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临床2/3期

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

/ Terminated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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项与 Izokibep 相关的文献（医药）

2025-01-01·BIODRUGS

Interleukin-17 Inhibitors in the Treatment of Hidradenitis Suppurativa

Review

作者: Yilmaz, Orhan ; Torres, Tiago ; Pinto Salgueiro, Gonçalo ; Nogueira, Miguel

Hidradenitis suppurativa (HS) is a chronic, debilitating, inflammatory dermatosis that significantly impacts patients' quality of life, primarily manifesting as inflammatory nodules, abscesses, and tunnels. The pathogenesis of HS is not fully understood and appears to be multifactorial, involving genetic, immunological, and endocrinological factors, as well as dysbiosis of skin microbiota. Increasing evidence highlights the role of the interleukin (IL)-17 pathway in the inflammatory process and pathogenesis of HS. Consequently, IL-17 inhibitors have emerged as a promising alternative to current therapies. Recently, secukinumab received approval from both the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA), while bimekizumab received approval from the EMA, for the treatment of moderate-to-severe HS in adults, with ongoing clinical trials aiming to further clarify the efficacy and safety of other drugs within this class. IL-17 inhibitors have shown effectiveness in treating moderate-to-severe HS, with safety profiles of drugs such as secukinumab and bimekizumab being comparable to their use in other dermatological conditions. On the other hand, innovative drugs such as sonelokimab and izokibep show promising results and are currently in phase III clinical trials. This review provides a comprehensive overview of current knowledge and scientific advances in HS, focusing on the IL-17 pathway's role and its inhibition as a treatment strategy, alongside examining the most recent and significant clinical studies on various IL-17 inhibitors in the treatment of HS.

2025-01-01·CYTOKINE & GROWTH FACTOR REVIEWS

Interleukin-17: A pleiotropic cytokine implicated in inflammatory, infectious, and malignant disorders

Article

作者: Kurzrock, Razelle ; Lippman, Scott M ; Nishizaki, Daisuke ; Kato, Shumei ; Saran, Anushka

IL-17A, referred to as IL-17, is the founding member of a family of pro-inflammatory cytokines, including IL-17B, IL-17C, IL-17D, IL-17E (or IL-25), and IL-17F, which act via receptors IL-17RA to IL-17RE, and elicit potent cellular responses that impact diverse diseases. IL-17's interactions with various cytokines include forming a heterodimer with IL-17F and being stimulated by IL-23's activation of Th17 cells, which can lead to inflammation and autoimmunity. IL-17 is implicated in infectious diseases and inflammatory disorders such as rheumatoid arthritis and psoriasis, promoting neutrophil recruitment and anti-bacterial immunity, but potentially exacerbating fungal and viral infections, revealing its dual role as protective and pathologic. IL-17 is also involved in various cancers, including breast, colon, cervical, prostate, and skin cancer, contributing to proliferation, immune invasion, and metastases, but also playing a protective role in certain instances. Four FDA-approved drugs-secukinumab (for ankylosing spondylitis, enthesitis-related arthritis, hidradenitis suppurativa, non-radiographic axial spondyloarthritis, plaque psoriasis, and psoriatic arthritis), ixekizumab (for ankylosing spondylitis, non-radiographic axial spondyloarthritis, plaque psoriasis, and psoriatic arthritis), brodalumab (for plaque psoriasis), and bimekizumab (for plaque psoriasis)-suppress the IL-17 pathway, with more in development, including netakimab, sonelokimab, izokibep, and CJM112. These agents and others are being studied across a spectrum of disorders. Understanding the complicated interplay between IL-17 and other immune mediators may yield new treatments for inflammatory/autoimmune conditions and malignancies.

2024-06-01·Annals of the rheumatic diseases

Efficacy and safety of pharmacological treatment of psoriatic arthritis: a systematic literature research informing the 2023 update of the EULAR recommendations for the management of psoriatic arthritis

Review

作者: Ferreira, Ricardo J O ; Gossec, Laure ; Esbensen, Bente Appel ; McInnes, Iain B ; Boehncke, Wolf-Henning ; van der Heijde, Désirée ; Kerschbaumer, Andreas ; Bertheussen, Heidi ; Smolen, Josef S ; Baraliakos, Xenofon ; McGonagle, Dennis G ; Aletaha, Daniel ; Schoones, Jan W ; Winthrop, Kevin L

Objectives:

To obtain an overview of recent evidence on efficacy and safety of pharmacological treatments in psoriatic arthritis (PsA).

Methods:

This systematic literature research (SLR) investigated the efficacy and safety of conventional synthetic (cs), biological (b) and targeted synthetic (ts) disease-modifying antirheumatic drugs (DMARDs) in patients with PsA. A systematic database search using Medline, EMBASE, Cochrane CENTRAL was conducted to identify relevant articles published since the previous update in 2019 until 28 December 2022. Efficacy was assessed in trials while for safety observational data were also considered. Adverse events of special interest were infections (including herpes zoster, influenza and tuberculosis), malignancies, major adverse cardiovascular events, venous thromboembolisms, liver disease, laboratory changes and psychiatric adverse events. No meta-analyses were performed.

Results:

For efficacy, of 3946 articles screened, 38 articles (30 trials) were analysed. The compounds investigated included csDMARDs (leflunomide, methotrexate), bDMARDs inhibiting IL17 (bimekizumab, brodalumab, ixekizumab, izokibep, secukinumab,), IL-23 (guselkumab, risankizumab, tildrakizumab), IL-12/23 (ustekinumab) as well as TNF (adalimumab, certolizumab-pegol, etanercept, infliximab, golimumab) and Janus Kinase inhibitors (JAKi) (brepocitinib, deucravacitinib, tofacitinib, upadacitinib). The compounds investigated were efficacious in improving signs and symptoms of PsA, improving physical functioning and quality of life. For safety, 2055 abstracts were screened, and 24 articles analysed: 15 observational studies and 9 long-term follow-ups of trials, assessing glucocorticoids, TNFi, IL-17i, JAKi, IL-12/23i and PDE4i (apremilast). Safety indicators were generally coherent with the previous SLR in 2019.

Conclusion:

The results of this SLR informed the task force responsible for the 2023 update of the European Alliance of Associations for Rheumatology recommendations for pharmacological management of PsA.

153

项与 Izokibep 相关的新闻（医药）

2025-03-12

·PRNewswire

Psoriatic Arthritis Market Sees Major Shift with Growing Biosimilar Adoption | DelveInsight

The arrival of biosimilars like Celltrion's STEQEYMA and Biocon's YESINTEK is shaking up the psoriatic arthritis market, challenging blockbuster biologics with cost-effective alternatives. As competition intensifies, these biosimilars are reshaping treatment choices and driving a shift in the market landscape. LAS VEGAS, March 12, 2025 /PRNewswire/ -- Psoriatic arthritis (PsA) is a chronic inflammatory condition that affects approximately 112 per 100,000 adults worldwide. It is more prevalent in Europe and North America than in Asia and South America. In patients with psoriasis, the prevalence of psoriatic arthritis can range from 6% to 34% in Western populations. Despite its impact, many individuals with psoriatic arthritis remain undiagnosed or receive inadequate treatment, highlighting the need for increased awareness and access to specialized care. As per DelveInsight analysis, among the 7MM, the United States accounted for the highest number of prevalent cases of psoriatic arthritis in 2023, and these cases are expected to increase by the end of 2034 due to several key factors such as an increase in awareness and diagnosis, as well as the rapid prevalence of PsA. Psoriatic arthritis, occurring in approximately 20% of individuals with psoriasis, is a chronic inflammatory arthritis intricately linked to psoriatic arthritis. This aggressive condition is characterized by potential significant morbidity and compromised quality of life. Treatment approaches for psoriatic arthritis encompass a variety of strategies aimed at managing symptoms, slowing disease progression, and improving the overall quality of life. These approaches typically involve a combination of pharmacological therapies, lifestyle modifications, and, in severe cases, surgical interventions. Psoriatic arthritis treatment is highly individualized based on disease severity, response to therapy, and patient preferences, with multidisciplinary care from rheumatologists, dermatologists, and physical therapists playing a key role. Pharmacological treatment for psoriatic arthritis primarily targets inflammation and pain relief. Nonsteroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen and naproxen, are often the first line of defense, helping to reduce pain and inflammation. Disease-modifying antirheumatic drugs (DMARDs) like methotrexate, sulfasalazine, and leflunomide are commonly prescribed to prevent joint damage and suppress the inflammatory process. For individuals with mild-to-moderate psoriatic arthritis, oral small molecules (OSMs) like OTEZLA (apremilast) offer a convenient, non-injectable option by modulating inflammatory pathways. Biologic agents have revolutionized the treatment landscape for psoriatic arthritis. These medications specifically inhibit key molecules in the inflammatory cascade. TNF inhibitors like HUMIRA (adalimumab), ENBREL (etanercept), and REMICADE (infliximab) are frontline biologics that target tumor necrosis factor, a crucial driver of inflammation. Patients who do not respond to TNF inhibitors may benefit from IL-17 inhibitors like COSENTYX (secukinumab) and TALTZ (ixekizumab) or IL-12/23 inhibitors such as STELARA (ustekinumab). Learn more about the FDA-approved psoriatic arthritis drugs @ Drugs for Psoriatic Arthritis Treatment SKYRIZI (risankizumab), developed by AbbVie, is a humanized IgG1 monoclonal antibody that acts as an interleukin-23 (IL-23) antagonist. It can be used on its own or in conjunction with non-biologic DMARDs. In June 2022, the FDA approved SKYRIZI as the first and only targeted IL-23 inhibitor for adults with active psoriatic arthritis. Another biologic, TREMFYA (guselkumab by Janssen), was approved by the FDA in July 2020 as the first monoclonal antibody that selectively binds to the p19 subunit of IL-23, further expanding treatment options for psoriatic arthritis patients. BIMZELX (bimekizumab), developed by UCB Biopharma, is a humanized monoclonal antibody that targets IL-17A and IL-17F. It received European Commission approval in June 2023 for adults with active psoriatic arthritis and axial spondyloarthritis. On September 23, 2024, the FDA approved BIMZELX for treating adults with active psoriatic arthritis, non-radiographic axial spondyloarthritis (nr-axSpA) with objective inflammation, and active ankylosing spondylitis. In Phase III studies, BIMZELX showed meaningful responses in patients with inadequate TNF inhibitor responses and those new to biologics, indicating its potential as an important treatment option for psoriatic arthritis. In cases where joint damage becomes severe and unresponsive to medical therapies, surgical interventions like joint replacement surgery may be necessary to restore function and alleviate pain. Lifestyle changes, such as regular exercise, joint protection techniques, and weight management, are also critical in managing psoriatic arthritis, as excess weight can worsen symptoms and increase disease severity. The treatment landscape for psoriatic arthritis continues to evolve, offering hope to patients with more targeted therapies and improved outcomes. As companies like UCB Biopharma, AbbVie, and Janssen advance their biologic portfolios, the future looks promising for psoriatic arthritis management. The competition in the biosimilar market is intensifying as companies introduce cost-effective alternatives to blockbuster biologics. In December 2024, Celltrion announced FDA approval for STEQEYMA (ustekinumab-stba), a biosimilar to STELARA, for subcutaneous injection or intravenous infusion in adult and pediatric patients with plaque psoriasis and psoriatic arthritis, as well as adult patients with Crohn's disease and ulcerative colitis. Simultaneously, Biocon Biologics Ltd. is strengthening its position with positive Phase III results for YESINTEK, its biosimilar to ustekinumab, in adult patients with moderate to severe chronic plaque psoriasis. The pivotal randomized, double-blind, parallel-group study demonstrated comparable efficacy and safety to the reference biologic, STELARA, and the findings are being presented at the 2025 American Academy of Dermatology (AAD) Annual Meeting in Orlando, Florida. With the approval of STEQEYMA and the promising clinical outcomes for YESINTEK, these biosimilars are poised to challenge STELARA by offering cost-effective alternatives in key immunology indications. As pricing pressures and healthcare sustainability concerns drive the demand for biosimilars, these developments mark a significant shift in the treatment landscape, providing greater accessibility and affordability for patients while increasing competition in the immunology market. To know more about psoriatic arthritis treatment options, visit @ New Treatment for Psoriatic Arthritis The psoriatic arthritis market is buzzing with numerous companies advancing treatments to cater to the growing patient base. Several therapies are expected to enter the market during the forecast period, providing new hope for patients. Some of these potential therapies include ACELYRIN Inc.'s Izokibep, Novartis Pharmaceuticals' Secukinumab, UCB Biopharma SRL's Bimekizumab, and Bristol-Myers Squibb's Deucravacitinib. Additionally, AbbVie's Upadacitinib and Risankizumab, as well as Eli Lilly and Company's Ixekizumab, are also part of the promising pipeline. Other noteworthy therapies include Sun Pharma's ILUMYA/ILUMETRI, Bristol-Myers Squibb's SOTYKTU, and Affibody's Izokibep in collaboration with Acelyrin and Inmagene. With these advancements, the psoriatic arthritis treatment landscape is set for a major shift, offering patients more tailored and effective options. The companies involved in developing biosimilars include Alvotech, Teva, Biocon Biologics, Celltrion, Fresenius Kabi, and others. Discover which therapies are expected to grab major psoriatic arthritis market share @ Psoriatic Arthritis Market Report ILUMYA/ILUMETRI by Sun Pharma is an interleukin-23 (IL-23) inhibitor classified as a humanized, anti-IL-23p19 monoclonal antibody. It works by blocking inflammatory proteins (cytokines and chemokines) in the body. By inhibiting the effects of IL-23, ILUMYA helps control the release of other inflammatory proteins, including IL-17 and TNF-α. This mechanism reduces inflammation, decreases the number of inflammatory cells in psoriatic lesions, helps prevent plaque formation, and resolves tissue damage. The drug is currently undergoing evaluation in Phase III clinical development, actively recruiting subjects with active psoriatic arthritis who have prior exposure to anti-TNF agents, as well as those who are anti-TNF naïve. SOTYKTU, developed by Bristol-Myers Squibb, is the first and only novel oral selective tyrosine kinase 2 (TYK2) inhibitor being studied across multiple immune-mediated diseases. Deucravacitinib binds to the regulatory domain of the TYK2 enzyme, inhibiting its activation. This selective inhibition reduces the release of proinflammatory cytokines and chemokines, helping to control the inflammation associated with psoriatic arthritis and alleviating its signs and symptoms. Currently, the drug is being investigated for the treatment of psoriatic arthritis in a Phase III clinical trial. Izokibep, developed by Affibody in partnership with Acelyrin and Inmagene, is a unique antibody mimetic and a novel bispecific agent that potentially targets both subunits of the IL-17A homo-dimer and serum albumin. Affibody has entered into a partnership agreement with Acelyrin for the development and commercialization of izokibep and has completed a Phase II trial. As part of this agreement, Acelyrin obtained worldwide rights to izokibep, excluding selected Asian countries, where rights have been granted to Inmagene Biopharmaceuticals. In March 2024, Acelyrin announced the release of positive top-line results from the Phase IIb/III trial, indicating that izokibep was well-tolerated with a favorable safety profile. This drug is currently in Phase III clinical trial. Discover more about drugs for psoriatic arthritis in development @ Psoriatic Arthritis Clinical Trials The anticipated launch of these emerging therapies for psoriatic arthritis is poised to transform the market landscape in the coming years. As these cutting-edge treatments continue to mature and gain regulatory approval, they are expected to reshape the psoriatic arthritis market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth. DelveInsight estimates that the psoriatic arthritis market size was USD 9 billion in 2021 and is expected to grow significantly in the coming years. This growth can be attributed to the introduction of upcoming therapies and the rising prevalence of the condition. The anticipated launch of these therapies is also expected to attract new entrants to the psoriatic arthritis market, resulting in increased competition and innovation. DelveInsight's latest published market report titled " Psoriatic Arthritis Market Insight, Epidemiology, and Market Forecast – 2034" will help you discover which market leader is set to capture the largest market share. The report provides comprehensive insights into country-specific treatment guidelines, patient pool analysis, and epidemiology forecasts to help understand key opportunities and assess the market's underlying potential. The psoriatic arthritis market report offers epidemiological analysis for the study period 2020–2034 in the 7MM, segmented into: Total Prevalent Cases of Psoriatic Arthritis Total Diagnosed Prevalent Cases of Psoriatic Arthritis Gender-specific Diagnosed Prevalent Cases of Psoriatic Arthritis Severity-specific Diagnosed Prevalent Cases of Psoriatic Arthritis The report provides an edge while developing business strategies by understanding trends shaping and driving the 7MM Psoriatic Arthritis market. Highlights include: 10-year Forecast 7MM Analysis Epidemiology-based Market Forecasting Historical and Forecasted Market Analysis upto 2034 Emerging Drug Market Uptake Peak Sales Analysis Key Cross Competition Analysis Industry Expert's Opinion Access and Reimbursement Download this psoriatic arthritis market report to assess the epidemiology forecasts, understand patient journeys, gain insights into KOLs' opinions about upcoming treatment paradigms, and identify the factors contributing to changes in the psoriatic arthritis market. Additionally, stay informed about the mitigating factors that can enhance your market position in the psoriatic arthritis therapeutic space. Related Reports Psoriatic Arthritis Pipeline Psoriatic Arthritis Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key schizophrenia companies, including Affibody, Kymera, Selection Therapeutics GmbH, Jiangsu HengRui Medicine Co., Ltd., Nimbus Lakshmi, Inc., Hansoh BioMedical R&D Company, Bio-Thera Solutions, ACELYRIN Inc., among others. Psoriatic Arthritis Epidemiology Forecast Psoriatic Arthritis Epidemiology Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, and Psoriatic Arthritis epidemiology trends. Ankylosing Spondylitis Market Ankylosing Spondylitis 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 Ankylosing Spondylitis companies, including UCB, AbbVie, Pfizer, Astella, Amgen, Janssen Biotech, Pozen, Novartis, Iroko Pharmaceuticals, Syntex Pharmaceuticals, Horizon Pharma, Eli Lilly and Company, among others. Psoriasis Market Psoriasis Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key Psoriasis companies, including Amgen, Janssen, Abbvie, Novartis, AstraZeneca, Bausch Health, Eli Lilly, Sun Pharmaceutical, Janssen Biotech, UCB Inc., LEO Pharma, Promius Pharma, Mayne Pharma, Bausch Health Companies, MC2 Therapeutics, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

临床3期上市批准临床结果临床2期

2025-03-05

·BioSpace

Acelyrin Rejects Concentra’s Buyout Offer in Favor of Alumis Merger

iStock, Polinmr Acelyrin and Alumis plan to close their merger in the second quarter of 2025, pending clearances and shareholder approval. Acelyrin declined a surprise acquisition offer from Concentra Biosciences on Tuesday, instead doubling down on its previously announced merger with fellow immune specialist Alumis. “The unsolicited indication of interest from Concentra Biosciences, LLC . . . is not reasonably expected to result in a superior proposal to the planned merger with Alumis Inc.,” Acelyrin wrote in its press announcement—a conclusion that it reached after consulting with independent financial and legal advisors. “The Acelyrin Board of Directors is confident that the all-stock transaction with Alumis maximizes long-term value for Acelyrin stockholders,” the news release stated. Acelyrin management recommends that shareholders back the merger. Acelyrin and Alumis expect to close the transaction in the second quarter of 2025, pending regulatory clearances, approval by stockholders and other customary conditions. Once complete, the combined entity will carry Alumis’ name and will pool together the two companies’ standing resources: around $448 million from Acelyrin and $289 million from Alumis. The resulting cash position should be enough to tide the new company over until 2027. The post-merger Alumis will also advance a drug pipeline with the combined assets of both companies. This includes the tyrosine kinase 2 inhibitors ESK-001, being tested in mid- to late-stage trials for moderate-to-severe plaque psoriasis and lupus, and A-005, in early-stage development for neuroinflammatory and neurodegenerative disorders. The combined company will also work on Acelyrin’s lonigutamab, a subcutaneous monoclonal antibody in Phase II for thyroid eye disease and Acelyrin’s only remaining candidate after the company announced in December 2024 that it had discontinued the development of its lead candidate izokibep, an investigational IL-17A inhibitor that had been in trials for psoriasis and other inflammatory conditions. Findings for lonigutamab revealed in January 2025 showed that the asset could elicit “ clinically meaningful and competitive improvements ” in various disease symptoms, including clinical activity and diplopia, the biotech said at the time. Acelyrin and Alumis revealed plans to merge in early February, but two weeks later Concentra sought to disrupt the transaction by offering to snap up Acelyrin for $3 per outstanding share. The Kevin Tang-controlled company also added a contingent value right offer that would entitle Acelyrin to 80% of proceeds from deals concerning its assets and intellectual properties. Concentra has previously tried to get in between prospective partners. In March 2023, for instance, Concentra broke up a planned merger between Jounce Therapeutics and Redx Pharma, ultimately, winning Jounce over.

临床2期并购IPO

2025-03-04

·FierceBiotech

Acelyrin doubles down on Alumis merger after deciding Concentra\'s surprise offer \'not superior\'

Tang Capital Partners-owned Concentra has a mixed success rate when it comes to acquisitions.\n Acelyrin has declined a surprise offer from Concentra Biosciences, and is instead pushing ahead with plans to merge with immune-mediated disease specialist Alumis.Los Angeles-based Acelyrin consulted with independent financial and legal advisors and came to the conclusion that the unsolicited interest from Tang Capital Partners-owned Concentra was “not reasonably expected to result in a superior proposal to the planned merger with Alumis,” according to a March 4 release.In late February, Concentra offered to buy all outstanding shares of Acelyrin for $3 per share in cash, along with a contingent value right for Acelyrin’s current shareholders to receive 80% of the net proceeds from the sale or out-license of any of the biotech\'s development programs.The proposition followed an announcement earlier in the month that laid out plans for an Alumis-Acelyrin merger, in which the resulting company would continue under the Alumis name at the biotech’s South San Francisco headquarters under Alumis’ leadership. Stockholders of Alumis—which went public last year—would own 55% of the company, with Acelyrin’s shareholders comprising the remaining 45%.The two California biotechs are now reaffirming the merger plans, with the deal expected to close in the second quarter of this year, subject to approval by stockholders from both companies, according to a separate March 4 release. “The Acelyrin board of directors is confident that the all-stock transaction with Alumis maximizes long-term value for Acelyrin stockholders and continues to recommend that stockholders support the planned merger,” CEO Mina Kim said in the release. “We chose to enter into the merger agreement with Alumis after a comprehensive assessment of strategic alternatives and believe this is the best outcome for Acelyrin stockholders.”The expanded Alumis will take its pick from the two companies’ pipelines. This includes continuing with its own ESK-001, an allosteric tyrosine kinase 2 inhibitor in a phase 3 plaque psoriasis trial, as well as the TYK2 inhibitor A-005, which is being lined up for a phase 2 trial in multiple sclerosis later this year.The company will also take forward Acelyrin’s anti-IGF-1R monoclonal antibody lonigutamab, which is in a phase 2 trial for thyroid eye disease. Recent months have proved tough for Acelyrin, which laid off a third of its workforce last summer as the biotech shifted attention from its former lead asset izokibep to lonigutamab, with hopes that the latter could rival Amgen\'s eye disease blockbuster Tepezza.After Acelyrin threw in the towel on izokibep, the company returned the drug back to its former partner Affibody, which claimed that Acelyrin hadn’t “been able to fully capitalize” on izokibep’s potential. But now Acelyrin is anticipating brighter days upon merging, with the new entity expected to have about $737 million on hand. That estimate combines Alumis’ $289 million and Acelyrin’s $448 million in cash, cash equivalents and marketable securities as of Dec. 31, 2024. The combined cash runway is expected to carry the merged biotech into 2027.Alumis brought in one of biotech’s biggest venture capital fundraises of last year when it secured a $259 million series C financing in March 2024. Less than three months after the series C, Alumis revealed plans for a $274 million IPO, downsizing the offer a few days later to debut on the Nasdaq with a $250 million offering.Concentra’s parent company Tang Capital Partners has a track record of swooping in to try to acquire struggling biotechs—with mixed results. The company bought Jounce Therapeutics and Theseus Pharmaceuticals in 2023 but had its advances rejected by Atea Pharmaceuticals, Rain Oncology, LianBio and Kezar Life Sciences.

$Acelyrin doubles down on Alumis merger after deciding Concentra\'s surprise offer \'not superior\'$

临床2期并购IPO临床3期

100 项与 Izokibep 相关的药物交易

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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.	2023-06-22
化脓性汗腺炎	临床3期	日本	ACELYRIN, Inc.	2023-06-22
化脓性汗腺炎	临床3期	加拿大	ACELYRIN, Inc.	2023-06-22
化脓性汗腺炎	临床3期	法国	ACELYRIN, Inc.	2023-06-22
化脓性汗腺炎	临床3期	德国	ACELYRIN, Inc.	2023-06-22
化脓性汗腺炎	临床3期	匈牙利	ACELYRIN, Inc.	2023-06-22
化脓性汗腺炎	临床3期	波兰	ACELYRIN, Inc.	2023-06-22
化脓性汗腺炎	临床3期	西班牙	ACELYRIN, Inc.	2023-06-22
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

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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, EULAR 12024 \| EULAR 22024) 人工标引	临床2/3期	银屑病关节炎	343	IZO 160 mg Q2W	鹹醖糧淵鑰積鬱鬱膚構(繭鏇簾鑰夢憲簾積遞範) = 鏇廠鏇衊範鏇構憲鑰壓範窪憲鬱遞鬱襯積鬱積 (鹽鏇壓鑰窪蓋繭鹽鹹鬱 ) 更多	积极	2024-06-12
				IZO 160 mg QW	鹹醖糧淵鑰積鬱鬱膚構(繭鏇簾鑰夢憲簾積遞範) = 願壓膚簾壓範鹹積顧衊範窪憲鬱遞鬱襯積鬱積 (鹽鏇壓鑰窪蓋繭鹽鹹鬱 ) 更多
NCT05623345 (GlobeNewswire) 人工标引	临床2/3期	银屑病关节炎	351	izokibep	淵積鏇獵願膚餘鑰窪糧(簾衊鬱蓋繭繭憲齋構積) = Study met primary endpoint of ACR50 at 16 weeks versus placebo with high statistical significance 遞憲鬱遞鬱鹹選夢憲製 (夢壓獵範鹹憲膚鬱鏇淵 ) 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)	糧構壓顧糧鹹顧蓋顧糧(選範壓製襯鏇鏇窪鏇蓋) = 廠範鹹製憲膚憲窪網鑰夢願積鹽蓋淵繭糧築蓋 (顧衊製鬱鹹窪積遞糧艱 ) 更多	不佳	2023-09-11
				Izokibep 160 mg Q2W (Part B NRI)	糧構壓顧糧鹹顧蓋顧糧(選範壓製襯鏇鏇窪鏇蓋) = 鏇構積獵窪鏇餘網鏇膚夢願積鹽蓋淵繭糧築蓋 (顧衊製鬱鹹窪積遞糧艱 ) 更多
EADV2023	临床2/3期	化脓性汗腺炎	-	Izokibep 160mg	夢鹹構鬱構夢遞鏇築簾(齋襯顧膚糧製鏇艱蓋衊) = 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 窪蓋積衊構齋鑰餘網獵 (鹽選積淵窪蓋鏇醖壓夢 ) 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	觸膚繭廠窪遞窪衊鏇襯(觸齋製鏇選簾齋築衊鬱) = 淵鬱蓋遞餘簾願醖遞糧顧遞繭鑰築獵憲糧構艱 (齋淵艱選簾廠膚獵衊壓 ) 更多	积极	2023-04-11
				Izokibep 40 mg Q2W	觸膚繭廠窪遞窪衊鏇襯(觸齋製鏇選簾齋築衊鬱) = 糧齋顧壓願鹹齋醖夢製顧遞繭鑰築獵憲糧構艱 (齋淵艱選簾廠膚獵衊壓 ) 更多
NCT04713072 (ACR2022) 人工标引	临床2期	银屑病关节炎	135	Izokibep 40mg	齋顧憲廠齋鬱簾製製壓(簾齋網齋夢簾窪餘範選) = 蓋積製蓋獵遞顧鏇廠築簾簾積範製鹽願鑰襯淵 (觸廠觸衊遞製夢構糧憲 ) 更多	积极	2022-11-13
				Izokibep 80mg	齋顧憲廠齋鬱簾製製壓(簾齋網齋夢簾窪餘範選) = 鬱淵獵積願夢餘夢窪鹹簾簾積範製鹽願鑰襯淵 (觸廠觸衊遞製夢構糧憲 ) 更多