A 2-Part Seamless Part A (Phase 2)/Part B (Phase 3) Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of BIIB059 in Participants With Active Subacute Cutaneous Lupus Erythematosus and/or Chronic Cutaneous Lupus Erythematosus With or Without Systemic Manifestations and Refractory and/or Intolerant to Antimalarial Therapy (AMETHYST)

开始日期2023-10-08

申办/合作机构

Biogen Idec Research Ltd.

100 项与 Litifilimab 相关的临床结果

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100 项与 Litifilimab 相关的转化医学

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100 项与 Litifilimab 相关的专利（医药）

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项与 Litifilimab 相关的文献（医药）

2024-07-01·The Journal of dermatology

An update on clinical trials for cutaneous lupus erythematosus

Review

作者: Stone, Caroline J. ; Faden, Daniella Forman ; Xie, Lillian ; Lopes Almeida Gomes, Lais ; Werth, Victoria P.

Abstract:

Cutaneous lupus erythematosus (CLE) comprises dermatologic manifestations that may occur independently or with systemic lupus erythematosus (SLE). Despite advancements in refining CLE classification, establishing precise subtype criteria remains challenging due to overlapping presentations and difficulty in distinguishing morphology. Current treatments encompass preventive measures, topical therapies, and systemic approaches. Hydroxychloroquine and glucocorticoids are the sole US Food and Drug Administration (FDA)‐approved medications for CLE, with numerous off‐label treatments available. However, these treatments are often not covered by insurance, imposing a significant financial burden on patients. The exclusion of most CLE patients, particularly those without concurrent SLE, from trials designed for SLE has resulted in a lack of targeted treatments for CLE. To develop effective CLE treatments, validated outcome measures for tracking patient responsiveness are essential. The Cutaneous Lupus Erythematosus Disease Area and Severity Index is widely utilized for its reliability, validity, and ability to differentiate between skin activity and damage. In contrast, the FDA mandates the use of the Investigator's Global Assessment, a five‐point Likert scale related to lesion characteristics, for skin‐related therapeutic trials. It requires the disease to resolve or almost completely resolve to demonstrate improvement, which can be difficult when there is residual erythema or incomplete clearance that is meaningfully improved from a patient perspective. Various classes of skin lupus medications target diverse pathways, allowing tailored treatment based on the patient's lupus inflammatory profile, resulting in improved outcomes. Promising targeted therapeutic drugs include anifrolumab (anti‐type 1 interferon), deucravacitinib (allosteric tyrosine kinase 2 inhibitor), litifilimab (plasmacytoid dendritic cell‐directed therapy), iberdomide (cereblon‐targeting ligand), and belimumab (B‐cell directed therapy). Despite the significant impact of CLE on quality of life, therapeutic options remain inadequate. While promising treatments for cutaneous lupus are emerging, it is crucial to underscore the urgency for skin‐focused treatment outcomes and the implementation of validated measures to assess therapeutic effectiveness in clinical trials.

2024-05-01·Current opinion in rheumatology

Emerging biologic therapies for systemic lupus erythematosus

Review

作者: Kato, Hiroshi ; Kahlenberg, J. Michelle

Purpose of review:

The approval of belimumab and anifrolumab has expanded the scope of treatment for systemic lupus erythematosus (SLE) patients. However, many patients remain refractory to currently available therapies and suffer from drug toxicities. This review will discuss approved and target-specific therapeutics in development that bring hope for better SLE treatments.

Recent findings:

Since the last review on this subject in the journal, the FDA has approved anifrolumab and belimumab for SLE and lupus nephritis (LN), respectively. A fully humanized anti-CD20, obinutuzumab, met the primary end point in a phase II trial in LN. A Tyk2 inhibitor, deucravacitinib, and an antibody targeting plasmacytoid dendritic cells, litifilimab, met the primary end point in phase II trials in SLE and cutaneous lupus erythematosus (CLE). Ustekinumab and baricitinib met the primary end point in phase II but not in phase III trials.

Summary:

While many drug candidates which met the end points in phase II trials have failed phase III trials, the number of target-specific therapies for SLE has continued to expand.

2024-01-01·Immunotherapy

The Development of Litifilimab (BIIB 059) for Cutaneous and Systemic Lupus Erythematosus

Review

作者: Furie, Richard ; Cho, Young Min

This review describes the litifilimab (BIIB 059) development program to date for systemic lupus erythematosus (SLE) and cutaneous lupus erythematosus (CLE). Plasmacytoid dendritic cells (pDCs), major producers of type I interferons (IFN-I), play a key role in SLE pathogenesis. Litifilimab, a humanized monoclonal antibody, binds to BDCA2, a protein uniquely expressed on pDCs. The consequence of BDCA2 ligation is the inhibition of IFN-I as well as IFN-III, cytokine and chemokine production. Phase I and II LILAC trial parts A and B achieved primary end points in SLE and CLE patients, confirming the importance of pDCs and IFN-I in SLE and CLE. Litifilimab is currently being evaluated in phase III trials in both SLE and CLE.

项与 Litifilimab 相关的新闻（医药）

2024-11-04

·PRNewswire

Lupus Research Alliance Announces Lupus Research Highlights at ACR Convergence 2024

Sixteen presentations of preclinical studies funded by the Lupus Research Alliance (LRA) to advance understanding of lupus and potential treatment pathways, including four oral presentations Two reports by Lupus Therapeutics, the clinical affiliate of the LRA, and the Lupus Clinical Investigators Network (LuCIN) on promoting equity in lupus clinical trials, and identifying trial barriers and solutions Fifteen industry-sponsored clinical research studies supported by Lupus Therapeutics and LuCIN, including positive results from the late-breaking Phase 3 dapirolizumab pegol trial NEW YORK, Nov. 4, 2024 /PRNewswire/ -- The Lupus Research Alliance (LRA), the largest private funder of lupus research worldwide, today announced that a total of 33 studies, funded by the organization or supported by its clinical research affiliate Lupus Therapeutics, will be presented at ACR Convergence 2024. The annual meeting of the American College of Rheumatology takes place November 14-19, at the Walter E. Washington Convention Center in Washington, D.C. The LRA, which seeks to accelerate the discovery and development of patient-centered treatments and diagnostics, pursues strategies to spur advancements from "bench to bedside." LRA-supported studies presented at ACR Convergence 2024 represent the full continuum of lupus research, from foundational research exploring new avenues of knowledge, to clinical trials evaluating potential new treatments. "ACR Convergence 2024 is met with pride and excitement by the Lupus Research Alliance and Lupus Therapeutics – pride in seeing the fruits of our funding and other initiatives to accelerate drug discovery and development, and excitement as we stand on the precipice of some important advancements," said LRA President and CEO Albert T. Roy. "There are more trials in mid-to-late-stage development than ever before, including dapirolizumab pegol in Phase 3 from UCB/Biogen, a Lupus Therapeutics partner. And we are gratified to witness the volume of CAR T cell therapy approaches in clinical development, having invested in 2014 in early research suggesting this approach as a promising intervention to explore for treating lupus," Roy added. Foundational Research Funded by the LRA Sixteen studies of LRA-funded research (four oral presentations and 12 posters) will be presented. Several focus on Childhood-Onset Systemic Lupus Erythematosus (cSLE), including: a detailed characterization of the disease; the effects of fatigue on pediatric patients' mental and physical health; and the discovery of Anti-Mitochondrial Antibodies (AMA), which are linked to higher disease activity. Other studies include: the development of a precision immunotherapy to target harmful B cells in Antiphospholipid Syndrome (APS) patients; the discovery of innate signaling pathways crucial in causing inflammation in lupus patients; and the epidemiology of strokes in children and adults with lupus. ORAL PRESENTATIONS Saturday, Nov. 16 Abstract #0837: Bispecific Autoantigen-T Cell Engagers (BaiTE) to Selectively Target Autoreactive B Cells in Antiphospholipid Syndrome 3:00-3:15 PM, Room 103AB Sunday, Nov. 17 Abstract #1702: Placental Developmental Defects in a Humanized-TLR8 Mouse Model of Spontaneous Anti-Phospholipid Antibody Induced Pregnancy Loss 3:15-3:30 PM , Room 103AB Monday, Nov. 18 Xist and XChromosome Inactivation in Female Biased Autoimmunity 9:00-9:30 AM, Room 145AB Abstract #2625: Brain Injury Markers Correlate with Impaired Executive Function and Disease Activity in Children with Systemic Lupus Erythematosus 3:30-3:45 PM, Room 202AB POSTERS Saturday, Nov. 16 Poster Session A, 10:30 AM-12:30 PM, Poster Hall: Abstract #0091: Targeting Endothelial Dysfunction in Lupus Nephritis: Effect of Sepiapterin, a Drug That Restores Endothelial Nitric Oxide Synthase Function, in a Murine Model of Lupus Nephritis Abstract #0098: Anti-HSP90α as a Protective Natural Antibody Against Secondary Antiphospholipid Syndrome in Systemic Lupus Erythematosus Sunday, Nov. 17 Poster Session B, 10:30 AM-12:30 PM , Poster Hall: Abstract #1266: Anti-Mitochondrial Antibodies Associate with Disease Activity and IFNα Expression in Childhood-onset Systemic Lupus Erythematosus Abstract #1273: An Investigation of Traumatic Events and Mental Health in cSLE Abstract #1274: Comparing Performance-Based Measures and Self-Reported Questionnaires for Assessment of Executive Function for Youth with Childhood-Onset Systemic Lupus Erythematosus Abstract #1278: The Effects of Fatigue on Self-Reported Mental and Physical Health in Childhood-Onset Systemic Lupus Erythematosus: A Cross-Sectional Study Abstract #1279: Cerebrovascular Accidents in Pediatric and Adult Systemic Lupus Erythematosus: A Comparison of Epidemiology and Outcomes Abstract #1280: Abnormal Cortical Gyrification Patterns in Adolescents with Childhood-onset SLE: Early Associations with Perceived Fatigue Abstract #1504: Novel Analytes Associated with Cognitive Impairment in Patients with Systemic Lupus Erythematosus: Serum S100A8/A9, MMP-9 and IL-6 Abstract #1506: Cognitive Impairment Prevalence and Most Affected Domains in Patients with SLE by the ACR Comprehensive Neuropsychological Battery Monday, Nov. 18 Poster Session C, 10:30 AM-12:30 PM, Poster Hall: Abstract #1788: Memory B Cell Activation and Dysregulation in Systemic Lupus Erythematosus Abstract #2380: Characterizing SLE Patients into Type 1 and Type 2 Disease States: Insights from a Single Lupus Cohort Research Conducted by Lupus Therapeutics and the Lupus Clinical Investigators Network (LuCIN) Lupus Therapeutics, the clinical affiliate of the Lupus Research Alliance, oversees the Lupus Clinical Investigators Network (LuCIN), consisting of 50+ premier, leading medical research institutions in North America, comprised of 200+ providers with expertise in lupus care and clinical trials. The following studies are based on annual surveys of LuCIN investigators and research teams on promoting equity in lupus clinical trials and identifying trial barriers and solutions. POSTERS Saturday, Nov. 16 Abstract 0180: Collaborative Solutions to Lupus Trial Challenges for Underrepresented Participant Recruitment & Engagement: Perspectives from the Lupus Clinical Investigators Network (LuCIN) Poster Session A, 10:30 AM-12:30 PM, Poster Hall Sunday, Nov. 17 Abstract #1039: Through the LuCIN Lens: Defining Barriers and Forging Solutions for Lupus Clinical Trials in North America Poster Session B, 10:30 AM-12:30 PM, Poster Hall Clinical Research Supported by Lupus Therapeutics and LuCIN The primary goal of Lupus Therapeutics and LuCIN is to accelerate and enhance the quality of lupus clinical trials through clinical expertise, advisory services, patient engagement and partnership/collaboration with biopharmaceutical companies and research partners. Lupus Therapeutics and LuCIN are involved in nearly 25% of active lupus clinical trials. Fifteen Lupus Therapeutics/LuCIN-supported programs and collaborations are being presented at ACR Convergence 2024: ORAL PRESENTATIONS Sunday, Nov. 17 Abstract #1773: Safety and Efficacy of CABA-201, a Fully Human, Autologous 4-1BB Anti-CD19 CAR T Cell Therapy in Patients with Immune-Mediated Necrotizing Myopathy and Systemic Lupus Erythematosus from the RESET-MyositisTM and RESET-SLETM Clinical Trials 3:30-3:45 PM, Room 145AB Monday, Nov. 18 Abstract #2577: Efficacy and Safety of ABBV-599 (Elsubrutinib and Upadacitinib Combination) and Upadacitinib Monotherapy for the Treatment of Systemic Lupus Erythematosus: Results Through 104 Weeks in a Long-Term Extension Study 1:30-1:45 PM, Room 146AB Abstract #2580: Safety and Efficacy of Subcutaneous Ianalumab (VAY736) for up to 68 Weeks in Patients with Systemic Lupus Erythematosus: Results from Phase 2 Study 2:15-2:30 PM Room 146AB Tuesday, Nov. 19 ***LATE-BREAKING ABSTRACT*** Abstract #L16: Dapirolizumab Pegol Demonstrated Significant Improvement in Systemic Lupus Erythematosus Disease Activity: Efficacy and Safety Results of a Phase 3 Trial 8:00-9:30 AM, 146AB POSTERS Saturday, Nov. 16 Poster Session A, 10:30 AM-12:30 PM, Poster Hall: Abstract #0087: SYNCAR: An Engineered IL-2/IL-2R-system That Selectively Enhances CD19 CAR T Cells to Deplete B Cells and Provide Therapeutic Benefit in SLE and RA Mouse Models Without Lymphodepletion Abstract #0324: Correlative Studies of CABA-201, a Fully Human, Autologous 4-1BB Anti-CD19 CAR T Cell Therapy in Patients with Immune-Mediated Necrotizing Myopathy and Systemic Lupus Erythematosus from the RESET-MyositisTM and RESET-SLETM Clinical Trials Abstract #0620: Clinical Efficacy and Patient-Reported Outcomes in Anti-Ro/Sjögren's Syndrome–Related Antigen a Antibody–Positive Patients with Active SLE Treated With Deucravacitinib in the Phase 2 PAISLEY Trial Abstract #0659: Obinutuzumab Benefits Patients with Active Lupus Nephritis Irrespective of Baseline Proteinuria Severity: A Post Hoc Analysis of a Phase II Trial Abstract #0662: Deucravacitinib, a First-in-Class, Oral, Selective, Allosteric Tyrosine Kinase 2 Inhibitor, in SLE: Efficacy by Baseline Demographics and Disease Characteristics in the Phase 2 PAISLEY Trial Abstract #0671: Effect of Litifilimab on Cutaneous Lupus Disease Area and Severity Index–Activity (CLASI-A) Subcomponents and Physician Global Assessment–Skin (PGA–Skin) in Patients with Cutaneous Lupus Erythematosus (CLE) in a Phase 2 Study Sunday, Nov. 17 Poster Session B, 10:30 AM-12:30 PM, Poster Hall: Abstract #1496: Dysregulated Serum Cytokines in Association with Clinical Manifestations in Patients with Systemic Lupus Erythematosus Abstract #1552: Kinetics of Mucocutaneous and Musculoskeletal Responses to Deucravacitinib in Patients with Active SLE in the Phase 2 PAISLEY Trial Abstract #1553: Safety, Pharmacokinetics, Clinical Efficacy and Exploratory Biomarker Results from a Randomized, Double-Blind, Placebo-Controlled Phase 1b Study of Enpatoran in Active Systemic and Cutaneous Lupus Erythematosus (SLE/CLE) Monday, Nov. 18 Poster Session C, 10:30 AM-12:30 PM, Poster Hall: Abstract #2425: Ianalumab Induced Durable Depletion of Circulating B Cell Subsets and Associated Changes in B Cell and Neutrophil Transcriptomic and Proteomic Profiles in Patients with Systemic Lupus Erythematosus: 52-Week Treatment Results from a Phase 2 Trial Abstract #2430: Dapirolizumab Pegol Impacts Important Immunologic Pathways in Systemic Lupus Erythematosus: Pharmacodynamic Analysis of T Cell and Antigen Presenting Cell Pathways from a Phase 2b Trial About Lupus Lupus is a chronic, complex autoimmune disease that affects millions of people worldwide. In lupus, the immune system, meant to defend against infections, produces autoantibodies that mistake the body's own cells as foreign, causing other immune cells to attack organs such as the kidneys, brain, heart, lungs and skin, as well as blood and joints. Ninety percent of people with lupus are women, most often diagnosed between the ages of 15-45. Black, Latinx, Indigenous, Asian and Pacific Islander people are disproportionately affected by lupus and more likely to experience severe lupus symptoms. About the Lupus Research Alliance The Lupus Research Alliance is the largest non-governmental, non-profit funder of lupus research worldwide. The organization aims to transform treatment by funding the most innovative lupus research, fostering diverse scientific talent, and driving discovery toward better diagnostics, improved treatments and ultimately a cure for lupus. Because the Lupus Research Alliance's Board of Directors funds all administrative and fundraising costs, 100% of all donations goes to support lupus research programs. For more information, please visit the LRA at LupusResearch.org and on social media at: X, Facebook, LinkedIn, and Instagram. About Lupus Therapeutics Lupus Therapeutics, the clinical research affiliate of the Lupus Research Alliance, aims to accelerate the development of curative treatments for all patients living with lupus. Lupus Therapeutics collaborates with premier research institutions, biopharmaceutical partners, and those living with lupus through the unprecedented Lupus Clinical Investigators Network (LuCIN) to drive rapid and meaningful progress in treatment development. The organization elevates the patient voice, engages community stakeholders, and strives for representation of the diverse lupus community in the clinical research process with the most innovative and renowned experts throughout North America. Visit LupusTherapeutics.org for more information. This information is brought to you by the Lupus Research Alliance and is not sponsored by, nor a part of, the American College of Rheumatology. SOURCE Lupus Research Alliance WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

临床2期临床结果临床3期免疫疗法

2024-11-02

·CPHI制药在线

葛蓝新通抗乙肝1类新药国内获批上市；华昊中天正式在港交所上市 | 制药在线一周药闻复盘

点击蓝字关注我们本周热点不少。首先看审评审批方面，有两个药值得关注，一个就是葛蓝新通抗乙肝1类新药国内获批上市，另一个就是诺华first-in-class药物Scemblix美国获批一线治疗Ph+慢性粒细胞白血病；其次看研发方面，不少药物取得新进展，例如，科伦博泰启动SKB264+奥希替尼vs.奥希替尼一线治疗NSCLCⅢ期临床等；再来看交易及投融资方面，热点事件不多，但是值得一提的是，GSK以8.5亿美金收购恩沐生物三特异抗体CMG1A46；最后是上市方面，华昊中天正式在港交所上市，核心产品优替德隆注射液已获批上市。本期盘点包括审评审批、研发、交易及投融资和上市四大板块，统计时间为10.28-11.1，包含27条信息。审评审批 NMPA 上市批准 1、10月28日，NMPA官网显示，新通药物全资子公司葛蓝新通制药1类新药甲磺酸普雷福韦片（曾用名：甲磺酸帕拉德福韦片）获批上市，用于治疗成人慢性乙型肝炎。普雷福韦基于肝靶向创新药物研发平台开发，在阿德福韦结构基础上引入芳基磷酸环二酯结构，形成肝靶向阿德福韦前药。 2、10月29日，NMPA官网显示，礼来的匹妥布替尼片（pirtobrutinib）获批上市，用于单药治疗既往接受过BTK抑制剂治疗的复发或难治性套细胞淋巴瘤（MCL）成人患者。匹妥布替尼是礼来研发的first-in-class 非共价BTK C481S抑制剂，作为全球首款非共价BTK抑制剂，将成为共价BTK抑制剂C481突变耐药患者的治疗新选择。 3、10月29日，NMPA官网显示，恒瑞医药的夫那奇珠单抗（Vunakizumab、SHR-1314）新适应症获批，推测此次适应症为强直性脊柱炎。夫那奇珠单抗是恒瑞医药自主研发的人源化IgG1抗IL-17A单抗，2024年8月，夫那奇珠单抗已获批上市，用于治疗斑块状银屑病。申请 4、10月28日，CDE官网显示，博锐生物的帕妥珠单抗生物类似药申报上市，这是第3款申报上市的帕妥珠单抗生物类似药，也是博锐生物第6款申报上市的生物类似药产品。原研为罗氏的帕妥珠单抗（商品名：Perjeta），属于一款HER2单抗，于2012年在美国获批上市，目前已在多个国家和地区获批3项适应症。截至目前，全球尚未有帕妥珠单抗生物类似药获批上市。 5、10月31日，CDE官网显示，科伦博泰的注射用芦康沙妥珠单抗第三项适应症申报上市，推测此次适应症为：用于经表皮生长因子受体酪氨酸激酶抑制剂（EGFR-TKI）治疗后进展的EGFR突变局部晚期或转移性非小细胞肺癌成人患者。芦康沙妥珠单抗是科伦博泰与默沙东（MSD）联合开发的一款靶向TROP-2的抗体偶联药物（ADC）。临床批准 6、10月29日，CDE官网显示，阿斯利康的AZD5492获批临床，拟用于治疗复发性或难治性B细胞恶性肿瘤。这是一款CD20×TCR×CD8三特异性抗体，是由CD8引导的T细胞衔接器剂。此次是这款候选新药首次在中国获批临床。 7、10月29日，CDE官网显示，三生国健1类新药重组抗BDCA2人源化单克隆抗体注射液获批两项临床，拟定适应症包括系统性红斑狼疮（SLE）、皮肤型红斑狼疮（CLE）。目前，全球只有少数几款以BDCA2为靶点的新药进入临床研究阶段，进展较快的产品为渤健（Biogen）开发的BIIB059，其正在全球Ⅲ期临床研究中评估治疗SLE和CLE的疗效和安全性。 8、10月29日，CDE官网，正大天晴1类新药TQB3909片获批两项临床，拟联合化疗用于急性淋巴细胞白血病（ALL）患者的治疗。TQB3909是一款BCL-2抑制剂，研究数据表明，TQB3909治疗R/R CLL/SLL患者总体缓解率（ORR）为88.9%，完全缓解/完全缓解伴不完全血液学恢复（CR/CRi）为44.4%；对BTK抑制剂耐药的R/R CLL/SLL患者的ORR为83.3%，CR/CRi为41.7%。 9、10月31日，CDE官网显示，强生的埃万妥单抗（amivantamab）皮下注射剂型两项新适应症获批临床，拟定适应症包括：联合FOLFIRI用于经系统治疗的RAS/RAF野生型、复发转移性结直肠癌；联合mFOLFOX6或FOLFIRI用于RAS/RAF野生型，左侧、不可切除或转移性结直肠癌。埃万妥单抗是一款靶向EGFR和MET的在研全人源化双特异性抗体，于2021年5月获FDA加速批准，此后陆续获批多项适应症，涵盖不同类型的非小细胞肺癌患者。 10、10月31日，CDE官网显示，艺妙神州全资子公司再妙生物1类新药ZM001注射液获批临床，拟开发治疗系统性红斑狼疮（SLE）。ZM001作为自体CAR-T细胞注射液，通过特异清除SLE患者体内的B细胞，是一种潜在的中度和重度SLE治疗药物。 11、11月1日，CDE官网显示，百时美施贵宝的nivolumab/relatlimab固定剂量复方注射液获批临床，拟用于肿瘤细胞PD-L1表达水平为1%-49%的复发性或转移性非鳞状非小细胞肺癌。这是一项LAG-3靶向疗法与PD-1抑制剂固定剂量组合疗法，此前已经获美国FDA批准治疗黑色素瘤。申请 12、10月30日，CDE官网显示，环码生物的HM2002注射液申报临床，HM2002注射液是一种环形RNA（circRNA）药物。临床前研究结果显示，在心肌梗死动物模型中，HM2002注射液能够促进血管再生，减少梗死和纤维化面积，显著改善心功能，有望为缺血性心脏病的治疗提供新的选择。 FDA 上市批准 13、10月28日，FDA官网显示，贝海生物的BH009（商品名：BEIZRAY）获批上市，主要用于乳腺癌、非小细胞肺癌、头颈部鳞癌、前列腺癌以及胃癌的治疗。BEIZRAY是通过临床验证并具有明显临床优势的多西他赛改良型新药。 14、10月29日，FDA官网显示，诺华的Asciminib/阿思尼布（商品名：Scemblix）新适应症获加速批准，用于一线治疗新诊断的慢性期费城染色体阳性慢性粒细胞白血病（Ph+ CML-CP）成人患者。Scemblix是首个通过特异性靶向ABL豆蔻酰基口袋发挥作用的STAMP抑制剂，2021年10月，Scemblix在美国获批上市，用于治疗接受过两种或多种TKI治疗或具有T315I突变的Ph+ CML-CP成人患者。申请 15、10月30日，FDA官网显示，第一三共和阿斯利康联合开发的德曲妥珠单抗(trastuzumab deruxtecan) 递交补充生物制品许可申请（sBLA），并被授予优先审评资格，用于转移阶段接受过至少一种内分泌治疗、不可切除或转移性、HER2低表达（IHC 1+或IHC 2+/ISH-）或HER2超低表达（IHC 0伴膜染色）乳腺癌成人患者。德曲妥珠单抗是一款采用独有技术设计的靶向HER2的DXd ADC，该药物由第一三共研制。快速通道资格 16、10月30日，FDA官网显示，东诚药业下属公司蓝纳成的177Lu-LNC1004注射液被授予快速通道资格，用于治疗接受过一种及以上酪氨酸激酶抑制剂的转移性碘-131难治性分化型甲状腺癌患者。177Lu-LNC1004注射液是一种靶向成纤维细胞活化蛋白（FAP）的放射性体内治疗药物。研发临床状态 17、10月28日，药物临床试验登记与信息公示平台显示，科伦博泰启动了一项SKB264（芦康沙妥珠单抗）的Ⅲ期临床（SKB264-Ⅲ-15），拟评估SKB264（4mg/kg、每2周1次）联合奥希替尼（40/80mg、每日1次）对比奥希替尼单药一线治疗携带EGFR突变的局部晚期或转移性非鳞状非小细胞肺癌（NSCLC）患者的疗效和安全性。 18、10月28日，clinicaltrials官网显示，礼来启动了Retatrutide对比替尔泊肽治疗肥胖的Ⅲ期临床（TRIUMPH-5）。Retatrutide是礼来基于GIP肽序开发的一款同时靶向GLP-1R、GCGR和GIPR的多肽药物，替尔泊肽是礼来开发的一款同时靶向GLP-1R和GIPR的多肽药物，于2022年5月在美国获批用于治疗2型糖尿病，并于2023年11月获批减重疗法。 19、10月30日，药物临床试验登记与信息公示平台显示，恒瑞医药已经启动了一项中国Ⅲ期临床研究，该研究旨在评价HRS-5965胶囊治疗阵发性睡眠性血红蛋白尿患者的有效性和安全性。HRS-5965为一款补体因子B抑制剂，这是该产品首次在中国启动Ⅲ期临床。 20、10月31日，药物临床试验登记与信息公示平台显示，博瑞医药的BGM0504启动了Ⅲ期临床试验。BGM0504是博瑞医药自主研发的GLP-1R/GIPR激动剂，于2023年1月进入临床开发阶段（定义为启动I期临床）。目前，BGM0504已完成一项降糖Ⅱ期研究和一项减重Ⅱ期研究，相关结果也已公布。 21、10月31日，药物临床试验登记与信息公示平台显示，翰森制药的HS-20094启动了Ⅲ期临床试验。HS-20094是翰森制药自主研发的GLP-1R/GIPR激动剂，于2021年11月进入临床开发阶段（定义为启动I期临床）。目前，HS-20094已完成一项降糖Ⅱ期研究，相关结果也已公布。临床数据 22、10月28日，康方生物公布了靶向IL-17的单克隆抗体古莫奇单抗（AK111）治疗中重度斑块型银屑病的关键3Ⅲ期研究（AK111-301）结果，继2023年达到主要终点后，已于近期完成研究并获得优异的长期疗效和安全性结果。古莫奇单抗单药治疗第52周时，PASI75应答率近100%，sPGA0/1应答率近90%，PASI90应答率超90%。 23、10月28日，康诺亚公布了1类新药司普奇拜单抗（研发代号：CM310）用于治疗成人中重度特应性皮炎的Ⅲ期临床研究52周疗效与安全性数据。52周数据进一步显示，司普奇拜单抗长期治疗可产生持续的疗效获益，并具有良好的安全性。司普奇拜单抗是一种针对白介素4受体α亚基(IL-4Rα)的高效、人源化单克隆抗体。 24、10月29日，礼来公布了Ⅲb期TRAILBLAZER-ALZ 6研究取得了积极结果。该研究显示，Donanemab（商品名：Kisunla）改良给药方案可降低渗出型淀粉样蛋白相关影像学异常（ARIA-E）的发生风险，且在淀粉样斑块和P-tau217减少方面，效果与标准给药方案相当。2024年7月，Donanemab是礼来研发的抗β淀粉样蛋白（Aβ）药物，于2024年7月获FDA批准上市，用于治疗阿尔茨海默病（AD）。 25、10月29日，再鼎医药公布了KarXT在中国用于精神分裂症治疗的Ⅲ期桥接研究的主要数据。与先前的全球临床研究一致，这项注册性桥接研究达到了其主要终点，在第五周时，与安慰剂相比，KarXT在阳性和阴性综合征量表（PANSS）总分上较基线具有9.2分的统计学意义上的显著降低。KarXT是一种口服M1/M4型毒蕈碱乙酰胆碱受体激动剂和毒蕈碱受体拮抗剂的组合。交易及投融资 26、10月29日，GSK宣布，以3亿美元的预付款从恩沐生物（Chimagen Biosciences）收购CMG1A46，这是一种处于临床阶段的CD19和CD20靶向T细胞接合器（TCE）。GSK计划开发和商业化CMG1A46用于B细胞驱动的自身免疫性疾病，如系统性红斑狼疮（SLE）和狼疮肾炎（LN）等。根据协议，GSK将提前支付3亿美元，以获得CMG1A46的全部全球权利。此外，恩沐生物将有资格获得相关的开发和商业化里程碑付款，总额为5.5亿美元。上市 27、10月31日，华昊中天正式在港交所上市，联席保荐人为建银国际和中信建投国际。华昊中天成立于2002年，是一家合成生物学技术驱动的生物医药公司，拥有一种核心产品及19种其他管线候选产品。核心产品优替德隆注射液已经于2021年在中国获批上市，用于治疗既往接受过至少一种蒽环类或紫杉类药物化疗方案的复发或转移性乳腺癌患者。 END 来源：CPHI制药在线声明：本文仅代表作者观点，并不代表制药在线立场。本网站内容仅出于传递更多信息之目的。如需转载，请务必注明文章来源和作者。投稿邮箱：Kelly.Xiao@imsinoexpo.com ▼更多制药资讯，请关注CPHI制药在线▼ 点击阅读原文，进入智药研习社~

上市批准生物类似药并购临床3期

2024-10-30

·EndPoints

Hints of impatience grow with Biogen as it tries to find a bridge to growth

Biogen’s investors are growing restless. Wednesday’s third-quarter earnings call checked most of the boxes for a successful report. The company raised its full-year guidance, and sales of its Alzheimer’s drug Leqembi (partnered with Eisai) continued to grow modestly. But in a sign investors may be getting antsy over CEO Chris Viehbacher’s strategy, the biotech faced multiple questions from analysts about whether its R&D pipeline can deliver the type of growth stockholders are seeking. Viehbacher acknowledged on the earnings call that Biogen is “in one of those classic situations in our industry” where a company attempts to bridge a dwindling legacy portfolio with a largely early-stage pipeline. He emphasized that Biogen isn’t content to just wait for all the readouts to come over the next few years, and reiterated that the company has $8 billion to $10 billion for potential acquisitions and partnerships through the end of 2025. But that can’t be just acquiring near-term sales, he said. “We’re not really interested in just buying revenue,” Viehbacher said. “If we can buy growth and we can make a very good return on investment, then we’ll do so. But as you know, assets get pretty highly priced as they get close to the market, so you have to do an awful lot of digging and an awful lot of looking, and that’s what we are doing.” Viehbacher was announced as Biogen’s CEO in November 2022, just a few weeks after the company announced its first Phase 3 data for Leqembi. He’ll celebrate his second anniversary next month, and over his time leading the company, the stock $BIIB has declined by almost 40%. Stifel analyst Paul Matteis highlighted the unease in the investment community, writing in a note Wednesday morning that the longer timelines for Alzheimer’s and the pipeline make Biogen “a contrarian stock.” But he said the “big picture” is still encouraging for the company. Turning things around will be no easy task. When Viehbacher took over, Biogen was reeling in the wake of a disastrous Alzheimer’s drug rollout in Aduhelm, corporate governance issues and a number of pipeline setbacks, as well as expiring patents and dwindling sales for its top-selling drug Tecfidera. During his two years, the CEO has preached patience and discipline by cutting costs, reorganizing top R&D posts and trimming the pipeline to make Biogen more agile and focused. On Wednesday’s call, however, one pipeline asset — the lupus program dapirolizumab pegol — drew particular skepticism. Evercore’s Umer Raffat asked why Biogen is highlighting the drug when most of the excitement in lupus is centered around CAR-T and CD19 approaches. Viehbacher likened the situation to when he was at GSK working on another lupus drug called Benlysta. GSK, he said, almost stopped developing that drug due to modest efficacy, but everything else in the space ended up failing. “We have to wait and see who actually gets to the finish line,” Viehbacher said. “On CAR-T, it’s some interesting data, but the logistics of CAR-T are not yet such that you’re going to be seeing significant numbers of patients being treated, in my personal opinion.” In addition to dapirolizumab pegol, Biogen highlighted its Alzheimer’s program BIIB080, another lupus candidate called litifilimab, and a recently acquired antibody known as felzartamab as potential revenue drivers. Execs said Wednesday that the combined peak revenue of these four assets is projected to reach $14 billion, though Viehbacher declined to break that figure down by program. Biogen shares fell as much as 3% in Wednesday trading, but rebounded slightly to about a 1.5% decrease.

并购高管变更临床3期

100 项与 Litifilimab 相关的药物交易

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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
皮肤红斑狼疮	临床3期	美国	Biogen, Inc.	2023-10-03
皮肤红斑狼疮	临床3期	阿根廷	Biogen, Inc.	2023-10-03
皮肤红斑狼疮	临床3期	巴西	Biogen, Inc.	2023-10-03
皮肤红斑狼疮	临床3期	保加利亚	Biogen, Inc.	2023-10-03
皮肤红斑狼疮	临床3期	加拿大	Biogen, Inc.	2023-10-03
皮肤红斑狼疮	临床3期	智利	Biogen, Inc.	2023-10-03
皮肤红斑狼疮	临床3期	法国	Biogen, Inc.	2023-10-03
皮肤红斑狼疮	临床3期	德国	Biogen, Inc.	2023-10-03
皮肤红斑狼疮	临床3期	匈牙利	Biogen, Inc.	2023-10-03
皮肤红斑狼疮	临床3期	意大利	Biogen, Inc.	2023-10-03

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临床结果

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分期

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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


NCT02847598 (LILAC \| LILAC study, CTgov)	临床2期	皮肤红斑狼疮 \| 系统性红斑狼疮	264	Placebo (Part A: Placebo)	壓構淵廠壓顧憲廠衊獵(夢膚廠壓鹹衊蓋鹽鬱淵) = 壓網壓糧積觸範範獵淵憲鹹襯繭衊鏇範齋顧淵 (糧膚構蓋簾獵壓廠壓窪, 衊鹽膚鹹醖壓淵淵選選 ~ 窪夢積蓋願鑰淵獵鑰艱) 更多	-	2023-05-15
				BIIB059 (litifilimab) (Part A: BIIB059 450 mg)	壓構淵廠壓顧憲廠衊獵(夢膚廠壓鹹衊蓋鹽鬱淵) = 衊鏇顧鏇範願壓鹹繭遞憲鹹襯繭衊鏇範齋顧淵 (糧膚構蓋簾獵壓廠壓窪, 鹽選鏇構蓋艱憲蓋築餘 ~ 糧餘範糧衊遞淵齋廠鬱) 更多
NCT02847598 (LILAC, Pubmed \| Br Dent J)	临床2期	系统性红斑狼疮	132	Litifilimab 450 mg	構膚簾糧鏇築製鏇鬱鬱(襯襯獵鹽積齋遞壓衊顧): P-Value = 0.04 更多	积极	2022-09-08
				Placebo
NCT02847598 (LILAC, Pubmed \| Br Dent J)	临床2期	皮肤红斑狼疮	132	Litifilimab 50 mg	廠積鹽網蓋網糧網壓鏇(鬱構糧艱鬱夢鹽選膚鹹) = Litifilimab was associated with one case of herpes zoster infection 觸鬱艱願獵壓築顧築夢 (膚製鑰遞簾獵鏇築壓鬱 ) 更多	积极	2022-07-28
				Litifilimab 150 mg
NCT02847598 (LILAC, EULAR2022)	临床2期	系统性红斑狼疮 anti-nuclear antibodies \| anti-double-stranded DNA antibodies	-	BIIB059 450 mg	餘憲淵選鏇廠選鏇齋獵(網選憲鹽鏇獵壓餘觸顧) = 餘願獵製網顧構廠築膚鏇願願艱窪願蓋選繭餘 (構衊構繭願觸築願築獵 ) 更多	积极	2022-06-01
				Placebo	餘憲淵選鏇廠選鏇齋獵(網選憲鹽鏇獵壓餘觸顧) = 艱網蓋壓廠繭淵製蓋壓鏇願願艱窪願蓋選繭餘 (構衊構繭願觸築願築獵 ) 更多
NCT02847598 (LILAC study, EULAR2022)	临床2期	皮肤红斑狼疮 BDCA2	-	BIIB059	顧鹽鹽廠廠鹽襯窪築壓(範衊願願衊糧製醖鹽製) = 憲築糧憲鹹鑰繭顧鏇壓壓膚構簾構衊範製廠鬱 (壓廠憲鏇願餘淵廠簾獵 ) 更多	积极	2022-06-01
NCT02847598 (LILAC, ACR2020) 人工标引	临床2期	系统性红斑狼疮	120	BIIB059	範鑰醖糧製淵簾艱願網(鹹膚選壓築觸餘膚築鑰) = 繭鏇築壓繭淵窪夢製窪鹽願窪齋衊淵鬱鑰簾淵 (築願夢遞齋憲構鹽窪醖, 1.2) 更多	积极	2020-11-07
				Placebo	範鑰醖糧製淵簾艱願網(鹹膚選壓築觸餘膚築鑰) = 齋襯築齋憲願觸獵襯獵鹽願窪齋衊淵鬱鑰簾淵 (築願夢遞齋憲構鹽窪醖, 1.3) 更多
LILAC (EULAR2020)	临床2期	皮肤红斑狼疮	132	BIIB059 50 mg	鹽鬱淵憲壓顧積淵鬱夢(鬱簾齋遞構衊觸構廠獵) = 62 (62.6%) 80 (60.6%) 廠顧膚膚網艱憲夢觸淵 (鑰齋製鹽鬱鬱廠廠積簾 ) 更多	积极	2020-06-03
				BIIB059 150 mg
NCT02847598 (Pubmed)	临床2期	系统性红斑狼疮	264	BIIB059	齋網積願糧壓衊壓顧鏇(構築獵蓋鬱餘艱蓋糧淵) = 淵憲夢艱蓋範遞範製窪衊蓋獵繭壓憲網獵鹹遞 (鹽艱淵糧範餘鬱膚艱積 ) 更多	-	2020-06-01
NCT02106897 (Pubmed \| J Clin Invest) 人工标引	临床1期	湿疹 \| 系统性红斑狼疮	54	BIIB059	網顧獵膚鹹選齋範網艱(獵築範膚蓋鹹繭窪襯鏇) = 獵餘鬱鹹憲醖選選餘簾膚淵顧廠壓顧憲選襯鹹 (鬱顧醖淵遞蓋簾構餘築 ) 更多	积极	2019-03-01
				Placebo	網顧獵膚鹹選齋範網艱(獵築範膚蓋鹹繭窪襯鏇) = 醖網齋糧獵蓋醖餘簾憲膚淵顧廠壓顧憲選襯鹹 (鬱顧醖淵遞蓋簾構餘築 ) 更多
NCT02106897 (EULAR2018)	临床1期	BDCA2 on pDC	-	BIIB059 20 mg/kg IV	膚糧廠範鬱齋艱蓋顧簾(醖範積鏇憲鬱醖觸襯範) = 餘構壓製衊憲觸壓選鑰窪積憲醖齋壓繭鑰鬱淵 (艱夢鏇襯繭艱範鑰築鑰 ) 更多	-	2018-06-13
				BIIB059 20, 50 or 150 mg SC	憲繭觸窪襯膚齋鹹壓醖(選艱願廠衊鑰築鹹膚膚) = 製膚獵壓鏇淵範膚膚簾鏇餘夢獵襯齋構齋鑰鑰 (繭壓範鑰網鹽鏇淵鹹網 ) 更多