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更新于：2025-04-21

Lutikizumab

更新于：2025-04-21

概要

概要

基本信息

药物类型

双特异性抗体

别名

Immunoglobulin, anti-(interleukin 1.beta./interleukin 1.alpha.) (synthetic human a-1234138 heavy chain), disulfide with synthetic human a-1234138 light chain, dimer、lutikizumab、A-1234138

+ [1]

靶点

IL-1α x IL-1β

作用方式

抑制剂

作用机制

IL-1α抑制剂(白细胞介素-1α抑制剂)、IL-1β抑制剂(白细胞介素-1β抑制剂)

治疗领域

感染皮肤和肌肉骨骼疾病其他疾病+ [4]

在研适应症

化脓性汗腺炎银屑病关节炎克罗恩病+ [3]

非在研适应症

膝关节炎

原研机构

AbbVie, Inc.

在研机构

AbbVie, Inc.

非在研机构-

最高研发阶段临床3期

首次获批日期-

最高研发阶段(中国)-

特殊审评-

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结构/序列

Sequence Code 9550995H

来源: *****

Sequence Code 9551004L

来源: *****

关联

项与 Lutikizumab 相关的临床试验

NCT06865105

/ Recruiting临床2期

A Phase 2 Multicenter, Randomized, Platform Study of Targeted Therapies for the Treatment of Adult Subjects With Active Psoriatic Arthritis

Psoriatic arthritis (PsA) is a type of arthritis that happens when the body's immune system attacks healthy cells and tissues causing joint pain, stiffness, and swelling. Symptoms can get worse and go away for periods of time. This study will evaluate the efficacy and safety of targeted therapies through a series of substudies, for the treatment of active psoriatic arthritis and to assess the changes in disease symptoms.
The therapies being assessed in this sub-study are risankizumab and lutikizumab. Participants will be randomized in a 1:1:1 ratio to one of the three treatment arms: lutikizumab monotherapy, risankizumab monotherapy or a combination therapy of lutikizumab and risankizumab. Around 120 participants will be enrolled in the study at approximately 40 sites worldwide.
There may be higher treatment burden for participants in this trial compared to their standard of care (due to study procedures). Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

开始日期2025-04-18

申办/合作机构

AbbVie, Inc.

NCT06718101

/ Recruiting临床2期

A Phase 2 Multicenter Platform Trial of Targeted Immunomodulator Therapies for Moderate to Severe Atopic Dermatitis

Atopic dermatitis (AD) is a skin condition that may cause a rash and itching due to inflammation of the skin. The purpose of this study is to evaluate the clinical efficacy and safety of single therapies and/or combination therapies for moderate to severe AD through multiple substudies.
This study will consist of multiple sub-studies, Sub-Study 1 will have a randomized, placebo controlled period 1 followed by a lutikizumab treatment period 2 enrolling 80 participants at a 1 to 1 ratio.
In Sub-Study 1, participants will receive subcutaneous (SC) injections of lutikizumab or matching placebo every other week for 16 weeks followed by an additional 32 weeks of subcutaneous (SC) injections of lutikizumab every other week for a total of 52 weeks.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic and may require frequent medical assessments, blood tests, and biomarker collections.

开始日期2024-12-19

申办/合作机构

AbbVie, Inc.

NCT06548542

/ Recruiting临床2期

A Phase 2a Multicenter, Randomized, Platform Study of Targeted Therapies for the Treatment of Adult Subjects With Moderate to Severe Crohn's Disease

Crohn's disease (CD) is a long-lasting disease that causes severe inflammation (redness, swelling), in the digestive tract, most frequently affecting the bowels. It can cause many different symptoms including belly pain, diarrhea, tiredness, and weight loss. Treatments are available but do not work the same for all patients or may stop working over time. This study will evaluate the effectiveness and adverse events of targeted therapies (TaTs) for adult participants with moderate to severe CD.
The medicines assessed in this study are risankizumab, ABBV-382 and lutikizumab. When participants join the study, they will be randomized into available study treatment groups. Adult participants with CD will be enrolled. Around 500 participants will be enrolled in the study at approximately 300 sites worldwide.
Risankizumab and ABBV-382 are given as an injection under the skin or as an infusion into the vein. Lutikizumab is given as an injection under the skin. Each group includes a 12-week induction period, a 12-week maintenance period, and an optional long-term extension period where medication will be given after the maintenance period.
There may be higher treatment burden for participants in this trial compared to their standard of care treatment without participating in this study. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, endoscopies, checking for side effects and completing questionnaires and a daily diary.

开始日期2024-09-04

申办/合作机构

AbbVie, Inc.

100 项与 Lutikizumab 相关的临床结果

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100 项与 Lutikizumab 相关的转化医学

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100 项与 Lutikizumab 相关的专利（医药）

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项与 Lutikizumab 相关的文献（医药）

2024-12-01·Orthopaedic Journal of Sports Medicine

Nonsurgical Knee Osteoarthritis Treatments for Reducing Inflammation as Measured on MRI Scans: A Systematic Review of Randomized Controlled Trials

Review

作者: Katz, Jeffrey N. ; Jones, Morgan H. ; Gottreich, Julia R.

Background::

Knee osteoarthritis (OA) is a debilitating condition, and synovitis is a structural marker of disease progression that can be identified on magnetic resonance imaging (MRI). Nonsurgical therapies have been developed with the goal of targeting this inflammation to reduce pain and slow disease progression.

Purpose::

To review current randomized controlled trials (RCTs) that measured changes in pain outcomes and synovitis on MRI scans after nonsurgical treatment for persons with knee OA.

Study Design::

Systematic review; Level of evidence, 1.

Methods::

The PubMed database was searched using the terms “knee osteoarthritis AND (synovitis OR inflammation)” for RCTs published between 2012 and 2022. Included were studies that collected both pain outcomes and quantitative measurements of synovitis on MRI scan before and after treatment; studies that investigated surgical treatments were excluded. We calculated standardized response means (SRMs) to analyze the effect sizes of treatment on pain and synovitis outcomes; SRMs were classified as having low responsiveness to treatment if <0.5, moderate responsiveness to treatment if between 0.5 and 0.8, and large responsiveness to treatment if >0.8.

Results::

Included in the review were 9 RCTs. Vitamin D and exercise therapy were the only 2 treatments that improved both pain and synovitis outcomes in comparison with their respective control groups. Statistically significant group differences in favor of treatment were seen in changes in pain after lutikizumab (anti-interleukin-1α/β dual variable domain immunoglobulin; SRM, 0.22; P = .050), allogenic human chondrocytes transduced with retroviral vector encoding transforming growth factor-β1 ( P = .0119 at 12 weeks, P = .120 at 52 weeks, and P = .0074 at 72 weeks), and Curcuma longa (turmeric; SRM, 0.35; P = .039 on the visual analog scale for pain and SRM, 0.47; P = .006 on the Western Ontario and McMaster Universities Osteoarthritis Index pain subscore). One study reported a statistically significant group difference in synovitis only after treatment with intra-articular methylprednisolone ( P = .01 at 14 weeks and P = .0006 at 26 weeks).

Conclusion::

Only vitamin D and exercise therapy were found to improve pain and synovitis after treatment in this review. Further research is needed to validate these findings and investigate alternative treatments for reducing pain and synovitis in persons with knee OA.

2024-03-01·Osteoarthritis and cartilage open

Does sex affect the efficacy of systemic pharmacological treatments of pain in knee osteoarthritis? A systematic review

Review

作者: Schnitzer, Thomas J ; Bagherzadeh, Leila ; Wafford, Q Eileen ; Espinosa-Salas, Santiago ; Witte, Graeme

Objective:

To determine whether sex influences the analgesic efficacy of systemic pharmacological treatment in patients with knee osteoarthritis.

Design:

A systematic review, guided by Cochrane methods, sourced studies from Medline, Cochrane Library, Embase, and CINAHL Plus with Full Text as of October 10, 2022. Eligible studies were double-blind RCTs evaluating systemic pharmacological treatments for knee osteoarthritis in adults, with minimum 30-day treatment duration, reporting sex-specific results or mentioning sex subgroup analysis for analgesic efficacy. The risk of bias was assessed using the Cochrane Risk of Bias tool version 2 (RoB 2).

Results:

9 studies (5201 participants) met inclusion criteria, analyzing drugs including duloxetine, etoricoxib, tapentadol, naproxcinod, lutikizumab, and rofecoxib. Only one study reported sex-specific results. Review findings suggested no significant sex-based differences in treatment efficacy, however, data were limited due to a lack of sex-specific reporting or inclusion of sex in subgroup analyses.

Conclusions:

Current evidence does not support the existence of sex differences in the analgesic efficacy of systemic knee osteoarthritis treatments. However, this conclusion is substantially limited by the paucity of sex-specific reporting of results or subgroup analyses in most primary studies, emphasizing the need for future research to report on sex-stratified data to allow for comprehensive, personalized treatment strategies.

2020-07-01·Annals of the rheumatic diseases

Can IL-1 be used as a target for osteoarthritis?

Letter

作者: Tian, Jian ; Zhang, Fangjie ; Cheng, Chao

We read with deep interest the article by Kloppenburg et al ,1 which was aimed at assessing the efficacy, safety, pharmacokinetics and pharmacodynamics of anti-interleukin (IL)-1α/β dual variable domain immunoglobulin lutikizumab (ABT-981) in erosive hand osteoarthritis (HOA). The results indicated that administration of 200 mg lutikizumab subcutaneously every 2 weeks for 24 weeks did not improve pain or imaging outcomes in erosive HOA compared with a placebo. This conclusion might be disappointing for doctors and even patients who desire a wider choice in drugs. In this study, the authors administered lutikizumab to neutralise the expression of IL-1α and IL-1β; however, to the best of our knowledge, until recently, the source …

项与 Lutikizumab 相关的新闻（医药）

2025-03-07

·Firstwordpharma

AAD25: UCB touts lasting benefit with Bimzelx in psoriasis, hidradenitis suppurativa

UCB's Bimzelx (bimekizumab-bkzx) is proving to be a key player in psoriasis and hidradenitis suppurativa (HS), with new longer-term data presented at the American Academy of Dermatology (AAD) conference Friday likely to give its commercial momentum a bit more spark.The dual IL-17A/F inhibitor's success has been driving major sales growth for the Belgian drugmaker, skyrocketing from $154 million in 2023 to $632 million last year, blowing past consensus (see – Spotlight On: UCB's Bimzelx delivers strong growth on back of US approvals). In a recent note, Morningstar analysts said Bimzelx was on track to hit blockbuster status and generate over €1 billion ($1.1 billion) in sales in 2025.'New standard' for successIn a new analysis from the second extension of the Phase III BE BRIGHT study, UCB said 67.7% of patients with moderate-to-severe plaque psoriasis maintained complete skin clearance (PASI 100) at the five-year mark. The analysis, which looked at 153 patients who completed the extension period, also showed that 84.9% achieved near-complete clearance (PASI 90) over that five-year span.Additionally, roughly 70% of patients at risk for developing psoriatic arthritis saw their skin completely clear up with Bimzelx treatment at three years, close to the 72% rate seen in the overall treated group. The drug's long-term safety profile also remained consistent with previous findings, with nasopharyngitis, oral candidiasis, and upper respiratory tract infections being the most common adverse events.Fiona du Monceau, head of patient evidence at UCB, said the company is aiming to set "a new standard for treatment success."Bimzelx was first approved in the US in 2023 for plaque psoriasis, and racked up three more indications — psoriatic arthritis, non-radiographic axial spondyloarthritis and ankylosing spondylitis — last September.It scored its fifth and most recent approval two months later, when the FDA greenlit the drug for HS based on results from the Phase III BE HEARD I and II studies. Two-year data from the extension trial presented at AAD showed sustained disease control with Bimzelx, as well as the potential to help prevent long-term structural damage caused by draining tunnels (DTs), which are painful "passageways" that can form under the skin that drain pus and blood.UCB said 55.7% of patients with baseline DTs were tunnel-free at two years of treatment. Even in patients with five or more DTs at baseline, 41.1% had none after two years of therapy. Treatment also provided meaningful relief from disease-associated skin pain, with 63.6% of patients reporting no or mild skin pain at two years compared to just 10% at baseline.According to Jefferies analysts, Bimzelx revenues could accelerate further in 2025 given the drug's differentiated profile versus competitors in psoriatic arthritis and HS. Following its approval in HS late last year, a FirstWord poll of 29 dermatologists found that over a third expected Bimzelx to become a frequently used treatment option that is used preferentially over other therapies (see – Physician Views Results: Many dermatologists keen to embrace Bimzelx for HS).Rival readoutsHowever, competition in the HS space is intensifying. In a recent note, Morgan Stanley analysts said "competitive developments could become increasingly in focus" with several late-stage candidates expected to report data. These include MoonLake's Immunotherapeutics' IL-17A/IL-17F nanobody sonelokimab, Incyte's oral JAK inhibitor povorcitinib, and AbbVie's IL-1A/ IL-1B antibody lutikizumab.Phase III data for sonelokimab and povorcitinib are due this half, while a readout for lutikizumab is expected in 2026. Meanwhile, Eli Lilly plans to reveal further Phase IIb results for a subcutaneous formulation of its CXCR1/2 monoclonal antibody eltrekibart this year. For more, see – Spotlight On: How emerging agents could reshape the HS treatment landscape.

临床结果临床3期上市批准免疫疗法临床2期

2025-02-06

·E药经理人

AZ超罗氏，礼来追赛诺菲，诺华掉出前五，全球制药营收TOP10洗牌

2025年全球制药TOP10已经重新洗牌：辉瑞重回第一，AZ超越常年霸榜前几名的罗氏，艾伯维成研发费用增速最高MNC。撰文| Erin 诚如此前预测，2025年全球制药TOP10的格局果然重新洗牌。辉瑞在万众瞩目中重回了制药业务营收第一的位置，其肿瘤业务收入更表现出进击肿瘤五霸的潜质。由于在第三季度就显露增长趋势，这并非最令人惊喜的消息。让人更加意想不到的是，AZ凭借21%的超高增长，在营收排名上超越了罗氏、诺华。不出意外，它也将一举挺进营收TOP5俱乐部，成为年度最大“黑马”。比“黑马”横空出世剧情更刺激的则是逆袭。谁能想到，过去10年时间，研发费用都在最后几名的艾伯维，其2024年竟然逆势增长66.66%到127.91亿美元，还一举冲进了MNC研发费用率（研发费用/总营收）TOP5的位置。数据来源：公司财报当然，也有让人惋惜者。罗氏、诺华两家排名下滑背后的研发投入难得回报的困境，GSK即将被新贵挤出前十的无奈…… 不过，无论是宇宙大药厂辉瑞重回制药业务第一，艾伯维跳出修美乐专利断崖困境实现逆袭，还是GSK增速不及无奈落榜，归根结底还是跨国药企的赚钱逻辑发生了变化：共同之处在于，单打独斗的速度已经难以赶上抱团取暖；独到之处则是，如今赚到的钱，来自何时的布局，是如何布局的？辉瑞重回第一，AZ超越罗氏、诺华成“黑马” 从目前发布2024年财报的跨国药企情况来看，全球制药巨头的格局已经发生了巨变。最大的两个变化是，辉瑞经历一年多的沉寂以及成本削减、裁员等调整后，再度重回制药业务营收第一；AZ的2024年业绩以21%的高增速，超越了罗氏、诺华两大营收TOP5常客，成为2025年最大“黑马”。其实从收入结构来看，辉瑞的调整成果显而易见，来自Seagen的ADC产品带来了收入增长新动能。值得一提的是，伴随Seagen新产品带来的数十亿美元收入，辉瑞的肿瘤业务在2024年全年收入超过150亿美元，几乎已经能冲击肿瘤“五霸”格局。当然，距离肿瘤产品总收入超过300亿美元的默沙东，以及超过220亿美元的AZ两大肿瘤巨头，辉瑞仍然有一些距离。 AZ能够取得21%的空前增长，成为2024年收入增速最高的跨国药企，探究其背后的原因，自然离不开产品的增长。从财报数字来看，AZ的肿瘤、心血管/肾脏/代谢疾病(CVRM)、呼吸与免疫(R&I)三大核心业务皆实现了超过20%的高速增长。除了大部分产品的增速为两位数之外，还有包括HER2 ADC Enhertu（德曲妥珠单抗）、AKT抑制剂Truqap、慢阻肺病三联复方Breztri、TSLP单抗Tezspire、同类首创红斑狼疮药物Saphnelo等新产品实现超过50%的增速。有意思的是，这些新产品几乎都带有FIC或是BIC的标签，也直接验证了AZ的BD与立项眼光。而AZ也在财报新闻稿中指出，2024年的收入高增长成为其“在2030年底实现800亿美元的总收入”目标的重要一步。不过，AZ的高速增长反衬出罗氏、诺华难以回避的业绩疲软困境。例如对于罗氏而言，肿瘤是其最核心的业务，2024年收入占比高达51.4%，然而增速却仅为7%。不过好消息是，罗氏的血液肿瘤仍然取得了79.09亿瑞士法郎（约为87.73亿美元），同比增长保持在两位数17.1%。此外，罗氏的眼科业务增速也高达44%，主要为VEGF-A/Ang2双抗产品Vabysmo（法瑞西单抗）所带来，该产品在2024年（上市的第三年）取得38.64亿瑞士法郎销售额。 Vabysmo也继承了罗氏以往“All in”一个疾病领域所有适应证的风格，被称为眼科王牌产品阿柏西普的“最强挑战者”，几乎包揽了视网膜疾病相关的所有核心适应证。在跨国药企的肿瘤、自免两大广阔赛道的竞争之外，全球疫苗市场的乏力也在跨国药企的业绩中体现出来。一方面，默沙东、辉瑞、阿斯利康三位TOP10成员的疫苗业务都呈现不同程度的下滑，其中辉瑞全球知名的肺炎疫苗Prevnar下滑1%；阿斯利康的疫苗和免疫疗法（V&I）业务核心产品几乎都在下滑，仅有用于婴儿预防和治疗呼吸道合胞病毒(RSV)感染的单抗Beyfortus呈现超200%的的增长，达7.22亿美元。默沙东的HPV疫苗Gardasil/Gardasil 9全年销售额为85.83亿美元，同比下降3%。甚至由于需求的下滑，默沙东在近期宣布了暂停向中国市场供应HPV疫苗。默沙东的中国市场收入，也遗憾得在HPV疫苗的负面影响下，下滑20%至53.94亿美元。同样面临增长乏力的还有GSK的带状孢疹疫苗，2024年销售额为33.64亿英镑，与上一年同期相比几乎没有增长。不过好在，GSK的肿瘤业务似乎为公司带来了新的增长动能，2024年收入14.1亿英镑，增速高达98%。这部分业务的增长主要来自于其PARP抑制剂 Zejula、PD-1单抗Jemperli、JAK1/JAK2抑制剂Ojjaara 和 ACVR1 抑制剂Omjjara等产品的增长。从业绩数字上来看，不出意外，GSK或将在今年无缘营收TOP10榜单。其总营收仅为313.76亿英镑（约为392.32亿美元），增速约为7%。推荐阅读 * 辉瑞再回第一？礼来跻身前十，GSK无奈落榜，全球制药营收TOP10格局生变 * 辉瑞“硬刚”肿瘤五霸，BMS大裁员，罗氏再砍管线，Q1营收TOP10药企仍在阵痛中… 默沙东研发费用下降40%后仍为第一；艾伯维开启逆袭如果对比2023年的情况来看，2024年更让人意外的一个现象是，艾伯维研发投入逆势增长，不仅相较于前一年增长66.66%到127.91亿美元，还一举冲进了营收TOP10 MNC中研发费用率（研发费用/总营收）TOP5的位置。增长半数的研发投入背后，其实是艾伯维广阔的研发管线布局。在自免领域，艾伯维的重磅白介素产品Skyrizi和JAK1抑制剂Rinvoq，接棒修美乐，成为收入支柱。2024年全年销售额分别达117.18亿美元和59.71亿美元，增长都超过50%。同时，艾伯维还在持续开发这两大产品的新潜力。据其披露的最新研发进展，Skyrizi还在开发针对银屑病关节炎、溃疡性结肠炎、炎症性肠病等多种新适应证；Rinvoq的潜力空间更是巨大，目前进行的III期临床就有4项，主要针对斑秃、遗传性球形红细胞增多症、系统性红斑狼疮等疾病。艾伯维在去年还在全球多地提交了Rinvoq用于治疗成人巨细胞动脉炎 (GCA) 的新适应证申请。从这点就可以看到，艾伯维能够在修美乐遭遇专利断崖后短时间内就恢复“元气”的秘籍就是，源源不断的新产品/新适应证接续。后续，艾伯维的自免双抗Lutikizumab、NLRX1激动剂ABBV-113、全新 IL-2突变蛋白产品CUG-252都在I、II期临床开发中，未来也将有望延续艾伯维在自免领域的强势地位。除此之外，艾伯维也仍然是一员BD猛将，2024年共计达成了16项BD/并购交易，除了自免之外，神经科学也是其重点关注的领域。 MNC中另一家BD“狂人”默沙东，尽管全年研发费用下滑了超40%，但其仍然是目前披露财报的MNC营收TOP10中，研发费用和研发费用率最高的公司之一。具体而言，默沙东全年投入了179.38亿美元进行研发，费用率高达31%。默沙东高昂的研发费用，其实主要为两大方向——拓展K药版图，寻找肿瘤领域下一个超级重磅炸弹。据悉，K药在2024年取得了294.82亿美元的销售额，增速高达18%，占据公司制药业务总营收的接近一半。E药经理人不完全统计，截至目前K药在全球获批了将近50个适应证，也就是说其上市10年，接近每年就能获批5个新适应证。而根据默沙东官网，以K药为核心的临床试验就高达10余项。此外，研发投入增长达到24%的阿斯利康，也坐稳了全球肿瘤五霸之一的地位，尤其是在ADC领域。据悉，上个月阿斯利康与第一三共合作的德曲妥珠单抗获批治疗HER2超低表达乳腺癌后，德曲妥珠单抗完成了HER2乳腺癌的全覆盖；也在同月，阿斯利康与第一三共合作的另一款TROP2靶向ADC Dato-DXd在FDA获批，阿斯利康再次在全球TROP2 ADC赛道占据了“C位”。相较于艾伯维、默沙东两位超高研发费用率，重回第一的宇宙大药厂辉瑞其实仍在突破研发回报难题的过程中。与其630多亿美元总收入相对应的却是仅108亿美元的研发费用，相对应的研发费用率也仅约为17.01%。值得一提的是，在本周辉瑞的财报电话会上，其宣布了计提29亿美元无形资产减值，其中就包括一款B7-H4 ADC的研发管线被砍掉。主要原因是，虽然取得了预期之内的早期临床数据，但未来并不具备超越标准疗法潜力。几乎在去年同期，辉瑞还砍掉了一款B7H4/CD3双抗，转而将资源更加集中在来自Seagen的ADC产品。除了辉瑞，面临专利悬崖带来的“青黄不接”困境的BMS，其2024年财报也暗示出探索“开源节流”的苦心。一方面，去年研发投入达111.59亿美元，同比增长20%；另一方面，BMS在今天财报发布的同时又宣布了新的成本削减计划——“计划在未来三年内额外节省 20 亿美元。”该计划包括了一部分裁员，还有营销、临床试验和供应链项目等运营成本的削减。一审| 黄佳二审| 李芳晨三审| 李静芝精彩推荐 CM10 | 集采 | 国谈 | 医保动态 | 药审 | 人才 | 薪资 | 榜单 | CAR-T | PD-1 | mRNA | 单抗 | 商业化 | 国际化｜猎药人系列专题 | 出海启思会 | 声音·责任 | 创百汇 | E药经理人理事会 | 微解药直播 | 大国新药 | 营销硬观点 | 投资人去哪儿 | 分析师看赛道 | 药事每周谈 | 医药界·E药经理人 | 中国医药手册创新100强榜单 | 恒瑞 | 中国生物制药 | 百济 | 石药 | 信达 | 君实 | 复宏汉霖｜翰森 | 康方生物 | 上海医药 | 和黄医药 | 东阳光药 | 荣昌 | 亚盛医药 | 齐鲁制药 | 康宁杰瑞 | 贝达药业 | 微芯生物 | 复星医药｜再鼎医药｜亚虹医药跨国药企50强榜单 | 辉瑞 | 艾伯维 | 诺华 | 强生 | 罗氏 | BMS | 默克 | 赛诺菲 | AZ | GSK | 武田 | 吉利德科学 | 礼来 | 安进 | 诺和诺德 | 拜耳 | 莫德纳 | BI | 晖致 | 再生元

财报抗体药物偶联物

2024-12-20

·药智网

艾伯维自免“守擂”

近日，艾伯维和Nimble Therapeutics宣布达成收购协议，根据协议，艾伯维将收购Nimble Therapeutics，包括其主要资产——一种用于治疗牛皮癣的临床前研究口服肽IL-23R抑制剂，以及一系列其他可能治疗多种自身免疫性疾病的新型口服候选肽药物管线。这是艾伯维在自免领域又一重磅BD，展示出自免王者艾伯维“守擂”的决心！ 01 王者“守擂” Nimble的临床前阶段IL23R抑制剂是一种用于治疗牛皮癣和炎症性肠病的研究性口服疗法。IL23R是某些自身免疫性疾病的临床验证的治疗靶点，也是银屑病和IBD发病和进展的主要促进因素，通过增加炎症和放大免疫反应，加重疾病发展。IL-23R抑制剂能够阻断IL-23与其受体的相互作用，抑制Th17炎症通路、细胞因子的产生和IL-23R的上调，进而减轻炎症。根据协议条款，艾伯维将在交易完成时支付2亿美元现金用于收购Nimble，同时提供一定的中期资金支持。此外，Nimble的股东在达成特定开发里程碑后，还将有机会获得额外的潜在付款。此次收购是艾伯维在战略布局上的重要举措，使其在自身免疫性疾病治疗领域的产品组合得到显著扩充。口服多肽类药物的加入，为其提供了更多样化的治疗选择，与现有药物形成互补，强化了在自身领域的市场地位。近年来，自免领域竞争激烈，艾伯维保持领先地位。根据艾伯维2024年前三季度财报，艾伯维前三季度在自免板块共营收193.88亿美元，稳居自免王座。艾伯维在自免领域拥有三款重磅产品，分别是Humira（阿达木单抗）、Skyrizi（利生奇珠单抗）和Rinvoq（乌帕替尼），2023年，艾伯维的3款自免产品均进入免疫赛道产品销量前十，艾伯维成为唯一一家3款免疫产品全部进入销量前十的企业。其中，阿达木单抗的市场份额由于专利到期受到仿制药的冲击，2024年Q3单季度收入进一步下滑至22.27亿美元（-37.2%）。然而，Skyrizi（利生奇珠单抗）和Rinvoq（乌帕替尼）正在以较高的增速填补Humira专利悬崖的收入缺口。Skyrizi第三季度销售32.05亿美元（+50.8%），预计2024年收入可超过110亿美元。Rinvoq第三季度销售16.14亿美元（+45.3%），预计全年收入将超50亿美元。近年来，艾伯维瞄准不同靶点，不断拓展研发管线，如GLP-2受体激动剂GLF065、RIPK抑制剂ABBV-668、ICOS/CD28双重抑制剂ALPN-101和IL-1α和IL-1β双变量结构域免疫球蛋白Lutikizumab等。图1 艾伯维自免领域管线图片来源：中信建投研报 Lutikizumab和ABBV-668均已进入II期临床，2024年1月，艾伯维公布了Lutikizumab治疗化脓性汗腺炎的II期临床优异数据，结果显示，Lutikizumab（300mg，每2周1次）组的患者中，达到HiSCR50（脓肿和炎性结节数量至少减少50%）的比例显著高于安慰剂组（59.5%vs.35%，P=0.027）。这表明Lutikizumab在治疗化脓性汗腺炎方面具有潜在的疗效。基于此，艾伯维进一步将Lutikizumab推进到3期临床；ABBV-668是艾伯维开发的苏氨酸蛋白激酶（RIPK）抑制剂，2期临床也有望在明后两年内完成。 02 持续发力近年来，艾伯维投入重金进行了大量的自免BD交易，据不完全统计，近年来艾伯维在自免领域license-in交易高达9笔，累计交易金额高达35亿美元。表1 艾伯维在自免领域license-in交易汇总数据来源：公开资料整理从交易时间来看，交易活动在三年内持续进行，表明艾伯维对自免领域的布局具有长期性和连贯性。值得一提的是，为了应对市场动态变化和自身发展需求，艾伯维在2024年战略布局步伐明显加快，自免领域交易数量高达7笔，其中一笔交易金额高达17.1亿美元，并且几乎都是潜在的FIC药物。此外，这些交易覆盖研发全周期与多种疾病，涉及的项目涵盖了从临床前研究到II期临床阶段的不同药物，包括IL-23、TL1A、NLRX1等多种不同新兴靶点，同时针对多种自身免疫性疾病，包括常见的银屑病、类风湿关节炎、克罗恩病、溃疡性结肠炎等，充分体现了艾伯维全方面布局的战略。值得一提的是，艾伯维对IBD领域格外看重。仅2024年，艾伯维就已五度在IBD领域“发力”： 2024年3月20日，艾伯维和Parvus Therapeutics达成全球独家选择权协议，艾伯维将利用Parvus的NavacimTM Treg免疫耐受平台开发和商业化IBD的新疗法。 2024年3月25日，艾伯维和Landos Biopharma签订收购协议，艾伯维获得潜在“first-in-class”口服NLRX1激动剂NX-13全球独家许可权，NLRX1在调控免疫代谢和炎症过程中起着关键作用，其激活可以影响IBD发生的多个机制。 2024年6月13日，艾伯维与明济生物制药（北京）有限公司达成开发FG-M701的许可协议。FG-M701是一种用于治疗IBD的下一代TL1A抗体，目前正处于临床前开发阶段。 2024年6月27日，艾伯维与Celsius Therapeutics达成收购协议，获得其潜在FIC产品CEL383，用于治疗IBD。 2024年12月13日，艾伯维与Nimble Therapeutics达成收购协议，获得其处于临床前阶段的在研口服疗法口服肽类IL-23受体（IL-23R）抑制剂，用于治疗银屑病和IBD。通过一系列的license-in交易和收购，艾伯维不断扩大其在自免市场的覆盖范围，使其在竞争激烈的自免领域保持领先地位。 03 结语凭借“冠军”产品的支撑以及“种子”产品的蓄势待发，艾伯维“自免王者”地位不证自明。参考资料 [1]https://news.abbvie.com/2024-12-13-AbbVie-to-Acquire-Nimble-Therapeutics,-Further-Strengthening-Immunology-Pipeline [2]https://news.abbvie.com/2024-01-08-Lutikizumab-Showed-Positive-Results-in-a-Phase-2-Trial-of-Adults-with-Moderate-to-Severe-Hidradenitis-Suppurativa-as-Program-Advances-to-Phase-3 [3]艾伯维官网、Nimble Therapeutics官网、中信建投研报、公开资料等友情推荐：医药行业深度技术内容，点击“博药”查看详情~ 声明：本内容仅用作医药行业信息传播，为作者独立观点，不代表药智网立场。如需转载，请务必注明文章作者和来源。对本文有异议或投诉，请联系maxuelian@yaozh.com。责任编辑 | 史蒂文合作、投稿、转载开白 | 马老师 18323856316（同微信）阅读原文，是受欢迎的文章哦

财报并购临床3期

100 项与 Lutikizumab 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	-	DB16224

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
化脓性汗腺炎	临床3期	美国	AbbVie, Inc.	2024-06-27
化脓性汗腺炎	临床3期	日本	AbbVie, Inc.	2024-06-27
化脓性汗腺炎	临床3期	澳大利亚	AbbVie, Inc.	2024-06-27
化脓性汗腺炎	临床3期	奥地利	AbbVie, Inc.	2024-06-27
化脓性汗腺炎	临床3期	比利时	AbbVie, Inc.	2024-06-27
化脓性汗腺炎	临床3期	保加利亚	AbbVie, Inc.	2024-06-27
化脓性汗腺炎	临床3期	加拿大	AbbVie, Inc.	2024-06-27
化脓性汗腺炎	临床3期	克罗地亚	AbbVie, Inc.	2024-06-27
化脓性汗腺炎	临床3期	捷克	AbbVie, Inc.	2024-06-27
化脓性汗腺炎	临床3期	丹麦	AbbVie, Inc.	2024-06-27

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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


NCT05139602 (Biospace) 人工标引	临床2期	化脓性汗腺炎	153	lutikizumab	鬱網齋鹽糧壓憲網糧鏇(遞顧淵廠製壓鹹願遞襯) = 選繭憲衊選衊築製繭願獵膚餘淵願淵繭顧遞簾 (齋選襯鏇齋構醖艱廠鬱 ) 更多	积极	2024-01-08
				placebo	簾獵醖襯夢壓壓窪齋積(淵製繭網鹹糧壓繭願鬱) = 築窪獵艱壓選壓夢壓積網艱窪鬱廠衊衊糧艱鹹 (襯製願蓋醖觸蓋糧鑰築 ) 更多
NCT02087904 (CTgov)	临床2期	膝关节炎	350	Placebo	膚構選膚憲餘蓋醖積觸(鑰製鏇餘壓糧鏇淵選鏇) = 積壓範遞獵鏇淵選範憲構願築膚齋鹽遞蓋醖選 (鑰願鬱鏇夢蓋艱醖醖鏇, 築衊鏇壓製齋築簾鏇網 ~ 觸選憲艱獵鹽齋鑰遞選) 更多	-	2019-08-28
NCT01668511 (Pubmed \| Osteoarthritis Cartilage)	临床1期	膝关节炎	36	ABT-981 0.3 mg/kg	選鏇醖衊艱遞觸衊範餘(網廠繭鑰艱觸鬱鑰顧壓) = 齋選憲網窪製製繭遞構壓淵顧鑰襯艱鹽觸醖蓋 (憲鏇憲築鏇積選獵顧顧 ) 更多	-	2017-12-01
				ABT-981 1 mg/kg	選鏇醖衊艱遞觸衊範餘(網廠繭鑰艱觸鬱鑰顧壓) = 廠繭廠觸願蓋鏇鏇遞壓壓淵顧鑰襯艱鹽觸醖蓋 (憲鏇憲築鏇積選獵顧顧 ) 更多
NCT02384538 (CTgov)	临床2期	骨关节炎	132	Placebo for ABT-981 (Placebo)	鹹壓網鏇糧遞壓鏇廠觸(選簾襯鹹繭夢醖醖鑰餘) = 衊壓選遞鹽蓋製繭憲鏇鏇築膚壓顧願簾築醖膚 (艱醖鏇艱衊憲遞襯膚積, 廠醖鹽窪簾選壓窪餘壓 ~ 築繭願餘簾艱鏇醖網醖) 更多	-	2017-07-13
				ABT-981 (ABT-981)	鹹壓網鏇糧遞壓鏇廠觸(選簾襯鹹繭夢醖醖鑰餘) = 網觸糧醖衊艱壓糧艱齋鏇築膚壓顧願簾築醖膚 (艱醖鏇艱衊憲遞襯膚積, 築齋憲選鑰簾願衊遞衊 ~ 構糧築製製糧鹹願鹹選) 更多
EULAR2014	N/A	膝关节炎 hsCRP \| VEGF \| C1M ... 更多	36	ABT-981 0.3 mg/kg	獵鑰醖選醖餘壓顧壓鬱(糧衊製獵積鑰選鑰構壓) = nonsignificant decreasing trend in the 1 and 3 mg/kg groups 鹽淵範餘積製淵鬱餘觸 (壓獵壓製獵糧獵齋簾製 ) 更多	积极	2014-06-11
				ABT-981 1 mg/kg
EULAR2014	临床1期	骨关节炎	-	ABT-981	鑰齋遞鹽廠鹽鹽艱網鑰(顧糧網築願窪壓憲糧選) = Measurable ADA titers were detected in 7 subjects on active treatment 壓淵淵餘醖糧範鏇遞壓 (齋遞鹽網選範觸範蓋鹹 ) 更多	-	2014-06-11