Izokibep(Izokibep) - 药物靶点：IL-17A x albumin_在研适应症：化脓性汗腺炎，斑块状银屑病，银屑病关节炎_专利_临床

概要

基本信息

药物类型

融合蛋白

别名

ABY 035、ABY-035/AFO2、AFB-035

+ [3]

靶点

IL-17A x albumin

作用机制

IL-17A抑制剂(白细胞介素-17A抑制剂)、albumin调节剂(血清白蛋白调节剂)

治疗领域

免疫系统疾病感染皮肤和肌肉骨骼疾病+ [2]

在研适应症

化脓性汗腺炎斑块状银屑病银屑病关节炎+ [3]

非在研适应症

AS大动脉炎

原研机构

Affibody AB

在研机构

ACELYRIN, Inc.Inmagene Biopharmaceuticals Ltd.

Affibody AB

+ [2]

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)临床3期

特殊审评-

序列信息

Sequence Code 1191632853

来源: *****

关联

15

项与 Izokibep 相关的临床试验

NCT05905783 / Active, not recruiting临床3期

A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 3 Study to Evaluate the Efficacy and Safety of Izokibep in Subjects With Moderate to Severe Hidradenitis Suppurativa

Izokibep is a small protein molecule that acts as a selective, potent inhibitor of interleukin 17A, to which it binds with high affinity. This study investigates izokibep in participants with active Hidradenitis Suppurativa (HS), including tumor necrosis factor-alpha inhibitor (TNFi) naïve participants, and those who had an inadequate response or intolerance to TNFi, or for whom TNFi is contraindicated.

开始日期2023-06-22

申办/合作机构

ACELYRIN, Inc.

CTIS2022-501362-22-00 / Not yet recruiting

22104: A Randomized, Double-blind, Placebo-controlled, Multicenter Phase 2b/3 Study to Evaluate the Efficacy and Safety of Izokibep in Subjects with Active Psoriatic Arthritis - 22104

开始日期2023-04-25

申办/合作机构

ACELYRIN, Inc.

NCT05623345 / Active, not recruiting临床2/3期

A Randomized, Double-blind, Placebo-controlled, Multicenter Phase 2b/3 Study to Evaluate the Efficacy and Safety of Izokibep in Subjects With Active Psoriatic Arthritis

Izokibep is a potent and selective inhibitor of interleukin (IL)-17A that is being developed for treatment of psoriatic arthritis (PsA).
This study will evaluate the efficacy of izokibep in subjects with PsA.

开始日期2022-11-21

申办/合作机构

ACELYRIN, Inc.

100 项与 Izokibep 相关的临床结果

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100 项与 Izokibep 相关的转化医学

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100 项与 Izokibep 相关的专利（医药）

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5

项与 Izokibep 相关的文献（医药）

2023-12-31·mAbs

Izokibep: Preclinical development and first-in-human study of a novel IL-17A neutralizing Affibody molecule in patients with plaque psoriasis

Article

作者: Gunneriusson, Elin ; Gudmundsdotter, Lindvi ; Klint, Susanne ; Kamboj, Amol P. ; Wennborg, Anders ; Bejker, David ; Frejd, Fredrik Y. ; Höidén Guthenberg, Ingmarie ; Feldwisch, Joachim ; Dillner Bergstedt, Karin ; Nyborg, Andrew C. ; Peloso, Paul M.

Psoriasis, an immune-mediated inflammatory disease, affects nearly 125 million people globally. The interleukin (IL)-17A homodimer is a key driver of psoriasis and other autoimmune diseases, including psoriatic arthritis, axial spondyloarthritis, hidradenitis suppurativa, and uveitis. Treatment with monoclonal antibodies (mAbs) against IL-17A provides an improvement in the Psoriasis Area and Severity Index compared to conventional systemic agents. In this study, the Affibody^Ⓡ technology was used to identify and optimize a novel, small, biological molecule comprising three triple helical affinity domains, izokibep (previously ABY-035), for the inhibition of IL-17A signaling. Preclinical studies show that izokibep, a small 18.6 kDa IL-17 ligand trap comprising two IL-17A-specific Affibody domains and one albumin-binding domain, selectively inhibits human IL-17A in vitro and in vivo with superior potency and efficacy relative to anti-IL-17A mAbs. A Phase 1 first-in-human study was conducted to establish the safety, pharmacokinetics, and preliminary efficacy of izokibep, when administered intravenously and subcutaneously as single doses to healthy subjects, and as single intravenous and multiple subcutaneous doses to patients with psoriasis (NCT02690142; EudraCT No: 2015-004531-13). Izokibep was well tolerated with no meaningful safety concerns identified in healthy volunteers and patients with psoriasis. Rapid efficacy was seen in all psoriasis patients after one dose which further improved in patients receiving multiple doses. A therapeutic decrease in joint pain was also observed in a single patient with concurrent psoriatic arthritis. The study suggests that izokibep has the potential to safely treat IL17A-associated diseases such as psoriasis, psoriatic arthritis, axial spondyloarthritis, hidradenitis suppurativa, and uveitis.

2023-09-15·The British journal of dermatology

Clinical trial results for treatment of psoriasis with izokibep.

Article

2023-09-15·The British journal of dermatology

Izokibep for the treatment of moderate-to-severe plaque psoriasis: a phase II, randomized, placebo-controlled, double-blind, dose-finding multicentre study including long-term treatment

Article

作者: Niesmann, Johannes ; Feldwisch, Joachim ; da Mota, Rodrigo ; Weirich, Oliver ; Osterling Koskinen, Lisa ; Frejd, Fredrik Y ; Ardabili, Michael ; Brun, Nikolai C ; Rothhaar, Alex ; Ohlman, Sven ; Peloso, Paul M ; Gerdes, Sascha ; Staubach, Petra ; Vlasitz, Gerda ; Wetzel, Dieter ; Dirschka, Thomas

Abstract:

Background:

Monoclonal antibodies to interleukin (IL)-17 have shown strong efficacy in patients with psoriasis. Izokibep is a unique IL-17A inhibitor with a small molecular size and favourable distribution to sites of inflammation.

Objectives:

To evaluate the dose response, efficacy and safety of izokibep in patients with plaque psoriasis.

Methods:

In this double-blind, randomized, phase II dose-finding study (AFFIRM-35) in adults with moderate-to-severe plaque psoriasis and inadequate response to two or more standard therapies, patients were randomized (1:1:1:1:1) to placebo or izokibep 2, 20, 80 or 160 mg every 2 weeks for 12 weeks. During the remainder of the 52-week core study, patients given placebo were switched to izokibep 80 mg, and dosing intervals were adapted based on Psoriasis Area and Severity Index (PASI) scores for all patients. The core study was followed by two optional consecutive 1-year extension periods for a total duration of 3 years. The primary endpoint was a 90% reduction in PASI score (PASI 90) at week 12. Additional efficacy outcomes and adverse event (AE) rates were evaluated.

Results:

In total, 109 patients were randomized [safety set, n = 108 (one exclusion criteria failure); full analysis set, n = 106]. At week 12, PASI 90 response rates were 0%, 5%, 19%, 71% and 59% for the placebo, 2-, 20-, 80- and 160-mg izokibep groups, respectively. Rapid dose-dependent improvements were also observed across other efficacy outcomes. During the placebo-controlled period, AEs in the izokibep groups were similar to placebo except for mild injection site reactions. AEs were generally mild to moderate and the drug was well tolerated. Izokibep maintained efficacy at the higher dosage groups for up to 3 years, with no new safety signals.

Conclusions:

Data from this phase II study indicate that izokibep is well tolerated and efficacious in the treatment of plaque psoriasis. Higher doses or more frequent dosing could be explored to further enhance response rates.

135

项与 Izokibep 相关的新闻（医药）

2024-09-21

·GlobeNewswire-Health Care

ACELYRIN, INC. Announces Positive Results from Global Phase 3 Clinical Trial of Izokibep in Hidradenitis Suppurativa to be Highlighted in Late-Breaking Oral Presentation at EADV 2024

Sept. 19, 2024 -- ACELYRIN, INC. (Nasdaq: SLRN), a late-stage clinical biopharma company focused on accelerating the development and delivery of transformative medicines in immunology, today announced that positive results from the company’s global Phase 3 clinical trial of izokibep in moderate-to-severe hidradenitis suppurativa (HS) patients will be shared as a late-breaking oral presentation at the 2024 European Academy of Dermatology and Venereology taking place September 25-28, 2024 in Amsterdam, Netherlands. Presentation details are as follows: Title: Efficacy and Safety of Izokibep, a Novel IL-17A Inhibitor, in Moderate-to-Severe Hidradenitis Suppurativa: Week 12 Results from a Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase 3 Study Session Type: Late-breaking Oral Presentation Abstract ID: 7995 Date/Time: Wednesday, September 25, 2024; 4:00 – 4:15PM CEST Presenter: Kim Papp, M.D., Ph.D., President and Director of Research, Probity Medical Research, Inc. “The global Phase 3 clinical trial of izokibep as a treatment for HS demonstrated statistically signiﬁcant and clinically meaningful responses across multiple eﬃcacy endpoints – particularly in higher order responses such as HiSCR90 and HiSCR100 – by 12 weeks,” said Shephard (Shep) Mpofu, M.D., Chief Medical Officer of ACELYRIN. “We believe these data could support a path to regulatory approval in this indication and look forward to having the data presented in this important dermatology forum.” Izokibep is a small protein therapeutic designed to inhibit IL-17A with high potency through tight binding aﬃnity, the potential for robust tissue penetration due to its small molecular size – about one-tenth the size of a monoclonal antibody – and an albumin binding domain that extends half-life. It is currently being evaluated in multiple late-stage trials in moderate-to-severe Hidradenitis Suppurativa (HS), moderate-to-severe psoriatic arthritis (PsA), and noninfectious uveitis. Phase 3 HS and PsA data presented to date have demonstrated levels of clinical response comparable with next generation approaches to IL-17 inhibition. ACELYRIN previously announced that it would discontinue internal development of izokibep in HS and PsA. ACELYRIN, INC. (Nasdaq: SLRN) is focused on providing patients life-changing new treatment options by identifying, acquiring, and accelerating the development and commercialization of transformative medicines. ACELYRIN’s lead program, lonigutamab, is a subcutaneously delivered monoclonal antibody targeting IGF-1R being investigated for the treatment of thyroid eye disease. The content above comes from the network. if any infringement, please contact us to modify.

临床结果

2024-08-27

·PMLiVE

Acelyrin shares positive phase 3 results for izokibep in hidradenitis suppurativa

Acelyrin has shared positive results from a late-stage study of its IL-17A inhibitor izokibep in hidradenitis suppurativa (HS), but has said it will not be moving forward with the asset in this indication. Estimated to affect about 1% of the population in most studied countries, HS is a chronic inflammatory skin condition that causes painful nodules and abscesses. In the phase 3 trial, izokibep demonstrated statistically significant responses across multiple efficacy endpoints at week 12, with 33% of patients being treated with izokibep 160mg weekly achieving at least a 75% reduction in total abscess and inflammatory nodule count (HiSCR75) compared to 21% of those receiving placebo. Results also showed that 25% and 22% of izokibep-treated patients achieved HiSCR90 and HiSCR100, respectively, compared to 9% and 8% in the placebo cohort. The announcement comes shortly after the drug demonstrated promising results in a phase 2b/3 study for psoriatic arthritis (PsA), a chronic inflammatory disease characterised by joint pain, stiffness and swelling. Acelyrin said it will complete the ongoing HS and PsA trials, but will suspend new investment in these indications. A phase 2b/3 trial of izokibep in uveitis will also continue through its primary endpoint, with top-line data expected later this year. Mina Kim, Acelyrin’s chief executive officer, said: “While [this] positive HS data and previously announced PsA data supports a path to approval for izokibep, we have determined that a programme of this breadth and size is best brought to market by a larger organisation with the resources and existing footprint in these indications.” The company outlined that it will now be prioritising the development of lonigutamab, an anti-IGF-1R monoclonal antibody being evaluated as a treatment for thyroid eye disease (TED). A phase 2 dose-ranging study of the candidate is ongoing and Acelyrin hopes to initiate a phase 3 trial of the drug early next year. “We remain excited by the opportunity for lonigutamab to address unmet needs of patients with TED. Consistent with our commitment to disciplined capital allocation, we have decided to focus our eﬀorts toward rapidly advancing lonigutamab through late-stage development with our existing cash resources,” Kim said.

临床3期临床2期临床结果

2024-08-24

·佰傲谷BioValley

一场甩锅CRO的闹剧后

在2023年的纳斯达克交易市场上，一家名为Acelyrin的初创公司的IPO备受瞩目，赚足了投资者们的目光，以5.4亿美元融资金额，创下近两年来生物技术初创公司募资规模最大的一次IPO。上市当日，Acelyrin股价大涨30.56%，市值达到21亿美元，Acelyrin股价峰值最高达29.8美元/股。无论是从发行价、发行规模，还是首日涨幅，都足以体现资本市场对其热情之高。然而，从风光上市到陷入困境，Acelyrin仅花了不到一年时间。如同其他Biotech公司一样，Acelyrin在过去的一年多时间中经历了临床失败，高管辞职，和战略重组。如今，公司的股价已经跌至不足5美元，总市值仅为4.75亿美元。风光无限的IPO Acelyrin成立2020年，是一家以License in为主要经营模式的Biotech公司。 Acelyrin在引进方面有一个较为突出的优点，就是聚焦。虽然凭借与被安进278亿美元收购Horizon公司相同的创始团队背景，Acelyrin在一级市场就已获得投资人青睐，但Acelyrin并没有在融到钱后大肆的买进管线，而是始终把重心押注在Izokibep这一条管线上。也是依靠这一条管线，支撑公司成功走到了IPO。 Izokibep是一种IL-17A抑制剂，是Acelyrin于2021年11月以2500万美元首付款+3亿美元里程碑付款从Affibody收购获得。 Izokibep的分子量仅为单抗的十分之一，可以通过皮下注射，达到传统单抗静脉给药的吸收水平。同时Izokibep还拥有不输于单抗的半衰期，在皮肤、关节等组织器官领域有着独特治疗优势。 Acelyrin也围绕银屑病关节炎 (PsA) 、化脓性汗腺炎（HS）、葡萄膜炎、中轴型脊柱关节炎 (AxSpA)多个适应症进行了临床开发。与CRO间的相互甩锅然而上市几个月后，这条支柱管线就遭遇临床挫折。2023年9月11日，宣布Izokibep治疗化脓性汗腺炎的Ⅱb/Ⅲ期临床未达到主要终点HiSCR。作为Acelyrin的核心支柱管线，化脓性汗腺炎又是其开发的关键适应症，这一临床失败消息立即引发了市场的剧烈反应，Acelyrin股价暴跌62%。 Acelyrin自然不愿轻易接受这个结果，根据公司当时对失败原因的推测，Acelyrin认为临床终点未达到可能是受到停药的影响，也可能是源自临床试验设计缺陷。总之，Acelyrin对izokibep的治疗潜力持乐观态度。顺着这一推测，Acelyrin很快找到了为该临床失败的买单方--其合作的CRO公司Fortrea。2023年11月27日，Acelyrin公告发文表示，Fortrea在Izokibep进行银屑病关节炎（PsA）临床试验时犯了“临床方案执行错误”，导致公司遭受损失。尽管Acelyrin没有直指这项失败的临床试验，但公司的里话外都暗示有可能CRO的临床执行失误导致的，因为该项临床也是由该CRO公司负责推进的。而Fortrea认为Acelyrin在甩锅，这家在向美国证券交易委员会提交的一份文件中表示，对Acelyrin发布的关于izokibep两项临床试验声明准确性提出了质疑。尽管甩锅事件至今并没有定论，但无疑对Acelyrin和Fortrea来说都是双输局面，两家公司合作关系因此彻底崩裂，Acelyrin表示以后不会再与Fortrea合作，而Acelyrin也并没有因此挽救它的股价，反而该事件公布后又下跌了30% 。被下调优先级虽然Izokibep遭遇临床失败，但远远还没有到希望彻底破灭的程度，并且在今年3月，Izokibep在化脓性汗腺炎在长期随访和治疗银屑病关节炎两个适应症解取得了积极的数据。但甩锅事件似乎招致了投资人对公司的信任问题，这则公告也似乎暗示了Izokibep在银屑病关节炎中取得的数据并不乐观，而且也让投资者对Acelyrin的执行力产生了怀疑。今年5月，创始人兼首席执行官Shao-Lee Lin已经辞职，由其首席法律和行政官Mina Kim接任CEO职位。而新CEO上任后也采取了重组措施，将裁员33%，调整管线优先级，以将现金跑道延长至2027年中期。这个重组方案还是令大跌眼镜，这款支撑一路走来的核心管线竟然被下调优先级，不再是公司最首要、最优先的管线。根据重组方案，其收购而来的Lonigutamab被列为管线最高优先级，未来将集中精力推进该管线的临床开发，而至于Izokibep，公司将暂停对Izokibep在屑病关节炎和化脓性汗腺炎两个适应症上任何新的资金投入，同时，另一条管线SLRN-517也被移出。 SLRN-517和Lonigutamab均为公司在2023年年初收购ValenzaBio公司而来的管线，Lonigutamab是一种靶向IGF-1R单抗，在甲状腺眼病中进行临床Ⅰ期试验。SLRN-517是一种靶向c-KIT的全人源IgG1单克隆抗体，用于治疗慢性荨麻疹，还未进入临床阶段。参考出处 https://firstwordpharma.com/story/5885299 https://www.globenewswire.com/Tracker?data=dhmrDtQKPFF1IhgI0S2yTK772QTWGDGRI1FcQfHCWgDBN56HAgvrzH9Ve3eeuqDsGep0d2t9WDXciMoxG5qTwTEJJiqaqY3V843UX8KUOwk6G099PVajJLa5T0J1WpcTAf1VdXy_w-xRe3JLRk0LdWo-N31TRZWrX-InpgjFJ8Y= 本周好文推荐如需转载请联系佰傲谷并在醒目位置注明出处 · · · · · · · ·

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100 项与 Izokibep 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
化脓性汗腺炎	临床3期	美国	ACELYRIN, Inc.	2023-06-01
银屑病关节炎	临床3期	美国	ACELYRIN, Inc.	2022-11-21
银屑病关节炎	临床3期	保加利亚	ACELYRIN, Inc.	2022-11-21
银屑病关节炎	临床3期	加拿大	ACELYRIN, Inc.	2022-11-21
银屑病关节炎	临床3期	捷克	ACELYRIN, Inc.	2022-11-21
银屑病关节炎	临床3期	德国	ACELYRIN, Inc.	2022-11-21
银屑病关节炎	临床3期	匈牙利	ACELYRIN, Inc.	2022-11-21
银屑病关节炎	临床3期	波兰	ACELYRIN, Inc.	2022-11-21
银屑病关节炎	临床3期	西班牙	ACELYRIN, Inc.	2022-11-21
斑块状银屑病	临床3期	中国	脉金生物医药科技（上海）有限公司初创企业	2022-03-21

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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


NCT05623345 (22104, EULAR2024) 人工标引	临床2/3期	银屑病关节炎	343	IZO 160 mg Q2W	範窪壓憲鏇鹽鹽築範繭(繭蓋鏇簾衊淵壓餘鹹淵) = 壓觸窪鹽積鏇蓋壓構艱淵襯顧繭淵構廠網繭鏇 (壓觸鹹遞壓鹽網衊蓋衊 ) 更多	积极	2024-06-12
				IZO 160 mg QW	範窪壓憲鏇鹽鹽築範繭(繭蓋鏇簾衊淵壓餘鹹淵) = 膚範築艱醖艱壓繭壓憲淵襯顧繭淵構廠網繭鏇 (壓觸鹹遞壓鹽網衊蓋衊 ) 更多
NCT05623345 (GlobeNewswire) 人工标引	临床2/3期	银屑病关节炎	351	izokibep	窪膚鏇鬱襯繭範鏇願窪(壓夢壓鬱積窪鹹餘選觸) = Study met primary endpoint of ACR50 at 16 weeks versus placebo with high statistical significance 獵製繭獵遞顧鹹製鑰簾 (壓憲膚壓遞壓憲窪鹹壓 ) 达到更多	积极	2024-03-11
				placebo
NCT05623345 (GlobeNewswire) 人工标引	临床2/3期	化脓性汗腺炎	175	Izokibep 160 mg QW (Part B NRI)	願廠觸鏇艱繭積鬱網築(觸獵簾壓壓範醖餘遞蓋) = 壓廠艱獵窪鑰蓋齋觸鏇製窪遞艱遞範窪襯艱鏇 (鬱鹽鹽簾顧獵壓壓遞鑰 ) 更多	不佳	2023-09-11
				Izokibep 160 mg Q2W (Part B NRI)	願廠觸鏇艱繭積鬱網築(觸獵簾壓壓範醖餘遞蓋) = 獵鏇夢積觸範壓築鹹積製窪遞艱遞範窪襯艱鏇 (鬱鹽鹽簾顧獵壓壓遞鑰 ) 更多
Phase 2b/3 Study (EADV2023)	临床2/3期	化脓性汗腺炎	-	Izokibep 160mg	憲獵獵淵鹹窪衊網衊艱(簾壓膚餘範醖餘鬱蓋餘) = 3 SAEs were observed in 2 subjects: inflammatory bowel disease, an exclusionary criterion, in 1 subject with pre-existing symptoms; and peri-colonic abscess/sepsis in another subject with pre-existing symptoms and known diverticulosis 選鹹鑰膚夢築廠醖網選 (鑰廠鹹窪獵憲艱範鑰廠 ) 更多	-	2023-05-18
NCT04713072 (ABY-035-202, PRNewswire) 人工标引	临床2期	银屑病关节炎	-	Izokibep 80 mg Q2W	鑰選襯範艱齋範遞願網(夢蓋膚願遞網製夢選觸) = 夢製鏇衊製網夢襯衊夢構選艱襯艱獵鹹鑰獵夢 (顧構餘壓蓋鑰壓艱窪鬱 ) 更多	积极	2023-04-11
				Izokibep 40 mg Q2W	鑰選襯範艱齋範遞願網(夢蓋膚願遞網製夢選觸) = 餘獵憲壓鹹艱餘鏇獵鹹構選艱襯艱獵鹹鑰獵夢 (顧構餘壓蓋鑰壓艱窪鬱 ) 更多
NCT04713072 (ACR2022) 人工标引	临床2期	银屑病关节炎	135	Izokibep 40mg	簾鹽憲膚衊壓網憲顧鹹(範鹽窪憲顧鑰遞襯觸餘) = 衊膚構築簾鏇廠鏇鏇網鑰齋築襯願餘範膚網網 (夢獵淵蓋積襯積窪顧艱 ) 更多	积极	2022-11-13
				Izokibep 80mg	簾鹽憲膚衊壓網憲顧鹹(範鹽窪憲顧鑰遞襯觸餘) = 願衊壓淵構鏇網蓋鑰鑰鑰齋築襯願餘範膚網網 (夢獵淵蓋積襯積窪顧艱 ) 更多
ACR2022	N/A	银屑病关节炎	-	Izokibep 40 mg Q2W	醖網膚觸網願繭壓簾築(構蓋窪獵願積構簾衊壓) = 觸餘構蓋鏇簾鹹築遞膚築窪顧鏇淵夢廠醖淵範 (鬱鑰選淵淵顧糧顧觸鬱 ) 更多	-	2022-11-13
				Izokibep 80 mg Q2W	醖網膚觸網願繭壓簾築(構蓋窪獵願積構簾衊壓) = 願艱膚網觸蓋糧繭糧築築窪顧鏇淵夢廠醖淵範 (鬱鑰選淵淵顧糧顧觸鬱 ) 更多
NCT04713072 (EULAR2022)	临床2期	银屑病关节炎 IL-17	135	Izokibep 80mg	繭積衊鏇襯簾鏇顧襯鏇(選觸製製遞鏇膚窪膚積) = 繭壓觸蓋齋築壓衊觸鬱糧積衊構構窪壓憲遞醖 (觸夢鑰夢獵糧願醖淵築 )	积极	2022-06-01
				Izokibep 40mg	繭積衊鏇襯簾鏇顧襯鏇(選觸製製遞鏇膚窪膚積) = 簾觸獵鏇願淵鏇膚窪繭糧積衊構構窪壓憲遞醖 (觸夢鑰夢獵糧願醖淵築 )