A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Lirentelimab in Adult Subjects With H-1 Antihistamine Refractory Chronic Spontaneous Urticaria

This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of subcutaneous lirentelimab (AK002) in adult subjects with H-1 antihistamine refractory chronic spontaneous urticaria. Subjects who complete the randomized, double-blind, placebo-controlled treatment period may have the option to enroll in an open-label extension period and receive up to 6 doses of subcutaneous lirentelimab.

开始日期2022-10-26

申办/合作机构

Allakos, Inc.

NCT05155085

/ Terminated临床2期

A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Subcutaneous Lirentelimab in Adult Subjects With Moderate-to-Severe Atopic Dermatitis Inadequately Controlled by Topical Treatments

This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of subcutaneous lirentelimab (AK002), given every 2 weeks for 7 doses, in adult subjects with moderate-to-severe AD inadequately controlled by topical treatments. Subjects who complete the randomized, double-blind, placebo-controlled treatment period may have the option to enroll in an open-label extension period and receive up to 7 doses of subcutaneous lirentelimab.

开始日期2022-06-27

申办/合作机构

Allakos, Inc.

NCT05152563

/ Withdrawn临床3期

A Phase 3 Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacodynamic Effect of Subcutaneous AK002 in Subjects With Moderate to Severe Eosinophilic Gastritis and/or Eosinophilic Duodenitis

This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety, tolerability, and pharmacodynamic effect of subcutaneous lirentelimab (AK002), given monthly for 6 doses, in subjects with moderate to severe Eosinophilic Gastritis and/or Eosinophilic Duodenitis who have an inadequate response with, lost response to, or were intolerant to standard therapies.

开始日期2021-12-01

申办/合作机构

Allakos, Inc.

100 项与 Antolimab 相关的临床结果

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100 项与 Antolimab 相关的转化医学

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100 项与 Antolimab 相关的专利（医药）

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项与 Antolimab 相关的文献（医药）

2024-02-01·Current allergy and asthma reports

Mast Cell–Targeting Therapies in Mast Cell Activation Syndromes

Review

作者: Toscano, Alessandro ; Ebo, Didier G ; Van Gasse, Athina ; Sabato, Vito ; Beyens, Michiel

PURPOSE OF REVIEW:

Provide an overview of the expanding landscape of mast cell (MC)-targeting treatments in mast cell activation syndromes (MCAS).

RECENT FINDINGS:

Tyrosine-kinase inhibitors (TKIs) targeting wild-type and mutated KIT can efficiently induce MC depletion. Avapritinib and midostaurin can also temper IgE-mediated degranulation. Avapritinib has been recently approved by the FDA for the treatment of indolent systemic mastocytosis (ISM). Targeting activation pathways and inhibitory receptors is a promising therapeutic frontier. Recently, the anti Siglec-8 antibody lirentelimab showed promising results in ISM. MCAS is a heterogeneous disorder demanding a personalized therapeutic approach and, especially when presenting as anaphylaxis, has not been formally captured as outcome in prospective clinical trials with TKI. Long-term safety of TKI needs to be addressed. New drugs under investigation in diseases in which non-neoplastic MCs play a pivotal role can provide important inputs to identify new efficient and safe treatments for MCAS.

2023-11-01·Gut

Comparison of drugs for active eosinophilic oesophagitis: systematic review and network meta-analysis

Article

作者: Black, Christopher J ; Barberio, Brigida ; Del Corso, Giulio ; de Bortoli, Nicola ; Savarino, Edoardo ; Ford, Alexander C ; Visaggi, Pierfrancesco

Background:

There is currently no recommendation regarding preferred drugs for active eosinophilic oesophagitis (EoE) because their relative efficacy is unclear. We conducted an up-to-date network meta-analysis to compare proton pump inhibitors, off-label and EoE-specific topical steroids, and biologics in EoE.

Methods:

We searched MEDLINE, Embase, Embase Classic and the Cochrane Central Register of Controlled Trials from inception to June 2023. We included randomised controlled trials (RCTs) comparing efficacy of all drugs versus each other, or placebo, in adults and adolescents with active EoE. Results were reported as pooled relative risks with 95% CIs to summarise effect of each comparison tested, with drugs ranked according to P score

Results:

Seventeen RCTs were eligible for systematic review. Of these, 15 studies containing 1813 subjects with EoE reported extractable data for the network meta-analysis. For histological remission defined as ≤6 eosinophils/high-power field (HPF), lirentelimab 1 mg/kg monthly ranked first. For histological remission defined as ≤15 eosinophils/HPF, budesonide orally disintegrating tablet (BOT) 1 mg two times per day ranked first. For failure to achieve symptom improvement, BOT 1 mg two times per day and budesonide oral suspension (BOS) 2 mg two times per day were significantly more efficacious than placebo. For failure to achieve endoscopic improvement based on the EoE Endoscopic Reference Score, BOT 1 mg two times per day and BOS 1 mg two times per day or 2 mg two times per day were significantly more efficacious than placebo.

Conclusions:

Although this network meta-analysis supports the efficacy of most available drugs over placebo for EoE treatment, significant heterogeneity in eligibility criteria and outcome measures among available trials hampers the establishment of a solid therapeutic hierarchy.

2023-10-25·The British journal of dermatology

A study of the safety and effectiveness of lirentelimab as a treatment for people with indolent systemic mastocytosis.

Article

项与 Antolimab 相关的新闻（医药）

2025-03-12

·GlobeNewswire-Health Care

Allakos Provides Business Update and Reports Fourth Quarter 2024 Financial Results

SAN CARLOS, Calif., March 12, 2025 (GLOBE NEWSWIRE) -- Allakos Inc. (the “Company”) (Nasdaq: ALLK), a biotechnology company that has been developing antibodies for the treatment of allergic, inflammatory and proliferative diseases, today provided a business update and reported financial results for the fourth quarter ended December 31, 2024. Recent Allakos Events Reported topline data from the Phase 1 study of AK006 in patients with chronic spontaneous urticaria in January 2025.Announced in January 2025 that the Company was discontinuing further development of AK006, restructuring operations to reduce costs and exploring strategic alternatives. Cash Guidance Allakos ended the fourth quarter of 2024 with $80.8 million in cash, cash equivalents and investments. Allakos’ financial outlook, restructuring activities and estimated cash outlook as reported by the Company in January 2025 remain unchanged. The Company estimates that cash used in restructuring activities to close out AK006 development, including severance and contractual payments to vendors, will be approximately $34 million to $38 million. The Company also estimates that a significant majority of these restructuring costs will be paid over the first and second quarters of 2025. The Company estimates it will have cash, cash equivalents and investments in a range of approximately $35 million to $40 million at June 30, 2025. Fourth Quarter 2024 Financial Results Allakos ended the fourth quarter of 2024 with $80.8 million in cash, cash equivalents and investments resulting in a net decrease in cash, cash equivalents and investments of $11.9 million during the fourth quarter of 2024. Research and development expenses were $14.8 million in the fourth quarter of 2024 compared to $53.8 million in the fourth quarter of 2023, a decrease of $39.0 million. This quarter over quarter decrease is due to halting lirentelimab development and includes a $31.2 million decrease in contract research and manufacturing costs, $6.7 million of decreased compensation costs and a $1.1 million decrease in other research and development expenses. General and administrative expenses were $9.8 million for the fourth quarter of 2024 compared to $11.2 million for the fourth quarter of 2023, a decrease of $1.4 million. The quarter over quarter change included $2.9 million of decreased compensation costs offset by a $1.5 million increase primarily from professional and other general costs associated with the termination of our office lease. Allakos reported net income of $0.4 million in the fourth quarter of 2024 compared to a net loss of $62.6 million in the fourth quarter of 2023. The gain in the fourth quarter of 2024 was primarily attributed to the $23.9 million gain on lease amendment recognized as a result of the lease termination agreement entered into during the fourth quarter of 2024. About Allakos Allakos is a clinical stage biotechnology company that has been developing therapeutics that target immunomodulatory receptors present on immune effector cells involved in allergy, inflammatory and proliferative diseases. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 as contained in Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Such forward-looking statements include, but are not limited to, Allakos’ expectations regarding its financial position and guidance, including estimated costs of restructuring activities to close out AK006 development, the timing of payment of such restructuring costs, and estimated ending second quarter 2025 cash, cash equivalents and investments; restructuring activities and plans; and exploration of strategic alternatives. Such statements are based on Allakos’ current views about its plans, intentions, expectations, strategies and prospects only as of the date of this release and are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially from those set forth in or implied by such forward-looking statements, including but not limited to: uncertainties related to Allakos’ ability to realize the contemplated benefits of its restructuring activities and related reduction in force; Allakos’ ability to accurately forecast financial results, including restructuring and other costs and expenses; availability of suitable third parties with which to conduct contemplated strategic alternative transactions; whether Allakos will be able to pursue strategic alternative transactions, or whether any transaction, if pursued, will be completed on attractive terms; whether Allakos’ cash resources will be sufficient to fund its foreseeable and unforeseeable operating expenses and capital expenditure requirements; Allakos’ ability to maintain the listing of its common stock on Nasdaq; general economic and market conditions, both domestic and international; risks associated with volatility and uncertainty in the capital markets for biotechnology companies; and other risks. Information regarding the foregoing and additional risks may be found in the section entitled “Risk Factors” in documents that Allakos files from time to time to with the SEC. These documents contain and identify important factors that could cause the actual results for Allakos to differ materially from those contained in Allakos’ forward-looking statements. Any forward-looking statements contained in this press release speak only as of the date hereof, and Allakos specifically disclaims any obligation to update any forward-looking statement, except as required by law. These forward-looking statements should not be relied upon as representing Allakos’ views as of any date subsequent to the date of this press release. Source: Allakos Inc. Investor Contact:Adam Tomasi, PresidentAlex Schwartz, VP Strategic Finance and Investor Relationsir@allakos.com Media Contact:media@allakos.com ALLAKOS INC. UNAUDITED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME AND LOSS (in thousands, except per share data) Three Months Ended Twelve Months Ended December 31, December 31, 2024 2023 2024 2023 Operating expenses Research and development $14,819 $53,801 $79,939 $150,908 General and administrative 9,837 11,182 38,822 45,148 Impairment of long-lived assets — — 27,347 — Gain on lease amendment (23,883) — (23,883) — Total operating expenses 773 64,983 122,225 196,056 Loss from operations (773) (64,983) (122,225) (196,056)Interest income 1,104 2,382 6,450 10,347 Other expense, net 45 50 (43) 8 Net income (loss) 376 (62,551) (115,818) (185,701)Unrealized gain (loss) on investments (198) 122 86 334 Comprehensive income (loss) $178 $(62,429) $(115,732) $(185,367)Net income (loss) per common share: Basic and diluted $0.00 $(0.71) $(1.30) $(2.14)Weighted-average number of common shares outstanding: Basic 89,445 87,567 88,791 86,798 Diluted 90,400 87,567 88,791 86,798 ALLAKOS INC. UNAUDITED CONDENSED BALANCE SHEETS (in thousands) December 31, December 31, 2024 2023 Assets Current assets: Cash and cash equivalents $17,753 $66,440 Investments 63,067 104,354 Prepaid expenses and other current assets 4,766 9,095 Total current assets 85,586 179,889 Property and equipment, net 10,827 33,369 Operating lease right-of-use assets — 24,136 Other long-term assets 188 6,216 Total assets $96,601 $243,610 Liabilities and stockholders’ equity Current liabilities: Accounts payable $5,490 $1,764 Accrued expenses and other current liabilities 12,294 34,814 Total current liabilities 17,784 36,578 Operating lease liabilities, net of current portion — 38,215 Total liabilities 17,784 74,793 Stockholders’ equity: Common stock 90 88 Additional paid-in capital 1,312,886 1,287,156 Accumulated other comprehensive gain (loss) 136 50 Accumulated deficit (1,234,295) (1,118,477)Total stockholders’ equity 78,817 168,817 Total liabilities and stockholders’ equity $96,601 $243,610

财报

2025-01-04

·药事纵横

110个失败临床研究|2024年度总结

声明：因水平有限，错误不可避免，或有些信息非最及时，欢迎留言指出。本文仅作医疗健康相关药物介绍，非治疗方案推荐（若涉及）;本文不构成任何投资建议。 2024年，全球医药研发领域经历了一系列令人瞩目的临床试验失败事件，这些失败不仅揭示了新药研发过程的复杂性和挑战，也促使制药企业重新审视其研发策略和临床试验设计。从慢性阻塞性肺病药物到帕金森病治疗药物，从肿瘤免疫疗法到基因疗法，多个领域的临床研究在历经长时间和大量资源投入后，未能达到其主要终点或关键次要终点。本文汇总了2024年发生的110个重要临床试验失败案例，并对一些失败研究进行详细介绍，探讨失败的原因、影响及对未来新药研发的启示，以期提供参考和借鉴。一月 1月5日，Theravance Biopharma宣布Yupelri（revfenacin）吸入溶液用于慢性阻塞性肺病（COPD）维持治疗的IV期PIFR-2研究未达主要终点。Yupelri 是美国批准用于慢阻肺维持治疗的唯一每日一次的雾化长效毒蕈碱拮抗剂（LAMA）。 1月16日，Allakos宣布lirentelimab在治疗特应性皮炎患者的2期临床试验（ATLAS）和治疗慢性自发性荨麻疹患者的2b期临床试验（MAVERICK）中均未达主要终点。 1月22日，吉利德公布Trop2 ADC新药Trodelvy治疗非小细胞肺癌的三期临床EVOKE-01研究没有达到OS主要终点。EVOKE-01正在评估Trop2 ADC药物Trodelvy®（sacituzumab-govitecan-hziy；SG）与多西他赛在铂类化疗和检查点抑制剂治疗期间或之后进展的转移性或晚期NSCLC患者中的疗效。 1月29日，百时美施贵宝（BMS）宣布其PD-1抑制剂Opdivo在III期CheckMate-914研究的B部分中失败，对于术后存在高复发风险的局部肾细胞癌患者未带来显著的无病生存益处。 1月29号，来凯医药公布afuresertib联合紫杉醇治疗耐药卵巢癌（PROC）（PROFECTA-II）的顶线数据。试验结果表明，afuresertib联合紫杉醇治疗可以降低疾病展或死亡的风险（无进展生存期，PFS )，HR为0.744（95%CI:0.502-1.102），但试验结果不具有统计学意义。二月 2月5日，亚虹医药发布公告宣布其产品APL1202与化疗灌注联合使用治疗化疗灌注复发的中高危非肌层浸润性膀胱癌（NMIBC）的随机、双盲、对照、多中心的关键性临床试验未达到主要研究终点，公司决定终止APL-1202与化疗灌注联合使用在该适应症的进一步开发。 2月7日，Gilead宣布终止CD47单抗magrolimab治疗急性髓性白血病（AML）的3期ENHANCE-3研究，FDA将所有magrolimab治疗骨髓增生异常综合征（MDS）和急性髓性白血病的研究，包括相关的扩大准入项目置于全面临床搁置状态。这些决定是根据独立数据监测委员会的建议做出的，该委员会审查了ENHANCE-3总生存期（OS）中期分析计划的一线数据。在该分析中，magrolimab与阿扎胞苷和venetoclax联用显示出无治疗效果，并观察到死亡风险增加，主要是由感染和呼吸衰竭引起的。 2月8日，Synlogic公司宣布终止Synpheny-3研究，该研究是对labafenogene marselecobac (SYNB1934)作为苯丙酮尿症（PKU）的一种潜在治疗方法正在进行的Ⅲ期临床研究。SYNB1934是利用合成生物学改造的细菌菌株，具有降解苯丙氨酸的能力。终止Synpheny-3试验的决定是基于即将进行的独立数据监测委员会（DMC）评估前的内部审查结果，该结果表明该试验不太可能达到主要终点。 2月8日，阿斯利康在2023年全年业绩报告上公布因疗效不佳，决定终止抗IL-33单抗Tozorakimab联合达格列净治疗糖尿病肾病的IIb期临床研究（NCT04170543）。 2月12日，AN2 Therapeutics宣布自愿暂停无缝II/III期临床试验（EBO-301）中III期研究部分的患者入组，该试验旨在评估口服小分子细菌leucyl-tRNA合成酶抑制剂epetraborole治疗由鸟分枝杆菌复合体（MAC）引起的难治性肺病的疗效与安全性。在对正在进行的第二阶段研究进行盲法汇总分析后，发现疗效可能低于预期，因此决定自愿暂停试验。 2月12日，大冢制药公布了AVP-786（氘代右美沙芬+奎尼丁）治疗阿尔茨海默病痴呆相关激越的III期临床试验（NCT03393520）未达主要疗效终点。 2月13日，Roivant Sciences在财报中披露终止开发SF3B1调节剂RVT-2001用于治疗骨髓增生异常综合征的临床I/II期试验，原因是期中分析结果后有效性不及预期。 2月16日，Denali Therapeutics在SEC文件中透露，DNL788（SAR443820）治疗肌萎缩侧索硬化症（ALS）的II期HIMALAYA研究未能达到显著改善修订版ALS功能评定量表（ALSFRS-R）评分的主要终点。受此消息影响，Denali的股价下跌了近8%。三月 3月4日，Vivoryon Therapeutics公布了口服谷氨酰胺酰环化酶（QPCT）抑制剂varoglutamstat（PQ912）治疗早期阿尔茨海默病（AD）IIb期VIVIAD研究的初步结果。结果显示，VIVIAD研究未达到其主要终点，也未显示出认知能力随时间推移而发生变化的显著统计学差异。此外，该研究未达到测量认知能力、日常生活活动工具问卷和脑电图全局θ功率的关键次要终点。 3月7日，MacroGenics在2023年财报中透露因IMGC936在针对晚期恶性实体瘤的I/II期临床试验中未达到预期内的安全性和有效性目标，将终止该药物的开发。IMGC-936是由MacroGenics原研，后与ImmunoGen（现已被艾伯维收购）合作开发的一款ADAM9 ADC药物。 3月8日，Amylyx Pharmaceuticals公布AMX0035治疗肌萎缩性侧索硬化症（ALS）三期临床PHOENIX的顶线数据，研究没有达到主要终点和次要终点。Amylyx将与监管进行沟通，包括自愿撤市的计划。 3月11日，Acadia Pharmaceuticals公布Pimavanserin治疗精神分裂阴性症状三期临床ADVANCE-2的最新研究结果未达主要终点。研究的主要终点为NSA-16总分从基线到第26周的变化，治疗组和安慰机组26周NSA-16评分分别为-11.8 vs -11.1%，结果不具有统计学意义。安全性和耐受性与之前的临床试验一致，不良事件发生率较低。 3月21日，罗氏合作伙伴Chugai制药（中外制药）公布了Enspryng（萨特利珠单抗）治疗全身型重症肌无力（gMG）的III期LUMINESCE研究结果。虽在其主要终点观察到具有统计学意义的数据，但结果没有达到对临床获益程度的预期。 3月21日，默沙东宣布其PD-1疗法Keytruda联合维持性PARP抑制剂Lynparza（奥拉帕利）一线治疗某些转移性非鳞状非小细胞肺癌（NSCLC）患者的III期KEYLYNK-006试验未达到总生存期（OS）和无进展生存期（PFS）的双重主要终点。 3月28日，BMS宣布1-磷酸鞘氨醇 (S1P) 受体口服小分子调节剂 Zeposia（ozanimod），治疗中重度活动性克罗恩病患者的安慰剂对照临床III期试验YELLOWSTONE研究失败，在第12周未达到临床缓解的主要终点。四月 4月1日，Gritstone bio宣布其个性化癌症疫苗GRANITE在一线转移性微卫星稳定结直肠癌（MSS-CRC）中正在进行的II/III期研究的II期部分的数据。总体来说，该癌症疫苗未能触发循环肿瘤DNA（ctDNA）的变化，导致II期试验未达主要终点。 4月4日，eFFECTOR Therapeutics公布了tomivosertib的一项随机、安慰剂对照II期KICKSTART研究的主要分析结果。基于分层对数秩检验，PFS双侧P值为0.21，未达到p≤0.2的预设阈值。Tomivosertib组的中位生存期为13.0周，安慰剂组的中位生存期为11.7周。总生存期结果仍不成熟，但没有观察到有利于tomivosertib的趋势。 4月15日，Marius Pharmaceuticals公布静脉注射ganaxolone（加奈索隆）治疗难治性癫痫持续状态（RSE）的三期临床RAISE最新数据，此次中期分析未达到预设的终止标准。IDMC建议临床试验继续，Marinus决定完成RAISE试验约100例患者的入组工作，预计在今年夏季得出顶线结果，结果出来后决定是否继续开发。 4月17日，Sage Therapeutics宣布一项针对帕金森病 (PD) 轻度认知障碍 (MCI) 患者的研究性口服药物dalzanemdor (SAGE-718) 的双盲、安慰剂对照2期研究PRECEDENT研究的初步结果未达到主要终点，即在第42天时接受每日一次dalzanemdor治疗的患者与接受安慰剂治疗的患者在WAIS-IV编码测试得分方面与基线相比不存在显著统计学差异。Dalzanemdor (SAGE-718)的耐受性总体良好，没有发现新的安全信号。 4月18日，Biosplice Therapeutics宣布CLK/DYRK激酶抑制剂lorecivivint治疗膝骨关节炎的III期试验OA-21短期疼痛研究未达到第12周疼痛减轻的主要终点。Biosplice目前正在分析这些初步的OA-21试验结果。五月 5月6日，Lyra Therapeutics的核心管线LYR-210在治疗慢性鼻窦炎（CRS）的3期研究中未能达到临床主要终点。后续，Lyra公司宣布，将裁撤管线、停止制造和商业化活动、裁员75%等措施来削减成本以节省资金，保证资金继续推动LYR-210的3期研究和公司运营。 5月6日，GlycoMimetics宣布其主要候选产品uproleselan，在与化疗联合治疗成人复发或难治性急性髓系白血病（R/R AML）的III期研究中未达到总生存期（OS）主要终点。结果显示，与单独化疗相比，uproleselan联合化疗组的OS并没有统计学意义的显著改善。 5月10日，百时美施贵宝（BMS）宣布纳武利尤单抗（Opdivo，O药）治疗不可切除的局部晚期III期NSCLC患者的III期CheckMate-73L研究未达到主要终点。 5月13日，默沙东宣布终止3期KeyVibe-010试验中的抗TIGIT药物vibostolimab 和抗PD-1pembrolizumab（帕博利珠单抗）联合制剂组治疗皮肤癌的后期试验，由于免疫副作用导致大量患者退出。该试验正在评估vibostolimab和帕博利珠单抗的研究组合，与单独使用帕博利珠单抗相比，作为切除的高风险黑色素瘤(ⅡB -Ⅳ期)患者的辅助治疗。 5月13日，盐野义公布新冠口服药Ensitrelvir三期临床最新数据，研究没有达到主要终点治疗到持续症状缓解的时间，尽管数据有所降低，但没有达到统计学显著性差异。盐野义将继续与监管层沟通。 5月28日，康宁杰瑞宣布在未接受系统性治疗的不可切除局部晚期或转移性胰腺导管腺癌(PDAC)患者中，评估其自主研发的PD-L1/CTLA-4双特异性抗体KN046联合白蛋白紫杉醇及吉西他滨对比安慰剂联合白蛋白紫杉醇及吉西他滨的疗效及安全性的III期KN046-303研究已经达到预设的死亡事件数，总生存期(OS)结果未达到预设的统计学终点。 5月30日，吉利德公布Trop2 ADC治疗晚期尿路上皮癌（mUC）三期临床TROPiCS-04的最新数据，研究没有达到OS主要终点，此外，试验还发现，Trodelvy与更多的早期死亡病例相关，主要由于中性粒细胞减少导致的副作用。吉利德正在进一步分析数据，并将与FDA讨论。六月 6月12日，辉瑞宣布其杜氏肌营养不良症基因疗法PF-06939926治疗杜氏肌营养不良症（DMD）的III期临床CIFFREO失败，与安慰剂相比，PF-06939926在III期试验中未达到主要和关键次要终点。 6月17日，武田公布了其同类首创的强效选择性胆固醇24-羟化酶 (CH24H) 抑制剂Soticlestat (TAK-935)的SKYLINE和SKYWAY研究的顶线数据。SKYWAY (TAK-935-3002)3期研究评估了 Soticlestat 联合标准治疗与安慰剂联合标准治疗对难治性Lennox-Gastaut综合征 (LGS)患者的疗效。与安慰剂相比，Soticlestat未能达到降低严重运动减退性癫痫发作频率的主要终点。 6月17日，Marinus Pharmaceuticals宣布了3期双盲、随机、安慰剂对照RAISE试验（NCT04391569）的初步结果仅达到了两个关键终点中的一个。公司将继续分析RAISE的全部数据集，并计划与美国FDA接触，讨论静脉注射加奈索隆治疗RSE的潜在发展方向。 6月18日，阿斯利康宣布其首创AKT抑制剂Truqap（capivasertib）与紫杉醇联合治疗局部晚期（无法手术）或转移性三阴性乳腺癌（TNBC）患者的CAPItello-290 III期试验未达到双重主要终点，即在整个试验人群或肿瘤携带特定生物标志物改变（PIK3CA、AKT1或PTEN）的亚组患者中，总生存期（OS）与紫杉醇联合安慰剂相比均有所改善。在CAPItello-290中，Truqap与紫杉醇联用的安全性与每种药物的已知安全性基本一致，没有发现新的安全性问题。 6月20日，Jazz制药公布了T型钙通道调节剂suvecaltamide（JZP385）在成人原发性震颤（ET）患者中的IIb期临床试验（NCT05122650）主要结果，与安慰剂相比，30mg suvecaltamide在主要终点（原发性震颤分级评估量表（TETRAS）改良综合结局评分从基线到第12周的变化）和次要终点（临床总体印象-严重程度量表（CGI-S）评分）上，没有达到统计学意义。 6月24日，德国默克宣布终止TrilynX III期随机研究，该研究评估了口服的凋亡抑制蛋白（IAPs）拮抗剂xevinapant联合化放疗（CRT）治疗未切除的局部晚期头颈部鳞状细胞癌（LA SCCHN）患者的效果。该决定是在该研究的独立数据监控委员会进行了预先计划的中期分析后做出的，该委员会认为该试验不太可能达到延长无事件生存期的主要目标。消息发布后，德国默克股价下跌8%。 6月24日，G1 Therapeutics公布了其3期PRESERVE 2试验的最终OS分析结果，该试验评估了CDK4/6抑制剂曲拉西利（trilaciclib）在转移性三阴性乳腺癌（TNBC）患者化疗（吉西他滨和卡铂；GCb）前给药的疗效和安全性，该研究未显示出具有统计学意义的治疗效果。七月 7月4日，罗氏宣布II/III期SKYSCRAPER-06研究未达到主要终点，该研究旨在评估tiragolumab+Tecentriq (atezolizumab)+化疗 vs. pembrolizumab+化疗一线治疗局部晚期不可切除或转移性非鳞状非小细胞肺癌患者。该研究的主要终点无进展生存期（PFS）的风险比（HR）为1. 27（95%CI：1.02,1.57），总生存期（OS）的HR为1.33（95%CI：1.02,1.73）。 7月8日，HilleVax公司公布了NEST-IN1的初步数据结果未达主要终点。受此消息影响，Hillevax当天股价大跌88%。 7月12日，据clinicaltrials.gov网站显示，礼来终止了BTLA单抗LY3361237治疗中度活动型系统性红斑狼疮（SLE）的一项II期研究（NCT05123586），原因为缺乏疗效。 7月18日，AVEO Oncology宣布其口服的下一代血管内皮生长因子受体 (VEGFR) 酪氨酸激酶抑制剂 (TKI) Tivozanib（商品名：Fotivda）联合纳武利尤单抗（O药）二线/三线治疗晚期转移性肾细胞癌（RCC）患者的III期TiNivo-2研究未达到主要终点。试验的主要结果是无进展生存期，次要终点包括总生存期、总缓解率、缓解持续时间和安全性。 7月24日，Sage Therapeutics和Biogen宣布了口服研究药物SAGE-324 (BIIB124)治疗特发性震颤（ET）的KINETIC 2 2期剂量范围研究未达主要终点。SAGE-324是一款在研口服神经活性类固醇（NAS）GABAA 受体正性异位调节剂（PAM）。 7月29日，Ventyx Biosciences宣布，其变构TYK2抑制剂VTX958在中度至重度活动性克罗恩病患者进行的II期研究未达主要终点。Ventyx计划对现有数据进行进一步分析，并且不打算推进额外的临床试验。八月 8月1日，Agios Pharmaceuticals公布了全球3期ACTIVATE-KidsT研究的初步结果未达主要终点，该研究针对1至18岁患有PK缺乏症且定期输血的儿童进行了Pyrukynd (mitapivat)治疗。 8月8日，礼来公司第二季度业绩电话会议上，首席科学官Daniel Skovronsky 透露口服抗 tau 药物LY3372689（一种 O-GlcNAcase (OGA) 抑制剂）在治疗早期症状性阿尔茨海默病的2 期研究中失败。试验组所有剂量与安慰剂相比均未达到首要终点，即预设的综合阿尔茨海默病评定量表 (iADRS) 较基线的变化。 8月21日，LEO Pharma 旗下公司Timber Pharmaceuticals公布了异维A酸外用软膏配方TMB-001治疗中重度先天性鱼鳞病患者的为期12周的3期ASCEND研究结果未达到所有主要和次要终点。与安慰剂相比，对TMB-001治疗有反应的中重度先天性鱼鳞病患者的比例没有统计学意义上的显著差异。 8月29日，Merck宣布终止抗PD-1单抗帕博利珠单抗（Keytruda）两项3期试验 KEYNOTE-867和 KEYNOTE-630。KEYNOTE-867（NCT03924869)研究中，Keytruda联合SBRT与安慰剂联合SBRT相比，在无事件生存期（EFS）或总生存期（OS）（分别为研究的主要终点和关键次要终点）方面均未显示出改善；KEYNOTE-630 (NCT03833167)研究中，Keytruda在主要终点RFS方面未达到统计学显著性。目前该研究的关键次要终点OS尚未正式得出，但已有分析结果显示Keytruda并不优于安慰剂。九月 9月3日，Athira Pharma宣布了其fosgonimeton在轻度至中度阿尔茨海默病 (AD) 患者中的II/III期LIFT-AD临床试验的顶线结果。与安慰剂相比，该试验的主要终点全球统计检验（GST）评分及其关键次要终点ADAS-Cog11和ADCS-ADL23评分在26周时均未达到统计学意义。 9月8日，阿斯利康公布了其抗IL-33单克隆抗体tozorakimab在慢性阻塞性肺病（COPD）的2a期FRONTIER-4研究结果。该研究未能达到改善支气管扩张剂前的用力呼气量（FEV）（即患者用力呼气时所能呼出的空气量）这一主要终点。 9月11日，GSK宣布将停止其单纯疱疹病毒（HSV）疫苗GSK3943104的研发，该疫苗未通过TH HSV REC-003研究，未达有效性主要终点，后续不会进入3期研究。TH HSV REC-003试验是一项联合阶段I/II期概念验证研究，以评估GSK3943104的潜在临床有效性。 9月12日，Neurocrine Biosciences宣布其在研化合物luvadaxistat (NBI-1065844) 的ERUDITE II期临床研究未能达到其作为改善精神分裂症患者认知障碍的潜在治疗方法的主要终点。 9月12日，Fulcrum Therapeutics宣布losmapimod治疗面肩肱型肌营养不良症（FSHD）的III期REACH试验未能达到主要终点。此外，次要终点也没有统计学意义。losmapimod的安全性和耐受性与之前报告的研究结果一致。 9月13日，Atea Pharmaceuticals宣布了评估口服核苷酸聚合酶抑制剂bemnifosbuvir与安慰剂治疗COVID-19的全球III期SUNRISE-3试验未达到主要终点，即在2221名轻度至中度COVID-19高危患者组成的单药治疗队列中，到第29天全因住院或死亡人数的减少具有统计学意义。在SUNRISE-3研究中，bemnifosbuvir总体上安全且耐受性良好。 9月23日，阿斯利康和第一三共共同宣布TROP2 ADC德达博妥单抗（Dato-DXd）二/三线治疗HER2低表达或阴性乳腺癌患者的III期TROPION-Breast01研究未达到总生存期（OS）的主要终点。 9月25日，默沙东宣布，其PD-1抑制剂Keytruda与抗LAG-3抗体favezelimab的联合疗法，在一项针对微卫星稳定（MSS）转移性结直肠癌（mCRC）患者的临床III期试验（KEYFORM-007）中未能显著改善总生存期（OS）。十月 10月8日，Sage Therapeutics宣布其在研NMDA受体正向变构调节剂 Dalzanemdor治疗阿尔茨海默病（AD）的II 期LIGHTWAVE研究未达到主要终点。 10月14日，Transgene公布了其治疗性癌症疫苗Tipapkinogen sovacivec（TG4001）最新的2期临床研究结果，与PD-L1抑制剂阿维鲁单抗（Avelumab）联用治疗HPV16阳性宫颈和肛门生殖器肿瘤未达到主要终点（改善无进展生存期）。 10月22日，Alto Neuroscience发布其在研疗法ALTO-100治疗重度抑郁症（Major depressive disorder）Ⅱb期研究未达到其主要终点。该临床试验结果的公布使得Alto股价在周二晚间的盘后交易中下跌了76%，市值也仅剩1.2亿美金。 10月29日，Spero Therapeutics宣布其在研非结核分枝杆菌肺病小分子治疗药物候选抗生素SPR720（Fobrepodacin）的Ⅱa期研究的中期分析未达到主要终点。公司暂停该项目，内部重组裁员约39%。十一月 11月12日，Syros Pharmaceuticals公司宣布，tamibarotene治疗新诊断RARA基因过表达高危骨髓增生异常综合征患者的III期临床SELECT-MDS-1未能达到主要终点，与对照组相比，Tamibarotene+Azacitidine联合疗法未能显著提高某些MDS患者的完全缓解率。 11月12日，艾伯维宣布其用于治疗精神分裂症的M4激动剂Emraclidine在两项名为EMPOWER-1和EMPOWER-2的临床二期试验中，未达到其主要终点。受此消息的影响，艾伯维股价大跌超12%，市值蒸发约400亿美元。 11月15日，眼科公司Eyenovia宣布验证MicroPine（阿托品局部微量制剂）延缓儿童近视进展效果的III期CHAPERONE研究未达到主要终点（3年内视力进展低于0.5屈光度）。Eyenovia计划终止这项研究，更彻底地审查数据，并评估下一步工作。受此消息影响，Eyenovia股价下跌了70%。 11月24日，天士力医药集团股份有限公司宣布：因临床试验结果不达预期，其间接控股子公司赛远生物安美木单抗项目临床试验暂停，目前该试验处于II期临床阶段，并对开发支出余额1.62亿元全额计提资产减值准备。 11月25日，Cassava Sciences宣布Simufilam治疗轻度至中度阿尔茨海默病（AD）的III期ReThink-ALZ研究未达到预先指定的双重主要终点以及次要终点和探索性生物标志物终点。受此消息影响，Cassava Sciences的股价当日下跌了84%。 2024年11月26日，罗氏宣布其TIGIT抗体tiragolumab在3期 SKYSCRAPER-01研究中的最新进展，该研究评估了Tiragolumab联合 Tecentriq与单独使用Tecentriq对 PD-L1 高表达、局部晚期或转移性非小细胞肺癌 (NSCLC) 患者的疗效，该研究在最终分析时没有达到总生存率的主要终点。十二月 12月3日，Roivant 旗下Kinevant Sciences 公司公告其核心资产namilumab用于结节病的中期临床试验失败，将终止开发。该研究主要终点和次要终点均没有达到。 12月4日，Relmada Therapeutics报告称REL-1017治疗重度抑郁症的3期 Reliance II 试验不太可能达到疗效目标。公司将重新评估数据，同时继续推进治疗代谢性疾病的 REL-P11项目。 12月7日，微芯生物公告其在研新药西奥罗尼胶囊单药治疗三线及以上小细胞肺癌Ⅲ期临床试验结果，在经过广泛抗肿瘤免疫治疗后的总体人群中，虽然西奥罗尼中位PFS（无进展生存期）显著延长，降低疾病进展风险70%以上，但在另一主要终点mOS（中位总生存期）上，与安慰剂组相比不具显著差异。 12月11日，Corcept Therapeutics发布了Dazucorilant治疗肌萎缩侧索硬化症（ALS）2期临床试验DAZALS的研究结果。DAZALS未达到其主要终点，即与接受安慰剂的患者相比，接受Dazucorilant治疗的患者在ALS功能评分量表-修订版（ALSFRS-R）中的变化。 2024年12月16日，UCB宣布，与诺华合作开发的 minzasolmin（一种研究性口服小分子 α-突触核蛋白错误折叠抑制剂）的 ORCHESTRA 帕金森病概念验证研究未达到其主要和次要临床终点。 12月19日，罗氏宣布了IIb期PADOVA研究的结果，该临床研究α-突触核蛋白（α-Syn）单抗 prasinezumab 在586名早期帕金森病患者中的疗效，这些患者接受了至少18个月的稳定症状治疗。Prasinezumab 在主要终点“确认运动进展时间”方面显示出潜在的临床疗效，HR=0.84 [0.69-1.01]，p=0.0657，未达到统计学显著性。 2024年12月20日，Galectin Therapeutics 宣布其代谢功能障碍相关脂肪性肝炎（MASH）新药Belapectin的III期NAVIGATE研究顶线结果。结果显示，试验组未显示出具有统计学意义的临床获益，未达主要终点。总结 2024年失败的临床研究中，53个为III期研究，27个为II期研究，8个为IIb期研究，5个为I/II期研究，5个为II/III期研究，4个为IIa期研究，2个为I期研究，1个为I/IIb期研究，1个为II/IIb期研究，1个为IV期研究。由此可见III期临床研究失败率最高，特别是在肿瘤领域，由于药物的特殊性以及对疗效和安全性的严格要求，III期临床研究的失败率可能会更高。例如，有数据显示在III期临床开发与监管申请递交之间，肿瘤临床研究的失败率为48%，明显高于非肿瘤临床研究的29%。导致III期临床研究失败的原因多种多样，主要包括无法达到预期的疗效终点、严重的不良反应事件、疗效不佳等，基础研究不足、临床研究设计缺陷、剂量选择不当、数据收集和分析问题以及操作执行问题等，也可能导致III期临床研究失败。即使临床试验失利的消息频传，实际上能够挺进临床环节的分子已是百里挑一。我们仍要保持积极态度看待，毕竟新药研发之路处处存在反转，只要一息尚存，就有赢的可能。参考资料：各公司公告

临床3期抗体药物偶联物临床结果免疫疗法临床2期

2024-11-06

·GlobeNewswire-Health Care

Allakos Provides Business Update and Reports Third Quarter 2024 Financial Results

SAN CARLOS, Calif., Nov. 06, 2024 (GLOBE NEWSWIRE) -- Allakos Inc. (the “Company”) (Nasdaq: ALLK), a biotechnology company developing antibodies for the treatment of allergic, inflammatory and proliferative diseases, today provided a business update and reported financial results for the third quarter ended September 30, 2024. Recent Allakos Events Reported safety, pharmacokinetics (PK), and pharmacodynamic (PD) results from the Phase 1 trial of subcutaneous (SC) AK006 in healthy volunteers. Bioavailability of subcutaneous AK006 was approximately 77%.Subcutaneous administered AK006 showed an estimated half-life of 12-22 days.Consistent with the IV formulation, skin biopsies taken from subcutaneous AK006 treated healthy volunteers showed high levels of receptor occupancy confirming AK006 reaches skin tissue mast cells.The 720 mg dose of AK006 showed 98% receptor occupancy at day 113 suggesting the potential for infrequent dosing.Single and multiple doses of IV AK006 and single dose subcutaneous AK006 up to 720 mg were well tolerated with a favorable safety profile. Completed enrollment of over 30 patients in the randomized, double-blind, placebo-controlled Phase 1 trial of intravenous (IV) AK006 in patients with chronic spontaneous urticaria. Data from these patients expected in early Q1 of 2025. Upcoming Allakos Anticipated Milestones Report randomized double-blind, placebo-controlled data on over 30 patients from the Phase 1 trial of AK006 in patients with CSU in early Q1 of 2025. Cash Guidance Allakos ended the third quarter of 2024 with $92.7 million in cash, cash equivalents and investments. Allakos’ financial outlook, restructuring activities and estimated cash runway as reported by the Company in January 2024 remain unchanged. The Company reiterates that it expects the restructuring activities will extend the cash runway into mid-2026 and to end 2024 with total cash, cash equivalents and investments in its previously stated $81 to $86 million guidance range. The Company has substantially completed its exit of the lirentelimab development program. Third Quarter 2024 Financial Results Allakos ended the third quarter of 2024 with $92.7 million in cash, cash equivalents and investments resulting in a net decrease in cash, cash equivalents and investments of $30.4 million during the third quarter of 2024. Approximately $18 million of this third quarter decrease was paid in connection with exiting the lirentelimab development program. Research and development expenses were $10.9 million in the third quarter of 2024 compared to $36.7 million in the third quarter of 2023, a decrease of $25.8 million. This quarter over quarter decrease is attributed to $16.4 million of lower contract research and development costs, primarily due to halting lirentelimab development and includes a $4.6 million decrease relating to a change in estimated manufacturing costs upon resolution of the related work orders with the vendor, $5.7 million of decreased compensation costs and a $3.7 million decrease in other research and development expenses. General and administrative expenses were $8.9 million for the third quarter of 2024 compared to $11.5 million for the third quarter of 2023, a decrease of $2.6 million. The quarter over quarter change included $2.4 million of decreased compensation costs and $0.2 million of decreased other general and administrative expenses. Allakos reported a net loss of $18.4 million in the third quarter of 2024 compared to $45.6 million in the third quarter of 2023. Net loss per basic and diluted share was $0.21 for the third quarter of 2024 compared to $0.52 in the third quarter of 2023. About Allakos Allakos is a clinical stage biotechnology company developing therapeutics that target immunomodulatory receptors present on immune effector cells involved in allergy, inflammatory and proliferative diseases. Activating these immunomodulatory receptors allows for the direct targeting of cells involved in disease pathogenesis and, in the setting of allergy and inflammation, has the potential to result in broad inhibition of inflammatory cells. The Company’s most advanced product candidate is AK006. AK006 targets Siglec-6, an inhibitory receptor expressed on mast cells. Mast cells are widely distributed in the body and play a central role in the inflammatory response. Inappropriately activated mast cells have been identified as key drivers in a number of severe diseases affecting the gastrointestinal tract, eyes, skin, lungs and other organs. In preclinical studies, AK006 appears to provide deep mast cell inhibition and, in addition to its inhibitory activity, reduce mast cell numbers. For more information, please visit the Company’s website at www.allakos.com. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 as contained in Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Such forward-looking statements include, but are not limited to, Allakos’ expected timing of reporting data from its clinical trial of AK006; cash guidance and runway; and restructuring. Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially from current expectations and beliefs, including but not limited to: Allakos’ stages of clinical drug development; Allakos’ ability to timely initiate and complete clinical trials for AK006; Allakos’ ability to obtain required regulatory approvals for its clinical trials; uncertainties related to the enrollment of patients in its clinical trials; Allakos’ ability to demonstrate sufficient safety and efficacy of its product candidates in its clinical trials; uncertainties related to the success of clinical trials, regardless of the outcomes of preclinical testing or early-stage trials; Allakos’ ability to obtain regulatory approvals to market its product candidates; market acceptance of Allakos’ product candidates; uncertainties related to the projections of the size of patient populations suffering from the diseases Allakos is targeting; Allakos’ ability to advance additional product candidates beyond AK006; uncertainties related to Allakos’ ability to realize the contemplated benefits of its restructuring and related reduction in force; Allakos’ ability to accurately forecast financial results; Allakos’ ability to obtain additional capital to finance its operations, research and drug development; Allakos’ ability to maintain the listing of our common stock on Nasdaq; general economic and market conditions, both domestic and international; domestic and international regulatory obligations; and other risks. Information regarding the foregoing and additional risks may be found in the section entitled “Risk Factors” in documents that Allakos files from time to time to with the SEC. These documents contain and identify important factors that could cause the actual results for Allakos to differ materially from those contained in Allakos’ forward-looking statements. Any forward-looking statements contained in this press release speak only as of the date hereof, and Allakos specifically disclaims any obligation to update any forward-looking statement, except as required by law. These forward-looking statements should not be relied upon as representing Allakos’ views as of any date subsequent to the date of this press release. Source: Allakos Inc. Investor Contact:Adam Tomasi, PresidentAlex Schwartz, VP Strategic Finance and Investor Relationsir@allakos.com Media Contact:media@allakos.com ALLAKOS INC.UNAUDITED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS(in thousands, except per share data) Three Months Ended Nine Months Ended September 30, September 30, 2024 2023 2024 2023 Operating expenses Research and development $10,874 $36,749 $65,120 $97,107 General and administrative 8,876 11,461 28,985 33,966 Impairment of long-lived assets — — 27,347 — Total operating expenses 19,750 48,210 121,452 131,073 Loss from operations (19,750) (48,210) (121,452) (131,073)Interest income 1,392 2,590 5,346 7,965 Other expense, net (14) (6) (88) (42)Net loss (18,372) (45,626) (116,194) (123,150)Unrealized gain (loss) on investments 325 87 284 212 Comprehensive loss $(18,047) $(45,539) $(115,910) $(122,938)Net loss per common share: Basic and diluted $(0.21) $(0.52) $(1.31) $(1.42)Weighted-average number of commonshares outstanding: Basic and diluted 89,024 87,115 88,571 86,539 ALLAKOS INC.UNAUDITED CONDENSED BALANCE SHEETS(in thousands) September 30, December 31, 2024 2023 Assets Current assets: Cash and cash equivalents $10,449 $66,440 Investments 82,266 104,354 Prepaid expenses and other current assets 4,438 9,095 Total current assets 97,153 179,889 Property and equipment, net 15,733 33,369 Operating lease right-of-use assets 9,880 24,136 Other long-term assets 1,668 6,216 Total assets $124,434 $243,610 Liabilities and stockholders’ equity Current liabilities: Accounts payable $3,964 $1,764 Accrued expenses and other current liabilities 12,017 34,814 Total current liabilities 15,981 36,578 Operating lease liabilities, net of current portion 35,710 38,215 Total liabilities 51,691 74,793 Stockholders’ equity: Common stock 89 88 Additional paid-in capital 1,306,991 1,287,156 Accumulated other comprehensive gain (loss) 334 50 Accumulated deficit (1,234,671) (1,118,477) Total stockholders’ equity 72,743 168,817 Total liabilities and stockholders’ equity $124,434 $243,610

财报临床1期临床结果

100 项与 Antolimab 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	Antolimab	-	-

研发状态

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适应症	最高研发状态	国家/地区	公司	日期
嗜酸粒细胞性食管炎	临床3期	美国	Allakos, Inc.	2020-07-06
嗜酸粒细胞性食管炎	临床3期	澳大利亚	Allakos, Inc.	2020-07-06
嗜酸粒细胞性食管炎	临床3期	荷兰	Allakos, Inc.	2020-07-06
嗜酸性粒细胞性十二指肠炎	临床3期	美国	Allakos, Inc.	2020-06-18
嗜酸粒细胞性胃肠炎	临床3期	美国	Allakos, Inc.	2020-06-18
中度特应性皮炎	临床2期	美国	Allakos, Inc.	2022-06-27
中度特应性皮炎	临床2期	德国	Allakos, Inc.	2022-06-27
重度特应性皮炎	临床2期	美国	Allakos, Inc.	2022-06-27
重度特应性皮炎	临床2期	德国	Allakos, Inc.	2022-06-27
慢性荨麻疹	临床2期	美国	Allakos, Inc.	2018-01-23

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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


NCT05528861 (MAVERICK, CTgov)	临床2期	慢性荨麻疹	127	AK002 (AK002 SC 300 mg (Main Study))	窪製廠壓蓋鹽鏇淵淵顧(壓淵鏇鑰築襯繭製顧繭) = 鹹製糧醖壓醖窪壓簾繭夢膚壓蓋鹽鏇艱鏇艱壓 (醖憲鹹顧觸膚鏇壓遞鹽, 1.9) 更多	-	2024-09-27
				Placebo (Placebo (Main Study))	窪製廠壓蓋鹽鏇淵淵顧(壓淵鏇鑰築襯繭製顧繭) = 衊襯夢廠窪構醖窪蓋鑰夢膚壓蓋鹽鏇艱鏇艱壓 (醖憲鹹顧觸膚鏇壓遞鹽, 2.0) 更多
NCT05155085 (ATLAS, CTgov)	临床2期	中度特应性皮炎 \| 重度特应性皮炎	131	AK002 (AK002 SC 300 mg (Main Study))	鑰選遞鑰顧鹽襯積齋夢 = 襯糧糧願構襯願鏇醖積餘鏇顧簾積艱製襯夢夢 (簾壓鏇構遞鬱憲積鹹範, 夢夢鹽鹽簾膚衊齋觸築 ~ 簾網鬱觸繭壓餘膚願餘) 更多	-	2024-09-24
				Placebo (Placebo (Main Study))	鑰選遞鑰顧鹽襯積齋夢 = 衊鏇願膚蓋糧鑰壓網鏇餘鏇顧簾積艱製襯夢夢 (簾壓鏇構遞鬱憲積鹹範, 願窪築繭糧鏇簾獵選餘 ~ 顧夢構選繭鑰鏇鑰積艱) 更多
NCT04620811 (CTgov)	临床3期	嗜酸粒细胞性胃肠炎 \| 嗜酸性粒细胞性十二指肠炎	159	Lirentelimab (AK002) (Main Study Placebo to Extension Study 3.0 mg/kg of Lirentelimab (AK002))	醖衊簾蓋獵築齋鏇獵網 = 繭齋範淵網窪鹹網選醖鏇製醖醖網網網壓膚膚 (鬱觸憲製範餘鬱蓋願鹹, 襯淵齋淵獵糧襯製糧鏇 ~ 鏇廠膚簾積窪醖網糧淵) 更多	-	2024-04-18
				Lirentelimab (Main Study Active to Extension Study 3.0 mg/kg of Lirentelimab (AK002))	醖衊簾蓋獵築齋鏇獵網 = 築糧鏇淵顧製繭簾網選鏇製醖醖網網網壓膚膚 (鬱觸憲製範餘鬱蓋願鹹, 壓顧範壓襯鬱簾構蓋願 ~ 構壓積遞簾鹽築醖構壓) 更多
NCT03664960 (CTgov)	临床2期	嗜酸粒细胞性胃肠炎 \| 嗜酸性粒细胞性十二指肠炎	58	Placebo+AK002 (Main Study Placebo to Extension Study 1 to 3.0 mg/kg of AK002)	醖壓積鏇獵遞壓簾餘壓 = 願餘窪糧齋觸艱窪遞壓鏇齋網鹽壓壓鹽構築鑰 (積積範鏇積鏇願夢艱築, 選網鬱鏇築鹹遞選遞淵 ~ 壓鹹鬱繭觸顧膚鏇艱壓) 更多	-	2024-02-28
				AK002 (Main Study Active to Extension Study 1 to 3.0 mg/kg of AK002)	醖壓積鏇獵遞壓簾餘壓 = 遞襯願築壓鹽淵鹽鹹蓋鏇齋網鹽壓壓鹽構築鑰 (積積範鏇積鏇願夢艱築, 鹹糧齋顧鏇齋鹹夢膚網 ~ 觸糧範選齋積鑰鬱鹹積) 更多
NCT03496571 (ENIGMA, CTgov)	临床2期	嗜酸粒细胞性胃肠炎	65	AK002 (1 mg/kg of AK002)	繭繭鹽製積簾獵築選顧(構範繭願觸鑰艱淵鏇窪) = 獵獵選襯願壓膚願襯網鬱糧鬱選構窪網鏇憲遞 (簾齋顧襯餘範衊憲築繭, 衊網蓋廠網範蓋鬱廠壓 ~ 鬱遞製齋齋範簾餘顧蓋) 更多	-	2024-01-17
				AK002 (3 mg/kg of AK002)	繭繭鹽製積簾獵築選顧(構範繭願觸鑰艱淵鏇窪) = 鬱鏇餘壓鏇積遞壓蓋觸鬱糧鬱選構窪網鏇憲遞 (簾齋顧襯餘範衊憲築繭, 鑰積窪廠蓋壓獵淵餘蓋 ~ 壓淵淵艱製衊憲廠顧齋) 更多
NCT05155085 (ATLAS, GlobeNewswire) 人工标引	临床2期	特应性皮炎	122	Lirentelimab	餘願鹽衊築築糧網艱壓(遞簾鬱糧夢鑰蓋範餘夢) = 衊襯鏇窪鏇觸鑰簾廠壓夢顧餘範廠構鑰繭鏇夢 (壓壓積糧鬱獵蓋積齋觸 ) 未达到更多	不佳	2024-01-16
				Placebo	餘願鹽衊築築糧網艱壓(遞簾鬱糧夢鑰蓋範餘夢) = 蓋壓糧齋獵簾願鹽醖憲夢顧餘範廠構鑰繭鏇夢 (壓壓積糧鬱獵蓋積齋觸 ) 未达到更多
NCT05528861 (MAVERICK, GlobeNewswire) 人工标引	临床2期	慢性荨麻疹	123	Lirentelimab	壓顧鹹醖膚夢製製夢觸(淵簾鬱膚遞糧繭簾願膚) = 淵獵餘鑰糧範願繭範窪鏇簾築鹽遞憲壓繭鹹鏇 (網壓鏇簾簾膚淵壓選廠 ) 更多	不佳	2024-01-16
				Placebo	壓顧鹹醖膚夢製製夢觸(淵簾鬱膚遞糧繭簾願膚) = 鹽顧繭繭醖觸積夢糧艱鏇簾築鹽遞憲壓繭鹹鏇 (網壓鏇簾簾膚淵壓選廠 ) 更多
NCT04322604 (ENIGMA 2, CTgov)	临床3期	嗜酸粒细胞性胃肠炎 \| 嗜酸性粒细胞性十二指肠炎	181	lirentelimab (AK002) (3 mg/kg of Lirentelimab (AK002))	網蓋網膚鏇窪鏇積窪膚 = 壓鬱齋淵繭淵糧壓艱膚網獵鑰膚夢觸積獵膚鹹 (繭淵顧網繭製艱鑰鑰顧, 遞選鏇膚廠醖鹽選糧積 ~ 鏇齋觸膚製網淵繭淵網) 更多	-	2024-01-02
				Placebo (Placebo)	網蓋網膚鏇窪鏇積窪膚 = 選積顧鏇蓋網築觸製窪網獵鑰膚夢觸積獵膚鹹 (繭淵顧網繭製艱鑰鑰顧, 齋艱艱範鹹遞淵顧餘鑰 ~ 鹽鏇鹹繭襯憲襯積遞鬱) 更多
NCT04856891 (EoDyssey, CTgov)	临床3期	嗜酸粒细胞性胃肠炎 \| 嗜酸性粒细胞性十二指肠炎	94	AK002 (3.0 mg/kg of Lirentelimab (AK002))	膚醖艱夢鏇簾構膚獵觸 = 糧蓋願蓋艱夢糧選鬱築製憲遞構鏇壓艱鏇憲齋 (憲鹹壓遞襯鑰鬱廠憲廠, 衊醖蓋簾齋顧衊鹹觸鏇 ~ 遞襯網蓋襯蓋鹽蓋遞築) 更多	-	2024-01-02
				Placebo (Placebo)	膚醖艱夢鏇簾構膚獵觸 = 廠鹹鹽顧衊糧願膚壓憲製憲遞構鏇壓艱鏇憲齋 (憲鹹壓遞襯鑰鬱廠憲廠, 繭觸壓選醖鏇膚鬱襯鏇 ~ 齋膚鏇窪顧構網觸醖餘) 更多
NCT04322708 (KRYPTOS, CTgov)	临床2/3期	嗜酸粒细胞性食管炎	277	lirentelimab (AK002) (1 mg/kg of Lirentelimab (AK002))	壓遞淵鬱願醖鑰齋齋蓋 = 壓鬱觸襯餘壓構夢夢襯鑰觸繭憲鬱襯築憲廠鏇 (蓋築觸繭鏇選繭簾憲淵, 鏇淵製壓夢鏇顧繭積窪 ~ 餘簾醖築餘構鹹齋繭糧) 更多	-	2024-01-02
				lirentelimab (AK002) (3 mg/kg of Lirentelimab (AK002))	壓遞淵鬱願醖鑰齋齋蓋 = 遞蓋餘壓夢糧壓鏇觸淵鑰觸繭憲鬱襯築憲廠鏇 (蓋築觸繭鏇選繭簾憲淵, 鏇廠鹹醖顧糧製築糧鹹 ~ 構淵憲襯壓齋鬱繭窪築) 更多