A Phase 3, multicenter, open-label, single-arm, extension study to evaluate the long-term safety and tolerability of cenerimod in adult subjects with moderate-to-severe systemic lupus erythematosus (SLE) on top of background therapy (OPUS OLE) - ID-064A303

开始日期2024-11-13

申办/合作机构

Idorsia Pharmaceuticals Ltd.

NCT06475742

/ Enrolling by invitation临床3期

A Phase 3, Multicenter, Open-label, Single-arm, Extension Study to Evaluate the Long-term Safety and Tolerability of Cenerimod in Adult Subjects With Moderate-to-Severe Systemic Lupus Erythematosus (SLE) on Top of Background Therapy

The goal of this clinical study is to learn about the long-term safety and tolerability of cenerimod in adult patients with moderate to severe symptoms of systemic lupus erythematosus.
The main questions it aims to answer are:
* Whether cenerimod causes any adverse effects ('side effects') when given on top of drugs already being given for systemic lupus erythematosus.
* How well cenerimod works to reduce symptoms of systemic lupus erythematosus when taken for at least 1 year and up to 3 years.
Participants taking part in this study will have already taken part in another study, where they received either cenerimod or placebo (look-alike substance containing no active drug) for 1 year.
In this clinical study approximately 680 participants will receive cenerimod (on top of drugs already being given for systemic lupus erythematosus) for at least 1 year and up to 3 years.

开始日期2024-07-30

申办/合作机构

Idorsia Pharmaceuticals Ltd.

NCT05672576

/ Recruiting临床3期

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy, Safety, and Tolerability of Cenerimod in Adult Subjects With Moderate-to-severe Systemic Lupus Erythematosus (SLE) on Top of Background Therapy

The goal of this clinical trial is to see how well cenerimod reduces symptoms of Systemic Lupus Erythematous in adult patients with moderate to severe symptoms. The main questions it aims to answer are:
* How well cenerimod works on top of the treatment already being administered.
* How safe cenerimod is for adult patients with Systemic Lupus Erythematosus.
Researchers will compare one dose of cenerimod and a placebo to see how well cenerimod works when it is added to the treatment already being administered.
In this research study approximately 210 participants will receive cenerimod and approximately 210 participants will receive placebo for 12 months.

开始日期2023-06-26

申办/合作机构

Idorsia Pharmaceuticals Ltd.

100 项与 Cenerimod 相关的临床结果

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100 项与 Cenerimod 相关的转化医学

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100 项与 Cenerimod 相关的专利（医药）

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项与 Cenerimod 相关的文献（医药）

2025-01-01·The Lancet Rheumatology

Cenerimod, a sphingosine-1-phosphate receptor modulator, versus placebo in patients with moderate-to-severe systemic lupus erythematosus (CARE): an international, double-blind, randomised, placebo-controlled, phase 2 trial

Article

作者: D'Cruz, David ; Trokan, Luba ; Strasser, Daniel S ; Murphy, Mark J ; Berkani, Ouali ; Askanase, Anca D ; Merrill, Joan T ; Cahuzac, Clélia ; Navarra, Sandra V ; Cornelisse, Peter ; Kalunian, Kenneth

BACKGROUNDSphingosine-1-phosphate (S1P) is a signalling molecule that has an inhibitory role in atherosclerosis, inflammation, cell proliferation, and immunity. Cenerimod is a selective S1P₁ receptor modulator under investigation for the treatment of systemic lupus erythematosus (SLE). We aimed to determine the efficacy, safety, and tolerability of four doses of cenerimod in adults with moderate-to-severe SLE receiving standard of care background therapy.METHODSCARE was a double-blind, randomised, placebo-controlled, phase 2 trial, in adults (aged 18-75 years) with moderate-to-severe SLE (a score of at least 6 out of 105 on the SLE disease activity index-2000, modified to exclude leukopenia [mSLEDAI-2K] score). Participants were recruited from 189 hospitals, specialist centres, and outpatient clinics in 22 countries in Asia Pacific, Latin America, Europe, and the USA. Participants were randomly assigned (1:1:1:1:1), using an interactive response technology via balanced block randomisation (block size of 5) and stratified by oral glucocorticoid dose at randomisation and disease activity at screening, to once-daily oral cenerimod at 0·5 mg, 1·0 mg, 2·0 mg, or 4·0 mg or placebo, in addition to stable background SLE therapy, and followed up for 12 months. After 6 months, participants assigned to cenerimod 4·0 mg were randomly assigned again (1:1) to either cenerimod 2.0 mg or placebo for a further 6 months. The primary endpoint was change from baseline to month 6 in mSLEDAI-2K score, assessed in all participants randomly assigned to treatment (full analysis set). To meet the primary endpoint, the doses had to show a significant improvement over placebo, when adjusting for multiplicity, considering the hierarchical testing strategy, per a prespecified plan. Safety analyses included all participants who received at least one dose of study treatment. This study is registered with ClinicalTrials.gov, NCT03742037, and is complete.FINDINGSBetween Dec 21, 2018, and Aug 25, 2022, 810 patients were screened and 427 were randomly assigned to 0·5 mg (n=85), 1·0 mg (n=85), 2·0 mg (n=86), and 4·0 mg (n=85) cenerimod or placebo (n=86). Median age was 42 years (IQR 33-51), 406 (95%) of 427 participants were women, 21 (5%) were men, and 337 (79%) were White. At month 6, the least squares mean change from baseline in mSLEDAI-2K score was -2·85 (95% CI -3·60 to -2·10) for the placebo group and -3·24 (-3·98 to -2·49; difference vs placebo -0·39 [95% CI -1·45 to 0·68]; p=0·47) for the cenerimod 0·5 mg group, -3·41 (-4·16 to -2·67; difference vs placebo -0·57 [-1·62 to 0·49]; p=0·29) for the 1·0 mg group, -2·84 (-3·58 to -2·09; difference vs placebo 0·01 [-1·05 to 1·08]; p=0·98) for the 2·0 mg group, and -4·04 (-4·79 to -3·28; difference vs placebo -1·19 [-2·25 to -0·12]; p=0·029) for the 4·0 mg group; hence, the primary endpoint was not met. Treatment-emergent adverse events up to 12 months had no clear treatment-related or dose-related pattern across the groups. At month 6, treatment-emergent lymphopenia was reported in one (1%) of 85 patients who received cenerimod 0·5 mg, five (6%) of 85 patients who received 1·0 mg, nine (10%) of 86 patients who received 2·0 mg, 12 (14%) of 84 patients who received 4·0 mg, and no patients who received placebo. Two deaths due to adverse events occurred (both in the cenerimod 1·0 mg group; one due to acute coronary syndrome and the other due to upper gastrointestinal haemorrhage), and were determined to be unrelated to study treatment.INTERPRETATIONThe primary endpoint was not met. Cenerimod was well tolerated over 12 months. Cenerimod 4·0 mg is being investigated for the treatment of SLE in two ongoing phase 3 trials (NCT05648500, NCT05672576).FUNDINGIdorsia Pharmaceuticals.

2024-12-03·Cureus

Evolving Treatment Strategies for Systemic Lupus Erythematosus in Clinical Practice: A Narrative Review

Review

作者: Hawkins, Alison M ; Patel, Chandni R ; Kaye, Alan D ; Shekoohi, Sahar ; Kaye, Adam M ; Upshaw, William C ; Ahmadzadeh, Shahab ; Bembenick, Kristin Nicole ; Varrassi, Giustino ; Tassin, Joseph P ; Burroughs, Caroline R ; Mosieri, Chizoba N

Systemic lupus erythematosus (SLE) is an autoimmune disease that more commonly affects African American people, although it is seen in people of all racial backgrounds. This condition is characterized by a dysregulated immune response resulting in widespread inflammation. Clinical manifestations caused by this inflammation include arthritis, anemia, cutaneous rashes, pleuritis, and nephritis. Treatment for SLE aims to reduce disease activity and maintain a state of low inflammation. In this regard, numerous treatments are used, such as hydroxychloroquine, glucocorticoids, and non-glucocorticoid immunosuppressants such as methotrexate. Related to these drugs resulting in significant adverse effects and being ineffective in controlling SLE symptoms in some patients, new biologic agents have been created in hopes of better treating SLE. This includes belimumab and anifrolumab, monoclonal antibodies directed against the cytokine, and type 1 interferon receptor, respectively. These agents are indicated in patients with SLE whose symptoms are inadequately controlled by standard therapy alone. Clinical trials have shown that these agents effectively reduce SLE symptoms as judged using standardized metrics of disease activity. These biological agents have also been shown to have generally mild side effects when taken by patients with SLE, making them safe for use. In addition to the above medications, new treatments are being developed for SLE patients, such as cenerimod, litifilimab, chimeric antigen receptor T cells, and DS-7011a (anti-toll-like receptor 7 monoclonal antibody). These new treatments have shown promise in clinical trials. However, more information regarding their safety and efficacy is needed before they are available for the treatment of SLE.

2024-12-01·The Journal of Clinical Pharmacology

Multiple‐dose pharmacokinetics of cenerimod and the effect of charcoal on its elimination

Article

作者: Mueller, Markus S. ; Dingemanse, Jasper ; Juif, Pierre‐Eric ; Charfi, Hakim

AbstractCenerimod is a sphingosine‐1‐phosphate receptor 1 modulator that reduces tissue availability of circulating lymphocytes. The compound is in Phase 3 development for the treatment of systemic lupus erythematosus. Its pharmacokinetic properties are characterized by slow absorption and multiphasic elimination with a long terminal half‐life (t½), potentially caused by enterohepatic circulation (EHC). In this trial in healthy participants, oral cenerimod 0.5 and 4 mg once daily was administered for 50 days, followed by oral administration of activated charcoal (ie, 50 mg every 12 h for 11 days, starting 24 h after the last cenerimod dose), to investigate the potential EHC of cenerimod and assess whether elimination of cenerimod can be accelerated. The multiple‐dose pharmacokinetics, pharmacodynamics, safety, and tolerability of cenerimod were also evaluated. For both doses, peak plasma concentrations were reached 6 and 7 h after dosing. Cenerimod accumulated approximately eightfold and (near) steady‐state conditions were reached after 50 doses, resembling clinically meaningful exposure to cenerimod. The t½ following 0.5 and 4 mg of cenerimod was 767 and 799 h (ie, 32 and 33 days) and 720 and 780 h (ie, 30 and 33 days) with or without administration of charcoal, respectively, indicating no statistically significant difference. Therefore, charcoal did not accelerate cenerimod elimination suggesting that there is no EHC of cenerimod. A reversible, dose‐dependent decrease in total lymphocyte count was observed. No safety concerns were identified; administration of charcoal was well tolerated.

项与 Cenerimod 相关的新闻（医药）

2024-12-20

·GlobeNewswire-Health Care

Idorsia provides update on the exclusive negotiations for the global rights to aprocitentan

Ad hoc announcement pursuant to Art. 53 LR Company announces delay to the targeted timeline for signing a binding agreementCompany in discussions with bondholders to restructure the company’s outstanding debt and extend the operational cash runway Allschwil, Switzerland – December 20, 2024Idorsia Ltd (SIX: IDIA) today provided an update on the ongoing exclusive negotiations for the global rights to aprocitentan. On November 27, 2024, the company announced that it had entered exclusive negotiations with an undisclosed party for global rights to aprocitentan that resulted in an exclusivity fee of USD 35 million paid in early December. At that time, the company was targeting signing an agreement before the end of 2024 and closing in early 2025, with more details to be shared should a final agreement be signed. In addition, the company announced plans to streamline its business to reduce costs and restructure its outstanding debt. Idorsia believes signing will not be achieved in 2024. Negotiations with the undisclosed party continue, however the company cannot guarantee that an agreement can be reached. As a result, the company is considering options to extend the company’s operational cash runway to bridge to a potential binding offer, as well as all strategic options. André C. Muller, CEO of Idorsia, commented: “Signing the agreement for aprocitentan is a crucial first step to ensure the future of Idorsia. Based on our current liquidity forecasts, there are additional prerequisites to allow the company to continue to operate, which include the completion of the recently announced company restructuring; the restructuring of the company’s outstanding debt, including the 2025 and 2028 convertible bonds; and raising additional funding. As a result of these constraints and the delay to the completion of the aprocitentan agreement, we are also considering all strategic options beyond a deal for aprocitentan.” Convertible Bond restructuringThe company has issued two convertible bonds which rank pari-passu, the first with a nominal value of CHF 200 million and a conversion price of CHF 6.00 per Idorsia share, maturing on January 17, 2025 (CB 2025), the second with a nominal value of CHF 600 million and a conversion price of CHF 31.54, maturing on August 4, 2028, although investors may request redemption of the bonds as of August 4, 2026 (CB 2028). Given the near-term maturity and the inability of the company to repay the bonds at this time, an extension to the CB 2025 is required whatever the outcome of the ongoing negotiation regarding the rights to aprocitentan. The company is in discussions with certain holders of the CB 2025 and the CB 2028 to amend the terms of both instruments following an extension of the CB 2025. Company restructuringFollowing a consultation process with employee representatives at headquarters a reduction of approximately 250 positions globally is anticipated. The company has already begun the implementation of the restructuring and expects the cost reduction to be largely effective by Q2 2025. Additional fundingIdorsia expects to close 2024 with cash of at least CHF 70 million including the USD 35 million exclusivity fee. The company could end 2024 with cash of around CHF 100 million, should an additional deal close in the coming days. Should the potential agreement for the rights to aprocitentan conclude in a timely manner, in-line with the upfront payment anticipated in the non-binding offer, and subject to the CB 2025 restructuring, Idorsia would be funded until mid-2025. The company is diligently seeking additional funding of at least CHF 200 million to extend its operational cash runway into at least 2026. Updated guidance for 2024For 2024 – excluding unforeseen events and broadly in-line with previously issued guidance – the company expects QUVIVIQ net sales of around CHF 55 million, SG&A expenses of around CHF 265 million, R&D expense of around CHF 130 million for Idorsia-led pipeline assets, leading to non-GAAP operating expenses around CHF 400 million. This performance would result in an Idorsia-led business non-GAAP operating loss of around CHF 350 million. The company expects a US GAAP operating loss for 2024 of around CHF 260 million which includes a one-off benefit of CHF 125 million from the agreement with Viatris on selatogrel and cenerimod and an estimated restructuring charge of CHF 10 million. Guidance for 2024 in CHF million* Idorsia-led business Partner-led business Global BusinessREVENUE 55 50 105COGS -10 -30 -40SG&A OPEX -265 – -265R&D OPEX -130 0 -130Non-GAAP EBIT -350 20 -330D&A -30 – -30SBC -15 – -15Other -10 125 115US-GAAP EBIT -405 145 -260 *Excluding unforeseen events Notes to the editor About the 2025 convertible bondOn July 17, 2018, Idorsia raised CHF 200 million through the issuance of convertible bonds to fund the Phase 3 development of aprocitentan, clazosentan, lucerastat and daridorexant, as well as the early-stage and preclinical pipeline. The bonds initially had a term of six years, maturing on July 17, 2024. On May 6, 2024, a bondholders’ meeting approved modifications to the terms of the convertible bonds to, among others, amend the conversion price to CHF 6.00 per Idorsia share (from CHF 33.95) and extend the maturity date by six months to January 17, 2025. About the 2028 convertible bondOn August 4, 2021, Idorsia raised CHF 600 million through the issuance of convertible bonds to support the commercial product launches in several key markets and to fund the further development of the late-stage pipeline. The bonds have a conversion price of CHF 31.54 and a term of seven years, maturing on August 4, 2028. Investors may request redemption of the bonds as of the 5th anniversary of the settlement date. About IdorsiaIdorsia Ltd is reaching out for more – we have more passion for science, we see more opportunities, and we want to help more patients. The purpose of Idorsia is to challenge accepted medical paradigms, answering the questions that matter most. To achieve this, we will discover, develop, and commercialize transformative medicines – either with in-house capabilities or together with partners – and evolve Idorsia into a leading biopharmaceutical company, with a strong scientific core. Headquartered near Basel, Switzerland – a European biotech hub – Idorsia has a highly experienced team of dedicated professionals, covering all disciplines from bench to bedside; QUVIVIQ™ (daridorexant), a different kind of insomnia treatment with the potential to revolutionize this mounting public health concern; strong partners to maximize the value of our portfolio; a promising in-house development pipeline; and a specialized drug discovery engine focused on small-molecule drugs that can change the treatment paradigm for many patients. Idorsia is listed on the SIX Swiss Exchange (ticker symbol: IDIA). For further information, please contactAndrew C. WeissSenior Vice President, Head of Investor Relations & Corporate CommunicationsIdorsia Pharmaceuticals Ltd, Hegenheimermattweg 91, CH-4123 Allschwil+41 (0)58 844 10 10investor.relations@idorsia.commedia.relations@idorsia.com www.idorsia.com The above information contains certain “forward-looking statements”, relating to the company’s business, which can be identified by the use of forward-looking terminology such as “estimates”, “believes”, “expects”, “may”, “are expected to”, “will”, “will continue”, “should”, “would be”, “seeks”, “pending” or “anticipates” or similar expressions, or by discussions of strategy, plans or intentions. Such statements include descriptions of the company’s investment and research and development programs and anticipated expenditures in connection therewith, descriptions of new products expected to be introduced by the company and anticipated customer demand for such products and products in the company’s existing portfolio. Such statements reflect the current views of the company with respect to future events and are subject to certain risks, uncertainties and assumptions. Many factors could cause the actual results, performance or achievements of the company to be materially different from any future results, performances or achievements that may be expressed or implied by such forward-looking statements. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described herein as anticipated, believed, estimated or expected. Attachment Press Release PDF

财报

2024-12-12

·药精通Bio

自免疾病: 系统性红斑狼疮 (SLE) 的靶向治疗进展

系统性红斑狼疮（SLE，Systemic lupus erythematosus）通常称为狼疮，是一种累及多系统的系统性自身免疫性疾病，具有显著的发病率和死亡率。系统性红斑狼疮患者经常会经历疾病发作和缓解的交替时期。SLE 的表现多种多样，从皮疹和关节炎到贫血和血小板减少，再到浆膜炎、肾炎、癫痫发作和精神病。据估计，大约 90% 的 SLE 患者是女性，大多数病例年龄在 15 至 44 岁之间。SLE 女性怀孕被认为是高风险，与一般人群相比，孕产妇和新生儿的发病率和死亡率较高。近年来，精细免疫表型、全基因组关联研究（GWAS）、单细胞测序、多组学分析和基因编辑的进展显着增强了对SLE发病机制的理解。这些技术突破还推动了针对免疫细胞、共刺激分子、细胞因子和信号转导途径的疗法的开发和临床研究，包括单克隆抗体、小分子药物和嵌合抗原受体（CAR-）T细胞免疫疗法。贝利木单抗（Belimumab）和阿尼鲁单抗（Anifrolumab）等治疗方法的批准为临床医生、研究人员和患者提供了更大的信心和更多的选择来治疗中度至重度系统性红斑狼疮，特别是难治性病例。１.　FDA 已批准 SLE 靶向治疗Belimumab（Benlysta） Belimumab（Benlysta）由 GSK 开发，是第一个 B 淋巴细胞刺激剂（BlyS）的靶向抑制剂。通过与 BlyS 结合，Belimumab 抑制 B 细胞（包括自身反应性 B 细胞）的存活，并减少其分化为负责产生免疫球蛋白的浆细胞，尽管它不直接与 B 细胞结合。贝利木单抗最初于 2011 年 3 月获得 FDA 批准用于治疗 SLE，是首个 SLE 靶向疗法，贝利木单抗于 2020 年 12 月获得扩大批准用于治疗狼疮性肾炎。它通常与羟氯喹（Plaquenil）和吗替麦考酚酯（CellCept）等其他药物联合使用，以增强治疗效果。Anifrolumab（Saphnelo） Saphnelo（anifrolumab）是一种全人源单克隆抗体，可与 I 型 IFN 受体的亚基 1 结合，有效阻断 I 型 IFN 的活性。I 型 IFN，例如 IFN-α、IFN-β 和 IFN-κ，是参与调节 SLE 相关炎症途径的细胞因子。在大多数成年 SLE 患者中观察到 I 型 IFN 信号传导活性增加，并且与疾病严重程度相关。作为“首创新药”I 型 IFN 受体拮抗剂，Saphnelo 代表了 SLE 治疗的重大进步。2021年8月2日，美国FDA批准Saphnelo用于治疗中重度SLE。２.　治疗 SLE 的靶向疗法正在开发中表 1. 治疗系统性红斑狼疮的靶向疗法聚乙二醇化抗体 - Dapirolizumab Dapirolizumab pegol 是一种新型研究中人源化无 Fc聚乙二醇 (PEG) 缀合的抗原结合 (Fab') 片段。它抑制 CD40L 信号传导，已被证明可以减少 B 细胞活化和自身抗体产生，减轻 IFN-I 分泌，并减弱 T 细胞和抗原呈递细胞 (APC) 活化。 2024 年 9 月 24 日，UCB 和 Biogen 联合宣布 III 期 PHOENYCS GO 研究评估 dapirolizumab pegol 治疗 SLE 的效果积极。 PHOENYCS GO 是一项多中心、随机、双盲、安慰剂对照、平行的 III 期试验，旨在评估dapirolizumab联合标准护理 (SOC) 疗法与安慰剂加 SOC 疗法在患有以下疾病的患者中的疗效和安全性，包括中度至重度系统性红斑狼疮，共有 321 名患者参与了该研究。分析显示，dapirolizumab pegol 与 SOC 相结合，达到了其主要终点。BICLA方法评估中，第 48 周时，与安慰剂加 SOC 相比，患者的中度至重度疾病活动度显著改善。BICLA 是一个既定的复合终点，用于通过患者病史、临床检查和实验室测试评估临床疾病活动性。此外，评估疾病活动和耀斑的关键次要终点显示出具有临床意义的改善。 dapirolizumab pegol 的安全性与之前的研究一致，并且与接受免疫调节治疗的 SLE 患者的预期安全结果一致。Litifilimab（利替非利单抗） Litifilimab (BIIB059) 由 Biogen 开发，是一种靶向 BDCA2 的全人源化 IgG1 mAb。通过抑制 BDCA2，它可以减少炎症细胞因子（包括 IFN-I）的产生，在调节 SLE 的病理机制中发挥着至关重要的作用。Litifilimab　是目前最先进的BDCA2靶向疗法，已进入治疗皮肤红斑狼疮（CLE）和SLE的III期临床试验。图 1. Litifilimab 的作用机制在一项涉及 SLE 参与者的 2 期试验中，在 24 周内，与安慰剂相比，litifilimab 与基线相比，肿胀和压痛关节的数量有更大程度的减少。需要更长时间和更大规模的试验来确定Litifilimab治疗 SLE 的安全性和有效性。JAK 抑制剂 - Upadacitinib Upadacitinib 是一种选择性、可逆性 JAK 抑制剂，正在研究用于治疗各种严重的免疫介导的炎症性疾病。在细胞和酶活性测定中，与 JAK2、JAK3 和 TYK2 相比，upadacitinib 对 JAK1 显示出特异的强的抑制作用。该药物已被批准用于治疗成人中度至重度类风湿性关节炎、银屑病关节炎、溃疡性结肠炎和强直性脊柱炎。 2023 年，艾伯维宣布了 upadacitinib 的 2 期临床试验取得积极结果，该试验可作为单一疗法或联合使用（elsubrutinib 60 mg 和 upadacitinib 30 mg），用于治疗继续接受标准狼疮治疗的中度至重度 SLE 成人的疗法。基于这些结果，艾伯维表示将推进upadacitinib进入SLE治疗的3期临床试验。S1P1 调节剂 - Cenerimod Cenerimod 是一种潜在的“FIC”、高选择性 S1P1 受体调节剂。这种每日一次的口服片剂正在开发用于治疗系统性红斑狼疮。2022 年 12 月，Idorsia 启动了 OPUS 项目，该项目由两项多中心、随机、双盲、安慰剂对照 3 期试验组成，旨在评估 cenerimod 与中重度 SLE 成人患者的疗效、安全性和耐受性。Cenerimod 已获得美国 FDA 授予的治疗 SLE 的快速通道资格。在 II 期临床试验中，测试的最高剂量为 4 mg，六个月后，与安慰剂相比，治疗组在主要终点（mSLEDAI-2K 评分）上显示出数值改善。然而，除了 4 mg 剂量（p＝ 0.029）外，其他组中没有观察到显着差异。此外，在第 52 周时，所有试验组的 mSLEDAI-2K 和 SRI-4 评分均未发现显著差异。细胞治疗 - KYV-101 KYV-101 是一种新型全人源抗 CD19 嵌合抗原受体 (CAR) T 细胞疗法，旨在用于 B 细胞驱动的自身免疫性疾病。它专门靶向 CD19，这是一种在 B 细胞表面表达的蛋白质。B 细胞除了与许多类型的恶性肿瘤有关，也与自身免疫性疾病相关。 References: [1] Dapirolizumab Pegol Phase 3 Data Presented at the American College of Rheumatology Shows Significant Reduction in Systemic Lupus Erythematosus Disease Activity .[2] Trial of Anti-BDCA2 Antibody Litifilimab for Systemic Lupus Erythematosus,10.1056/NEJMoa2118025 [3]Phase 2 Study of Upadacitinib (RINVOQ®) Alone or as a Combination Therapy Meets Primary and Key Secondary Endpoints in Patients with Systemic Lupus Erythematosus [4] Encouraging Phase 2 data on cenerimod – Idorsia's S1P1 receptor modulator currently investigated for SLE – presented at ACR 2019 END 免责声明：本文仅作知识交流与分享及科普目的，不涉及商业宣传，不作为相关医疗指导或用药建议。文章如有侵权请联系删除。 OTC2024类器官前沿应用与3D细胞培养论坛圆满落幕，点击图片可查看会后报告，咨询OTC2025类器官论坛请联系：王晨 180 1628 8769

免疫疗法细胞疗法临床研究临床结果

2024-11-19

·PRNewswire

Systemic Lupus Erythematosus Clinical Trial Pipeline Gains Momentum as 120+ Key Companies at the Forefront | DelveInsight

Systemic Lupus Erythematosus (SLE) is a chronic autoimmune disease characterized by inflammation and tissue damage across multiple organ systems, such as the skin, joints, kidneys, heart, and brain. The incidence of autoimmune diseases, including SLE, has been increasing globally, with a significant impact on demand for targeted and effective therapies. LAS VEGAS, Nov. 19, 2024 /PRNewswire/ -- DelveInsight's ' Systemic Lupus Erythematosus Pipeline Insight 2024 ' report provides comprehensive global coverage of pipeline systemic lupus erythematosus therapies in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the systemic lupus erythematosus pipeline domain. Key Takeaways from the Systemic Lupus Erythematosus Pipeline Report DelveInsight's systemic lupus erythematosus pipeline report depicts a robust space with 120+ active players working to develop 140+ pipeline therapies for systemic lupus erythematosus treatment. Key systemic lupus erythematosus companies such as Roche, ImmuPharma, UCB, Idorsia Pharmaceuticals, Biogen, AbbVie, Bristol-Myers Squibb, Vera Therapeutics, Beijing Mabworks Biotech Co., Ltd., BeiGene, Jiangsu Renocell Biotech Company, AstraZeneca, Pfizer, Red de Terapia Celular, Kira Pharmacenticals (US), LLC., Jemincare, Galapagos NV, Alumis, argenx, Gilead Sciences, Novartis, Zenas Biopharma, Horizon Therapeutics, Provention Bio, Janssen Research & Development, Eli Lilly and Company, Medsenic, Sanofi, Merck KGaA, Resolve Therapeutics, ILTOO, Janssen, Alpine Immune Sciences, Kezar Life Sciences, Neovacs, Kangpu Biopharmaceuticals, Cartesian Therapeutics, Apellis Pharmaceuticals, Inc., Alexion Pharmaceuticals, Inc., Q32 Bio Inc., Conduit Pharmaceuticals, Miltenyi Biomedicine GmbH, Kyverna Therapeutics, ImmPACT Bio, Genrix (Shanghai) Biopharmaceutical Co., Ltd., Gracell Biotechnologies (Shanghai) Co., Ltd., Cabaletta Bio, Tenet Medicines, Ascentage Pharma Group Inc., InnoCare, Eisai, Sorrento Therapeutics, Carna Bioscience, Yake Biotechnology, Equillium, Daiichi Sankyo Company, SinoMab Bioscience Ltd, Citryll BV, Sareum, Shanghai Junshi Biosciences, Chia Tai Tianqing Pharmaceutical Group Co., Ltd., Millennium Pharmaceuticals, Inc., Takeda, Synthekine, Hangzhou Sumgen Biotech Co., Ltd., Sana Biotechnology, Hoffmann-La Roche, Guangdong Ruishun Biotech Co., Ltd, Shanghai Ming Ju Biotechnology Co., Ltd., Autolus Limited, Nkarta, Inc., Luminary Therapeutics, Kyowa Kirin Co., Ltd., Shanghai Ming Ju Biotechnology, IGM Biosciences, Inc., GlaxoSmithKline, Fate Therapeutics, Cugene Inc., Century Therapeutics, Inc., Cullinan Therapeutics Inc., Juno Therapeutics, Inc., EdiGene Inc., Atara Biotherapeutics, Annexon, Inc., Adicet Therapeutics, Bioray Laboratories, PersonGen BioTherapeutics (Suzhou) Co., Ltd., Juventas Cell Therapy Ltd., Nanjing Bioheng Biotech Co., Ltd., Pregene ShenZhen Biotechnology, Artiva Bio, KeyMed Biosciences, IASO, JW Therapeutics, ROME Therapeutics, Ventus Therapeutics, Allosite Therapeutics, iCell Gene Therapeutics, Caribou Biosciences, LongBio Pharma, Amytrx Therapeutics, Corestem, Eliem Therapeutics, SinoMab Bioscience Ltd., and others are evaluating new systemic lupus erythematosus drugs to improve the treatment landscape. Promising systemic lupus erythematosus pipeline therapies such as Obinutuzumab, Lupuzor (IPP-201101), Dapirolizumab pegol, Cenerimod, BIIB059, Upadacitinib, Deucravacitinib, Atacicept, MIL62, Zanubrutinib, RY_SW01 cell injection|Basic treatment, Ravulizumab, Rapcabtagene autoleucel, PF-06823859, Mesenchymal stem cells (MSC), KP104, JMKX000189, Iptacopan, GLPG3667, ESK-001, Elsubrutinib, Efgartigimod alfa, Edecesertib, Ianalumab, Obexelimab (XmAb5871), Daxdilimab (VIB7734), PRV-3279, Nipocalimab, ABBV 599, NKTR-358 (LY3471851), Arscimed, SAR441344, Enpatoran, RSLV-132, Aldesleukin, Daratumumab, Branebrutinib, BMS-986256, ALPN-101, KZR-616, IFNα kinoid, KPG 818, Descartes-08, CFZ533, APL-2, ALXN2050, ADX-097, AZD1656, MB-CART19.1, KYV-101, IMPT-514, GR1603, GC012F Injection, CABA-201, Budoprutug, APG-2575, ICP-022, E6742, ALPN-303, AC0058, Mosunetuzumab, AS-0871, CD19/BCMA CAR T-cells, PF-06835375, EQ001 (Itolizumab), DS-7011a, SM03, CIT-013, SDC-1801, UBP1213, TQB3702, TAK-079, TAK-007, SYNCAR-001, SG301, SC291, RO7507062, RJMty19 (CD19-CAR-DNT cells), Relma-cel, PIT565, Obecabtagene autoleucel (obe-cel), NKX019, LMY-920, KK4277, JWCAR201, Imvotamab, GSK4527363, GSK4347859, FT819, CUG252, CNTY-101, CLN-978, CC-97540, Belantamab, ATHENA CAR-T ATA3219, ANX009, ADI-001, BRL-301, T-cell injection targeting CD19 chimeric antigen receptor, CNCT19, RD06-04, PRG-2311, PRG-1801, AlloNK, CM313, CT103A, JWCAR 029, Research program: endogenous reverse transcriptase inhibitors, VENT 03, ONT01, BCMA-CD19 cCAR T cells, CB-010, LP-005, AMTX 100, CE211AT15, TN-119, SN1011, QX002N, RSLV-145, Recombinant human plasma gelsolin, LN-008, TST 008, IBL 100s, and others are under different phases of systemic lupus erythematosus clinical trials. In October 2024, the FDA approved the investigational new drug (IND) application for Cullinan Therapeutics' CLN-978 to treat systemic lupus erythematosus (SLE). In September 2024, Cartesian Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease Designation to Descartes-08 for the treatment of juvenile dermatomyositis (JDM). In September 2024, Caribou Biosciences announced that the U.S. Food and Drug Administration (FDA) had granted fast-track designation to CAR T-cell therapy CB-010 for systemic lupus erythematosus (SLE). In September 2024, UCB and Biogen reported successful results from their Phase III clinical trial of the PHOENYCS GO study, which tested dapirolizumab pegol as a treatment for moderate-to-severe systemic lupus erythematosus. In August 2024, Conduit Pharmaceuticals announced they will be conducting a Phase IIa clinical trial to evaluate AZD1656 for the treatment of multiple autoimmune diseases, including systemic lupus erythematosus (SLE). In July 2024, the first individual received the therapy Descartes-08 to treat systemic lupus erythematosus. This therapy has been previously administered to patients with myasthenia gravis, a long-term autoimmune disorder characterized by muscle weakness. In February 2024, Idorsia Pharmaceuticals formed a major global research and development partnership with Viatris to advance and commercialize two Phase III assets, selatogrel and cenerimod, on a global scale. Request a sample and discover the recent advances in systemic lupus erythematosus treatment drugs @ Systemic Lupus Erythematosus Pipeline Report The systemic lupus erythematosus pipeline report provides detailed profiles of pipeline assets, a comparative analysis of clinical and non-clinical stage systemic lupus erythematosus drugs, inactive and dormant assets, a comprehensive assessment of driving and restraining factors, and an assessment of opportunities and risks in the systemic lupus erythematosus clinical trial landscape. Systemic Lupus Erythematosus Overview Systemic lupus erythematosus (SLE) is a chronic autoimmune disease in which the immune system mistakenly attacks healthy tissues in various parts of the body. The exact cause of SLE is unknown, but it is believed to result from a combination of genetic, environmental, and hormonal factors. Common triggers include infections, sunlight exposure, and certain medications. Women, particularly of childbearing age, are more commonly affected. Symptoms of SLE vary widely and can affect many organ systems, leading to a wide range of clinical presentations. Common symptoms include fatigue, joint pain, skin rashes, photosensitivity, and fever. More severe cases can affect the kidneys, heart, lungs, and central nervous system, potentially leading to life-threatening complications. Diagnosis of SLE is based on a combination of clinical features and laboratory tests. The antinuclear antibody (ANA) test is a common initial screening tool, but additional tests like anti-double stranded DNA (anti-dsDNA) and anti-Smith antibodies, as well as assessments of kidney and liver function, are often necessary. Diagnosis can be challenging because SLE symptoms often mimic those of other diseases. Treatment for SLE focuses on managing symptoms and preventing flares. Mild cases may be treated with nonsteroidal anti-inflammatory drugs (NSAIDs) and antimalarial drugs like hydroxychloroquine. More severe cases may require corticosteroids, immunosuppressive drugs such as azathioprine, methotrexate, or newer biologics like belimumab. Lifestyle modifications, such as avoiding excessive sun exposure and managing stress, are also essential in controlling the disease. Find out more about systemic lupus erythematosus treatment drugs @ Drugs for Systemic Lupus Erythematosus Treatment A snapshot of the Systemic Lupus Erythematosus Pipeline Drugs mentioned in the report: Learn more about the emerging systemic lupus erythematosus pipeline therapies @ Systemic Lupus Erythematosus Clinical Trials Systemic Lupus Erythematosus Therapeutics Assessment The systemic lupus erythematosus pipeline report proffers an integral view of the systemic lupus erythematosus emerging novel therapies segmented by stage, product type, molecule type, mechanism of action, and route of administration. Scope of the Systemic Lupus Erythematosus Pipeline Report Coverage: Global Therapeutic Assessment By Product Type: Mono, Combination, Mono/Combination Therapeutic Assessment By Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III Therapeutics Assessment By Route of Administration: Intra-articular, Intraocular, Intrathecal, Intravenous, Ophthalmic, Oral, Parenteral, Subcutaneous, Topical, Transdermal Therapeutics Assessment By Molecule Type: Oligonucleotide, Peptide, Small molecule Therapeutics Assessment By Mechanism of Action: Antibody-dependent cell cytotoxicity, Cell death inhibitors, Cell death stimulants, Immunomodulators, CD40 ligand inhibitors, Sphingosine 1 phosphate receptor modulators, Calcineurin inhibitors, Immunosuppressants, Janus kinase 1 inhibitors, TYK2 kinase inhibitors, B cell activating factor inhibitors, Tumour necrosis factor ligand superfamily member 13 inhibitors Key Systemic Lupus Erythematosus Companies: Roche, ImmuPharma, UCB, Idorsia Pharmaceuticals, Biogen, AbbVie, Bristol-Myers Squibb, Vera Therapeutics, Beijing Mabworks Biotech Co., Ltd., BeiGene, Jiangsu Renocell Biotech Company, AstraZeneca, Pfizer, Red de Terapia Celular, Kira Pharmacenticals (US), LLC., Jemincare, Galapagos NV, Alumis, argenx, Gilead Sciences, Novartis, Zenas Biopharma, Horizon Therapeutics, Provention Bio, Janssen Research & Development, Eli Lilly and Company, Medsenic, Sanofi, Merck KGaA, Resolve Therapeutics, ILTOO, Janssen, Alpine Immune Sciences, Kezar Life Sciences, Neovacs, Kangpu Biopharmaceuticals, Cartesian Therapeutics, Apellis Pharmaceuticals, Inc., Alexion Pharmaceuticals, Inc., Q32 Bio Inc., Conduit Pharmaceuticals, Miltenyi Biomedicine GmbH, Kyverna Therapeutics, ImmPACT Bio, Genrix (Shanghai) Biopharmaceutical Co., Ltd., Gracell Biotechnologies (Shanghai) Co., Ltd., Cabaletta Bio, Tenet Medicines, Ascentage Pharma Group Inc., InnoCare, Eisai, Sorrento Therapeutics, Carna Bioscience, Yake Biotechnology, Equillium, Daiichi Sankyo Company, SinoMab Bioscience Ltd, Citryll BV, Sareum, Shanghai Junshi Biosciences, Chia Tai Tianqing Pharmaceutical Group Co., Ltd., Millennium Pharmaceuticals, Inc., Takeda, Synthekine, Hangzhou Sumgen Biotech Co., Ltd., Sana Biotechnology, Hoffmann-La Roche, Guangdong Ruishun Biotech Co., Ltd, Shanghai Ming Ju Biotechnology Co., Ltd., Autolus Limited, Nkarta, Inc., Luminary Therapeutics, Kyowa Kirin Co., Ltd., Shanghai Ming Ju Biotechnology, IGM Biosciences, Inc., GlaxoSmithKline, Fate Therapeutics, Cugene Inc., Century Therapeutics, Inc., Cullinan Therapeutics Inc., Juno Therapeutics, Inc., EdiGene Inc., Atara Biotherapeutics, Annexon, Inc., Adicet Therapeutics, Bioray Laboratories, PersonGen BioTherapeutics (Suzhou) Co., Ltd., Juventas Cell Therapy Ltd., Nanjing Bioheng Biotech Co., Ltd., Pregene ShenZhen Biotechnology, Artiva Bio, KeyMed Biosciences, IASO, JW Therapeutics, ROME Therapeutics, Ventus Therapeutics, Allosite Therapeutics, iCell Gene Therapeutics, Caribou Biosciences, LongBio Pharma, Amytrx Therapeutics, Corestem, Eliem Therapeutics, SinoMab Bioscience Ltd., and others. Key Systemic Lupus Erythematosus Pipeline Therapies: Obinutuzumab, Lupuzor (IPP-201101), Dapirolizumab pegol, Cenerimod, BIIB059, Upadacitinib, Deucravacitinib, Atacicept, MIL62, Zanubrutinib, RY_SW01 cell injection|Basic treatment, Ravulizumab, Rapcabtagene autoleucel, PF-06823859, Mesenchymal stem cells (MSC), KP104, JMKX000189, Iptacopan, GLPG3667|Placebo, ESK-001, Elsubrutinib, Efgartigimod alfa, Edecesertib, Ianalumab, Obexelimab (XmAb5871), Daxdilimab (VIB7734), PRV-3279, Nipocalimab, ABBV 599, NKTR-358 (LY3471851), Arscimed, SAR441344, Enpatoran, RSLV-132, Aldesleukin, Daratumumab, Branebrutinib, BMS-986256, ALPN-101, KZR-616, IFNα kinoid, KPG 818, Descartes-08, CFZ533, APL-2, ALXN2050, ADX-097, AZD1656, MB-CART19.1, KYV-101, IMPT-514, GR1603, GC012F Injection, CABA-201, Budoprutug, APG-2575, ICP-022, E6742, ALPN-303, AC0058, Mosunetuzumab, AS-0871, CD19/BCMA CAR T-cells, PF-06835375, EQ001 (Itolizumab), DS-7011a, SM03, CIT-013, SDC-1801, UBP1213, TQB3702, TAK-079, TAK-007, SYNCAR-001, SG301, SC291, RO7507062, RJMty19 (CD19-CAR-DNT cells), Relma-cel, PIT565, Obecabtagene autoleucel (obe-cel), NKX019, LMY-920, KK4277, JWCAR201, Imvotamab, GSK4527363, GSK4347859, FT819, CUG252, CNTY-101, CLN-978, CC-97540, Belantamab, ATHENA CAR-T ATA3219, ANX009, ADI-001, BRL-301, T-cell injection targeting CD19 chimeric antigen receptor, CNCT19, RD06-04, PRG-2311, PRG-1801, AlloNK, CM313, CT103A, JWCAR 029, Research program: endogenous reverse transcriptase inhibitors, VENT 03, ONT01, BCMA-CD19 cCAR T cells, CB-010, LP-005, AMTX 100, CE211AT15, TN-119, SN1011, QX002N, RSLV-145, Recombinant human plasma gelsolin, LN-008, TST 008, IBL 100s, and others. Dive deep into rich insights for new drugs for systemic lupus erythematosus treatment, visit @ Systemic Lupus Erythematosus Drugs Table of Contents For further information on the systemic lupus erythematosus pipeline therapeutics, reach out @ Systemic Lupus Erythematosus Treatment Drugs Related Reports Systemic Lupus Erythematosus Market Systemic Lupus Erythematosus Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, market share of the individual therapies, and key SLE companies including Biogen, Novartis, MorphoSys, Idorsia Pharmaceuticals, Viatris, RemeGen, UCB Pharma, Genentech, Bristol Myers Squibb, AbbVie, among others. Systemic Lupus Erythematosus Epidemiology Systemic Lupus Erythematosus Epidemiology Forecast – 2032 report delivers an in-depth understanding of the disease, historical, and forecasted SLE epidemiology in the 7MM. Lupus Nephritis Market Lupus Nephritis Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key lupus nephritis companies, including NOVARTIS, MORPHOSYS, ASTRAZENECA, ROCHE, KEZAR LIFE SCIENCES, ALEXION PHARMACEUTICALS, NOVARTIS, CABALETTA BIO, among others. Lupus Nephritis Pipeline Lupus Nephritis Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key lupus nephritis companies, including Inflection Biosciences, Equillium, Roche, Horizon Therapeutics, BeiGene, Janssen Research & Development, ImmPACT Bio, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. 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临床3期临床2期快速通道细胞疗法

100 项与 Cenerimod 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D11283	-	-	DB12705

研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
系统性红斑狼疮	临床3期	菲律宾	Idorsia Pharmaceuticals Ltd.	2022-12-13
系统性红斑狼疮	临床3期	保加利亚	Idorsia Pharmaceuticals Ltd.	2022-12-13
系统性红斑狼疮	临床3期	巴西	Idorsia Pharmaceuticals Ltd.	2022-12-13
系统性红斑狼疮	临床3期	中国台湾	Idorsia Pharmaceuticals Ltd.	2022-12-13
系统性红斑狼疮	临床3期	罗马尼亚	Idorsia Pharmaceuticals Ltd.	2022-12-13
系统性红斑狼疮	临床3期	希腊	Idorsia Pharmaceuticals Ltd.	2022-12-13
系统性红斑狼疮	临床3期	法国	Idorsia Pharmaceuticals Ltd.	2022-12-13
系统性红斑狼疮	临床3期	乌克兰	Idorsia Pharmaceuticals Ltd.	2022-12-13
系统性红斑狼疮	临床3期	美国	Idorsia Pharmaceuticals Ltd.	2022-12-13
系统性红斑狼疮	临床3期	阿根廷	Idorsia Pharmaceuticals Ltd.	2022-12-13

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临床结果

适应症

分期

评价

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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


NCT03742037 (CARE, EULAR2023)	临床2期	IFN-1 gene expression signature \| anti-dsDNA antibody levels	427	Cenerimod 4 mg	鹹憲廠膚簾築構膚構醖(鬱築構築糧衊衊壓顧憲) = 願餘鹽淵獵夢餘顧顧餘醖簾窪構醖鑰齋鑰憲醖 (壓鏇衊憲範積鹽鏇衊遞 ) 更多	积极	2023-05-31
				Placebo	鹹憲廠膚簾築構膚構醖(鬱築構築糧衊衊壓顧憲) = 製顧鹽範鏇顧範鏇壓鏇醖簾窪構醖鑰齋鑰憲醖 (壓鏇衊憲範積鹽鏇衊遞 ) 更多
NCT02472795 (CTgov)	临床1/2期	系统性红斑狼疮	105	Cenerimod (Cenerimod 0.5 mg (Part A))	願膚淵夢糧廠餘構齋遞(鏇餘積蓋蓋壓餘蓋構鹽) = 廠廠積醖積鏇願餘衊範蓋鑰壓餘築繭齋築夢糧 (遞鹽齋鬱衊淵鹽鹽壓蓋, 夢網鬱網衊襯鬱製網築 ~ 憲齋壓齋繭襯餘餘夢齋) 更多	-	2020-02-26
				Cenerimod (Cenerimod 1 mg (Part A))	願膚淵夢糧廠餘構齋遞(鏇餘積蓋蓋壓餘蓋構鹽) = 製繭鏇壓憲簾鏇膚襯鏇蓋鑰壓餘築繭齋築夢糧 (遞鹽齋鬱衊淵鹽鹽壓蓋, 糧醖膚繭製憲襯鏇糧製 ~ 齋鑰憲齋醖鹹衊願觸壓) 更多
NCT02472795 (Pubmed \| Lupus Sci Med)	临床1/2期	系统性红斑狼疮	105	Cenerimod 0.5 mg	(醖鑰膚廠夢選餘淵觸艱) = 醖壓窪蓋壓選獵淵蓋醖鹹憲餘齋艱遞壓築襯廠 (鹽獵範廠廠繭鹽襯鑰遞 )	积极	2019-01-01
				Cenerimod 1 mg	(醖鑰膚廠夢選餘淵觸艱) = 艱選構膚網夢獵觸夢鬱鹹憲餘齋艱遞壓築襯廠 (鹽獵範廠廠繭鹽襯鑰遞 )