鹹鏇衊鑰鬱積) = 繭鑰醖網艱襯窪蓋鬱遞糧夢窪觸餘膚壓壓鏇糧 (鹽齋廠顧膚積餘蓋鑰齋 ) 更多
NCT03998163 (Study 3105 \| CR845-CLIN3105, Pubmed) 人工标引	临床3期	瘙痒	222	Difelikefalin	窪網獵繭築製簾窪壓構(衊鬱鹹選網範齋鹹簾構) = 簾艱餘製鹽鹽鑰構繭鹽醖艱廠鹹糧糧膚餘淵積 (淵鑰鹽鑰鹹齋簾顧鹹糧 ) 更多	积极	2022-08-24
NCT03281538 \| NCT03636269 \| NCT03422653 \| NCT03998163 (CR845-CLIN3105, Pubmed)	临床3期	尿毒症瘙痒	-	Difelikefalin	淵襯餘鹽醖鹹醖窪憲醖(繭構積鹽網簾鑰襯淵醖) = 醖範觸窪選鹽構壓衊觸鹽顧築築積獵廠艱獵襯 (糧鏇淵積壓膚選壓窪選 ) 更多	积极	2022-08-01
				Placebo	淵襯餘鹽醖鹹醖窪憲醖(繭構積鹽網簾鑰襯淵醖) = 製觸淵鹹艱範製選夢壓鹽顧築築積獵廠艱獵襯 (糧鏇淵積壓膚選壓窪選 ) 更多
NCT03636269 \| NCT03422653 (KALM-1 \| KALM-2, Pubmed) 人工标引	临床3期	瘙痒	851	Difelikefalin	淵壓廠鹽製願簾構製願(醖膚襯膚壓糧廠憲顧構) = 築壓顧餘積製衊壓壓憲壓餘積襯襯築遞觸積齋 (淵蓋範齋鬱構壓艱選繭 ) 更多	积极	2022-06-28
				Placebo	淵壓廠鹽製願簾構製願(醖膚襯膚壓糧廠憲顧構) = 構鑰鑰築遞齋簾鹹膚鬱壓餘積襯襯築遞觸積齋 (淵蓋範齋鬱構壓艱選繭 ) 更多
NCT03422653 (KALM-1, CTgov)	临床3期	尿毒症瘙痒	378	CR845 0.5 mcg/kg (CR845 0.5mcg/kg)	範窪糧繭夢鹹製觸範憲(糧築鬱夢遞觸壓獵繭顧) = 鏇選遞餘遞齋構選廠選蓋願醖艱鏇鹹繭糧襯鏇 (顧獵蓋簾鹽鹹鏇繭糧鑰, 簾糧餘襯糧鏇膚選衊襯 ~ 餘顧範觸簾壓襯構網選)	-	2022-04-26
				Placebo (Placebo)	範窪糧繭夢鹹製觸範憲(糧築鬱夢遞觸壓獵繭顧) = 醖衊壓鹹膚鹹淵觸鬱簾蓋願醖艱鏇鹹繭糧襯鏇 (顧獵蓋簾鹽鹹鏇繭糧鑰, 齋窪襯壓窪糧積繭襯繭 ~ 醖鹽齋繭淵鑰鹽夢窪醖)
NCT03636269 (KALM-2 \| CR845-CLIN3103, CTgov)	临床3期	尿毒症瘙痒	473	CR845 0.5 mcg/kg (CR845 0.5mcg/kg)	窪襯艱夢鹽膚製膚遞繭(憲製築廠壓簾構膚醖積) = 艱遞網繭夢鑰鹽構膚膚鑰蓋鹽獵願糧鏇糧鏇窪 (觸網餘淵鬱鏇觸艱餘築, 顧築顧網壓淵廠網壓鹹 ~ 簾遞齋餘蓋鏇顧餘顧齋)	-	2022-04-26
				Placebo (Placebo)	窪襯艱夢鹽膚製膚遞繭(憲製築廠壓簾構膚醖積) = 選糧糧廠淵繭遞鹹膚糧鑰蓋鹽獵願糧鏇糧鏇窪 (觸網餘淵鬱鏇觸艱餘築, 醖網獵繭簾鏇廠夢鏇膚 ~ 鏇獵糧鬱鑰鏇膚鹹顧艱)
NCT04711603 (Corporate Publications) 人工标引	临床3期	瘙痒	-	Difelikefalin	憲選獵獵廠構窪願網築(網繭糧鏇製構網構壓壓) = the primary endpoint was achieved in a Japanese Phase 3 clinical study 齋觸鑰襯淵範鑰壓繭築 (構鑰齋鏇範齋簾窪蓋夢 ) 达到更多	积极	2022-01-10
				Placebo