A Three-year, Multi-center, Double-blind, Extension Study to Evaluate the Long-term Safety and Efficacy of Ligelizumab in Patients Who Completed Ligelizumab's Phase III Studies in Food Allergy

This is an extension study to evaluate the long-term safety and efficacy of ligelizumab in participants who have completed a ligelizumab Phase III study in food allergy.

开始日期2022-08-27

申办/合作机构

Novartis Pharmaceuticals Corp.

NCT04984876 / Terminated临床3期

A 52 Week, Multi-center, Randomized, Double-blind Placebo-controlled Study to Assess the Clinical Efficacy and Safety of Ligelizumab (QGE031) in Decreasing the Sensitivity to Peanuts in Patients With Peanut Allergy

This was a 52-week, Phase 3 multi-center, randomized, double-blind and placebo-controlled study to assess the safety and clinical efficacy of two dosing regimens of ligelizumab (240 mg and 120 mg) SC q4w (subcutaneous injection every 4 weeks) in participants with a medically confirmed diagnosis of Immunoglobulin E (IgE) mediated peanut allergy.

开始日期2021-12-07

申办/合作机构

Novartis Pharmaceuticals Corp.

NCT05024058 / Terminated临床3期

A Multi-center, Randomized, Double-blind, Placebo Controlled Study to Investigate the Efficacy and Safety of Ligelizumab (QGE031) in the Treatment of Chronic Inducible Urticaria (CINDU) in Adolescents and Adults Inadequately Controlled With H1-antihistamines

This was a placebo controlled, phase 3 study designed to evaluate the efficacy and safety of ligelizumab in participants with chronic inducible urticaria who are inadequately controlled with H1-antihistamines

开始日期2021-11-16

申办/合作机构

Novartis Pharmaceuticals Corp.

100 项与 Ligelizumab 相关的临床结果

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100 项与 Ligelizumab 相关的转化医学

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100 项与 Ligelizumab 相关的专利（医药）

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项与 Ligelizumab 相关的文献（医药）

2024-10-01·EUROPEAN JOURNAL OF CLINICAL PHARMACOLOGY

Time-course and dose-effect of omalizumab in treating chronic idiopathic urticaria/chronic spontaneous urticaria

Article

作者: Ye, Kaihe ; Zhang, Ke ; Zhao, Aiping ; Zhu, Guanghu ; Xu, Zhaosi ; Wang, Zhen ; Gong, Xiao

PURPOSE:

Several studies have shown that subcutaneous injections of omalizumab can treat chronic idiopathic/spontaneous urticaria (CIU/CSU) patients by only assessing the efficacy on specific endpoints. This study aimed to quantitatively analyze different doses of omalizumab in CIU/CSU and compare it with ligelizumab.

METHODS:

Literature searches were performed in PubMed, Embase, and Web of Science databases. A model-based meta-analysis (MBMA) was utilized to develop a model incorporating time since the initiation of treatment and dose for omalizumab, with the change from baseline in Urticaria Activity Score (CFB-UAS7) as the primary efficacy endpoint. The time-course and dose-effect relationship throughout the omalizumab treatment period was analyzed, and the findings were compared with those of the investigational ligelizumab.

RESULTS:

The model equation for the CFB-UAS7 was established as E = -E_max × time/(ET₅₀ + time) × (b₀ + b₁ × dose). The estimated values of the model parameters __-mml:math xmlns:mml="http://www.w3.org/1998/Math/MathML"-__E max , __-mml:math xmlns:mml="http://www.w3.org/1998/Math/MathML"-__ ET 50 , __-mml:math xmlns:mml="http://www.w3.org/1998/Math/MathML"-__b 0 , and __-mml:math xmlns:mml="http://www.w3.org/1998/Math/MathML"-__b 1 were -1.16, 1.26 weeks, -9.90, and -0.0361 mg^-1, respectively. At week 12 after the first dose, the model-predicted CFB-UAS7 for 150 mg and 300 mg of omalizumab were -16.0 (95% CI, -17.2 to -14.8) and -21.7 (95% CI, -22.9 to -20.5), respectively. In the PEARL-1 trial, the CFB-UAS7 for 72 mg and 120 mg of ligelizumab were -19.4 (95% CI, -20.7 to -18.1) and -19.3 (95% CI, -20.6 to -18.0), respectively. In the PEARL-2 trial, these values were -19.2 (95% CI, -20.5 to -17.9) and -20.3 (95% CI, -21.6 to -19.0), respectively.

CONCLUSION:

Omalizumab showed a significant dose-dependent effect in the treatment of CSU. Both 72 mg and 120 mg ligelizumab might have the potential to outperform 150 mg (but not 300 mg) omalizumab.

2024-09-01·ALLERGOLOGY INTERNATIONAL

Long term safety and efficacy of ligelizumab in the treatment of Japanese patients with chronic spontaneous urticaria

Article

作者: Ichishita, Ryohei ; Takahashi, Hidetoshi ; Severin, Thomas ; Fukunaga, Atsushi ; Burciu, Alis ; Hide, Michihiro ; Varanasi, Vineeth ; Tomimatsu, Naoko ; Hayama, Koremasa ; Fujishige, Ayako ; Hua, Eva ; Sasajima, Takayoshi

BACKGROUND:

In Japan, urticaria is a common skin disorder with chronic spontaneous urticaria (CSU) being the most frequent subtype. This study evaluated the safety of ligelizumab (anti-IgE monoclonal antibody) in Japanese CSU patients.

METHODS:

This was a Phase 3 multicenter, open-label, single-arm 52-week study in adult Japanese patients with CSU inadequately controlled with locally approved doses of H1-antihistamines. The primary objective reported the safety of ligelizumab 120 mg subcutaneously every 4 weeks, by evaluation of treatment emergent adverse events (TEAE). Secondary objectives evaluated efficacy by absolute change from baseline (CFB) in weekly urticaria activity score (UAS7), and the proportion of patients with UAS7 = 0, and dermatology life quality index (DLQI) = 0-1 over time.

RESULTS:

From a total of 66 CSU patients (80.3% females; mean ± SD age 46.4 ± 13.2 years; mean ± SD baseline UAS7 28.7 ± 6.5) enrolled, 53 patients (80.3%) reported ≥1 TEAE during the study, with no severe or serious adverse events, no anaphylaxis events and low frequency of TEAEs leading to treatment discontinuations (6.1%). Absolute mean CFB of UAS7 showed a rapid onset of response at Week 4 (-14.2) with further improvement until end of treatment at Week 52 (-22.9). The proportion of patients achieving UAS7 = 0 improved over time (14.5% at Week 4; 50.0% at Week 52). A sizable proportion of patients achieved DLQI 0-1 with the first dose of ligelizumab (38.5%), and improvements observed throughout the study until Week 52 (68.8%).

CONCLUSIONS:

Treatment with ligelizumab 120 mg was well-tolerated with mild to moderate adverse events and was efficacious in Japanese patients.

2024-06-01·Current opinion in allergy and clinical immunology

Role of biologics in severe food allergy

Review

作者: Cafarotti, Arianna ; Dinardo, Giulio ; Miraglia del Giudice, Michele ; Fiocchi, Alessandro ; Artesani, Maria Cristina ; Fierro, Vincenzo ; Indolfi, Cristiana

Purpose of review:

This review examine the dynamic landscape of food allergy treatment within the context of emerging biologics. Our purpose is to comprehensively evaluate the potential benefits, challenges, and transformative impact associated with the utilization of biologics in comparison to conventional therapeutic modalities.

Recent findings:

This document synthesizes recent scientific investigations to various biologics, such as omalizumab, ligelizumab, dupilumab, and tezepelumab, providing a nuanced understanding of their roles in oral immunotherapy, rapid desensitization, and overall food allergy management. Recent studies and clinical trials highlight the impact of anti-IgE treatment on food allergies, revealing critical findings such as dose-related efficacy, facilitation of rapid desensitization in peanut allergies, and the sustained positive outcomes observed in individuals with multifood allergies.

Summary:

The use of biologics presents a groundbreaking approach in the treatment of food allergies. The multifaceted action of these agents, along with their potential to overcome the challenges associated with traditional therapies, marks a significant advancement. Despite the persisting challenges of economic constraints and the need for further safety studies, biologics offer a promising avenue for improving the quality of life for individuals with food allergies. Ongoing research and collaborative efforts are imperative to fully realize the transformative potential inherent in these emerging therapeutic frontiers.

项与 Ligelizumab 相关的新闻（医药）

2024-10-08

·生物制品圈

石药集团「奥马珠单抗」生物类似药获批上市

今日（10月8日），中国国家药监局（NMPA）官网最新公示，石药集团以注册分类3.3类申报的注射用奥马珠单抗生物类似药上市申请已获得上市批准。根据石药集团早先新闻稿，该产品是人免疫球蛋白E（IgE）人源化单克隆抗体，适用于H1抗组胺药治疗后仍有症状的成人和青少年（12岁及以上）慢性自发性荨麻疹患者。截图来源：NMPA官网慢性自发性荨麻疹（CSU）是慢性荨麻疹中最常见的类型，其特征为在无特定外部触发因素的情况下发生瘙痒性荨麻疹、血管性水肿或两者均持续超过6周。CSU相关症状将对日常活动和睡眠产生不利影响，并对整体生活质量产生潜在负面影响。该疾病的潜在发病机制虽然尚不完全清楚，但涉及自身过敏原IgE与皮肤肥大细胞表面高亲和力IgE受体FcɛRI的交联及随后的脱颗粒。这导致组胺和促炎介质释放，引起CSU体征和症状[2]。作为一款IgE人源化单克隆抗体，奥马珠单抗可通过降低游离IgE水平、下调高亲和力IgE受体和限制肥大细胞的脱颗粒化，减少过敏性炎症级联反应中多种介导因子的释放；它还能降低IgE介导的哮喘患者的哮喘加重率。奥马珠单抗原研产品已在中国获批用于治疗过敏性哮喘、慢性自发性荨麻疹等适应症。 2019年，石药集团与兴盟生物订立协议，获得后者授出奥马珠单抗生物类似药SYN008的独家权利。根据石药集团早先新闻稿介绍，该公司奥马珠单抗生物类似药遵循生物类似药相关研究指南，通过药学、非临床、临床药代动力学、临床有效性及安全性等一系列递进研究，确证了其与原研产品在质量、安全性和有效性方面高度相似，无临床意义上的差异。参考资料： [1] 2024年10月08日药品批准证明文件送达信息. Retrieved Oct 08, 2024, from https://www.nmpa.gov.cn/zwfw/sdxx/sdxxyp/yppjfb/20241008142557142.html [2] Maurer M, Ensina LF, Gimenez-Arnau AM, et al. (2024) Efficacy and safety of ligelizumab in adults and adolescents with chronic spontaneous urticaria: results of two phase 3 randomised controlled trials. Lancet. https://pubmed.ncbi.nlm.nih.gov/38008109/ [3] 石药集团奥马珠单抗上市申请获受理 . Retrieved Jun 26, 2023, from https://mp.weixin.qq.com/s/wVdiI9tZXUg-ZgIJ9JXQZQ

生物类似药上市批准

2024-07-14

·医药魔方

2024年6月 | 12款创新药进入III期，5款来自中国药企

根据全球临床试验收录网站clinicaltrials和中国临床试验登记平台chinadrugtrials，6月共12款创新药进入III期阶段，其中5款来自中国药企。这些在研药物覆盖靶点不乏HER2、PI3K、c-Kit等成熟靶点，也包括TIGIT、SIRPα、MDM2这类还未出现突破性进展的靶点。本文筛选其中9款重点产品加以介绍。注：1.信息来源于Clinicaltrials和Chinadrugtrials。 2.仅登记创新药，微创新和生物类似药不包括在内。 3.同一款药物在同一天启动多项III期临床，适应症合并记录；同一款药物在一个月内启动多项III期临床，以最早登记者准。 4.URAT1：尿酸转运蛋白1；SIRPα：信号调节蛋白α；PI3Kα：磷酸肌醇-3-激酶α；CK1ε：酪蛋白激酶1ε；OX2R：食欲素受体2；GABRA2：γ-氨基丁酸受体α2亚基；PSD95：突触后密度蛋白95；nNOS：神经元型一氧化氮合酶；MDM2：鼠双微粒体2。药物：IMM01 靶点：SIRPα 适应症：霍奇金淋巴瘤 IMM01（替达派西普）为宜明昂科自主研发的一款SIRPα-Fc融合蛋白，具有双重机制，能够同时阻断来自肿瘤的“别吃我”信号，并通过IgG1激活患者免疫系统的“吃我”信号。替达派西普在体内具有强大的抗肿瘤活性，临床上可以观察到单药的有效性。同时，在临床前体内药效试验中，替达派西普与靶向药物或免疫治疗药物联用，显示了针对血液肿瘤还有实体瘤的强大的抑瘤活性。 II期IMM01-04研究结果显示，33例既往接受PD-(L)1抗体治疗失败后的经典型霍奇金淋巴瘤（cHL）患者接受替达派西普联合替雷利珠单抗治疗后，客观缓解率（ORR）为65.6%（21/32），实现完全缓解（CR）的患者比例为18.8%（6/32），疾病控制率（DCR）达到了93.8%（30/32）。而且各个亚组分析的结果均显示，患者可以从联合治疗中获益。另外，替达派西普联合替雷利珠单抗治疗耐受性良好，没有患者发生因药物相关不良反应导致的永久停药情况。替达派西普于2019年8月进入I期临床阶段。截至目前，宜明昂科就该药物已申请了3项III期临床试验，分别针对经治cHL、初治骨髓增生异常综合征（MDS）、初治慢性粒-单核细胞白血病（CMML）。目前，全球共24款临床在研SIRPα靶向药物，其中替达派西普和evorpacept（ALX Oncology）是进展较快的两款产品。evorpacept也是一款SIRPα-Fc融合蛋白。 2022年1月，evorpacept联合曲妥珠单抗、雷莫西尤单抗和紫杉醇对比曲妥珠单抗联合雷莫西尤单抗和紫杉醇二线治疗HER2+胃癌患者的II/III期ASPEN-06研究启动。该研究的II期部分结果已于2023年10月公布。结果显示，evorpacept组患者经确认的总缓解率（ORR）为52%，而对照组这一数值为22%。此外，evorpacept组患者的中位缓解持续时间（mDOR）尚未达到，而对照组这一数字为7.4个月。药物：HZ-H08905 靶点：PI3Kα/CK1ε 适应症：外周T细胞淋巴瘤 HZ-H08905是和正医药开发的一款强效PI3Kα/CK1ε双重抑制剂，于2021年12月启动了首个I期临床试验。其临床结果已在美国血液学年会（ASH）2024上公布。截至2023年5月25日，该研究共纳入38例患者，其中包括26例复发或难治性T细胞淋巴瘤（R/R TCL）和12例复发或难治性B细胞淋巴瘤（R/R BCM）。接受每日1次50/100/200/300/450mg HZ-H08905治疗的患者数分别为1例、9例、14例、13例和1例。结果显示，在可评估疗效的35例患者中，ORR为60%，包括17%（6/35）CR、40%（14/35）部分缓解（PR）和3%（1/35）轻微缓解（MR），DCR为80%；mDOR和中位无进展生存期（mPFS）尚未达到，21例患者仍在接受治疗。此外，HZ-H08905在慢性淋巴细胞白血病（CLL）、弥漫性大B细胞淋巴瘤（DLBCL）、滤泡性淋巴瘤（FL）、套细胞淋巴瘤（MCL）、外周T细胞淋巴瘤（PTCL）和华氏巨球蛋白血症（WM）等多种非霍奇金淋巴瘤（NHL）亚型中表现出优异的抗肿瘤疗效，ORR范围为50%-100%，DCR范围为76%-100%。安全性方面，HZ-H08905在研究中尚未达到剂量限制性毒性（DLT），也未达到最大耐受剂量（MTD）。92%患者出现治疗相关不良事件（TRAE），发生率≥5%的≥3级TRAE为中性粒细胞减少（26.3%）、肺炎（7.9%）、白细胞减少（5.3%）、天冬氨酸转氨酶升高（5.3%）、丙氨酸转氨酶升高（5.3%）和带状疱疹（5.3%）。药物：barzolvolimab 靶点：c-Kit 适应症：慢性自发性荨麻疹 Barzolvolimab（CDX-0159）是Celldex Therapeutics开发的一款同类最佳（best in class）c-Kit单抗，于2019年10月进入临床阶段。下载Celldex AAAAI 2024大会PPT II期研究（NCT05368285）结果显示，慢性自发性荨麻疹（CSU）患者接受barzolvolimab治疗12周后，荨麻疹活动度评分（UAS7）显著下降。下载Celldex AAAAI 2024大会PPT 此外，barzolvolimab对未接受过或接受过奥马珠单抗治疗的患者均有不错的疗效。下载Celldex AAAAI 2024大会PPT 目前，全球共12款临床在研c-Kit靶向药物，其中barzolvolimab、bezuclastinib（Cogent Biosciences）和elenestinib（Blueprint Medicines）是进展最快的三款产品。bezuclastinib和elenestinib均是小分子c-Kit抑制剂，二者的首发适应症有所不同，前者为胃肠道间质瘤，而后者为系统性肥大细胞增生症。药物：BAY 2927088 靶点：EGFR exon 20/HER2 exon 20/EGFR C797S 适应症：非小细胞肺癌 BAY 2927088是拜耳开发的一款口服非共价可逆选择性酪氨酸激酶抑制剂，对携带EGFR和HER2突变（包括HER2 exon 20插入突变）的肿瘤有抑制活性。 I期研究结果显示，69例至少接受过一种系统治疗的非小细胞肺癌（NSCLC）患者接受BAY 2927088治疗后，整体人群ORR为26.0%(18/69)，其中携带HER2 exon 20突变的人群ORR为60.0%（12/20）。今年6月，BAY 2927088片和BAY 2927088溶液被CDE纳入突破性疗法，用于携带HER2（ERBB2）激活突变且既往接受过一种全身性治疗的不可切除或转移性NSCLC。药物：LP-003 靶点：IgE 适应症：季节性过敏性鼻炎 LP-003是天辰生物开发的一款抗IgE单抗，也是进度最快的国产抗IgE单抗。针对过敏性鼻炎的II期研究结果显示，100mg/200mg（每4周1次，共2次）LP-003组患者的花粉季峰值期间（PPP）鼻症状总分（TNSS）显著低于安慰剂组（3.17 vs. 3.45 vs. 4.25分，P<0.05）。此外，LP-003具有良好的安全性，其不良事件发生率与安慰剂组相似。报告的最常见不良事件（两组均>2%）为高尿酸血症、上呼吸道感染和鼻咽炎。目前，全球仅一款抗IgE单抗获批上市，即诺华的奥马珠单抗。在《中国变应性鼻炎诊断和治疗指南（2022年修订版）》中，抗IgE单抗是标准治疗仍不能充分控制的中重度季节性或常年性过敏性鼻炎患者的推荐治疗方案。全球在研抗IgE单抗并不多（仅7款），LP-003和ligelizumab（诺华）是唯二处于III期阶段的产品。全球在研抗IgE单抗（来源：医药魔方Nextpharma数据库） ligelizumab本是诺华计划开发的奥马珠升级版抗IgE单抗，其主推适应症同为荨麻疹和食物过敏。不过，在III期PEARL系列研究中，ligelizumab治疗CSU的效果不如奥马珠单抗。因此，诺华终止了ligelizumab治疗慢性诱导性荨麻疹（CIU）的III期PEARL-PROVOKE研究。令人遗憾的是，今年1月，诺华又终止了ligelizumab治疗花生过敏的III期研究，原因未作详细说明。药物：lutikizumab 靶点：IL-1β/IL-1α 适应症：化脓性汗腺炎 Lutikizumab（ABT-981）是艾伯维开发的一款抗IL-1α/IL-1β双抗，于2012年8月进入临床阶段。lutikizumab的开局并不顺利，先后放弃了在膝骨关节炎和手指关节炎上的探索。今年1月，lutikizumab治疗化脓性汗腺炎的II期研究迎来积极结果。lutikizumab（300mg，每2周1次）组达到HiSCR50（脓肿和炎性结节数量至少减少50%）的患者比例显著高于安慰剂组（59.5% vs. 35%，P=0.027）。化脓性汗腺炎是一种慢性、复发性、进行性、炎症性疾病，患者身上会形成疼痛的囊肿、脓肿和引流瘘管，最终导致不可逆转的皮肤损伤和残疾。全球约1%的人口患有化脓性汗腺炎。这种疾病的诊断不易，患者通常需要7-10年的时间才可确诊。目前，化脓性汗腺炎的治疗选择有限，仅包括司库奇尤单抗（诺华）、比吉利珠单抗（UCB）和阿达木单抗（艾伯维）。药物：belrestotug 靶点：TIGIT 适应症：非小细胞肺癌 Belrestotug是GSK以20.75亿美元自iTeos Therapeutics引进的一款抗TIGIT单抗。在针对NSCLC的II期GALAXIES Lung-201研究中，相比于dostarlimab（抗PD-1单抗）单药组，dostarlimab+belrestotug组患者的肿瘤消退具有临床意义。详细数据尚未公布。基于该积极结果，GSK启动了dostarlimab+belrestotug对比帕博利珠单抗单抗+安慰剂一线治疗NSCLC患者的III期GALAXIES Lung-301研究。除了NSCLC外，GSK也开展了dostarlimab+belrestotug对比dostarlimab一线治疗头颈部鳞状细胞癌（HNSCC）的II期研究。目前，全球共37款TIGIT靶向药物仍处于临床开发状态，其中6款已进入III期阶段，包括belrestotug、domvanalimab（吉利德）、rilvegostomig（阿斯利康）、tiragolumab（罗氏）、vibostolimab（默沙东）和欧司珀利单抗（百济神州）。药物：TAK-861 靶点：OX2R 适应症：发作性睡病猝倒 TAK-861是武田开发的一款OX2R激动剂，于2021年4月进入临床阶段。今年2月，TAK-861治疗1型发作性睡病的II期研究达到主要终点。结果显示，治疗第8周，与安慰剂组相比，TAK-861组患者的客观和主观觉醒指标改善效果均有统计学意义和临床意义。此外，Epworth嗜睡量表（ESS）和每周发作率（WCR）等关键次要终点的改善效果也具有显著的统计学意义和临床意义。发作性睡病（也称为嗜睡症）是一种慢性、罕见的中枢性嗜睡神经系统疾病，可分为1型发作性睡病（NT1）和2型发作性睡病（NT2）。前者是由于食欲素神经元大量缺失导致食欲素缺乏引起的，但后者的食欲素水平一般正常。刺激NT1患者的OX2R可恢复食欲素信号传导。药物：Y-3 靶点：GABRA2/PSD95/nNOS 适应症：缺血性卒中 Y-3是宁丹新药开发的一款nNOS/PSD95解耦联及GABRA2激动剂，可同时干预缺血性卒中后的神经元兴奋性损伤及突触可塑性改变。由于其靶点特异性高，Y-3也可减少NMDA及GABAA受体相关毒性。Y-3具有快速抗抑郁焦虑功能，有望成为首个卒中和卒中后抑郁兼顾同治的新型脑细胞保护剂。 II期研究结果表明，在发病48h内的缺血性脑卒中患者中，相比于安慰剂，Y-3（20/40/60mg，每日1次）能够提高达到90天良好功能预后的患者比例。 2023年8月，康哲药业与宁丹新药达成协议，获得了Y-3在中国大陆、香港特别行政区、澳门特别行政区的独家推广权。脑卒中是严重危害中国国民健康的重大非传染性疾病，中国总体卒中终生发病风险为39.9%，位居全球首位。2019年中国缺血性脑卒中新发人数约287万，1990年到2019年发病率大幅增长226.5%，患者人群规模大。脑卒中具有高致残率和高经济负担等特点，临床急需循证依据充分的药物减轻家庭和社会负担。推荐阅读 2024年5月 | 16款创新药进入III期，11款来自中国药企 2024年4月 | 20款创新药进入III期，11款来自中国药企 2024年3月 | 12款创新药进入III期，5款来自中国药企 2024年2月 | 15款创新药进入III期，5款来自中国药企 2024年1月 | 7款创新药进入III期，4款来自中国药企 2023年12月 | 13款创新药进入III期，6款来自中国药企 2023年11月 | 18款创新药进入III期，8款来自中国药企 2023年10月 | 28款创新药进入III期，9款来自中国药企 Copyright © 2024 PHARMCUBE. All Rights Reserved. 欢迎转发分享及合理引用，引用时请在显要位置标明文章来源；如需转载，请给微信公众号后台留言或发送消息，并注明公众号名称及ID。免责申明：本微信文章中的信息仅供一般参考之用，不可直接作为决策内容，医药魔方不对任何主体因使用本文内容而导致的任何损失承担责任。

临床3期免疫疗法临床2期临床结果临床失败

2024-03-12

·PRNewswire

Longbio Pharma Presented Positive Phase 1 Results for LP-003 at 2024AAD

SAN DIEGO, March 12, 2024 /PRNewswire/ -- Longbio Pharma (Suzhou) Co., Ltd. (referred to as "Longbio Pharma"), a leading biotech company dedicated to developing innovative protein treatments for allergy, respiratory, dermatology, hematology, ophthalmology, and other autoimmune and rare diseases, proudly announced the Phase I data of LP-003 (new generation of anti-IgE antibody) at the 2024 American Academy of Dermatology Association annual meeting (2024AAD). The presentation of the poster titled "A Phase 1 study in healthy subjects of LP-003, a novel long-acting, high affinity anti-IgE antibody" by Longbio Pharma marked a significant moment during the conference. Title: A Phase 1 study in healthy subjects of LP-003, a novel long-acting, high affinity anti-IgE antibody Abstract Submission ID: 50484 Presentation Time: Mar 8-12, 2024 Location: Poster Exhibits Center Results: In a randomized, double-blind, single-ascending-dose Phase I clinical study (CTR20221413), 32 healthy subjects were randomly divided into 5 groups to receive a single intravenous dose of 0.3 mg/kg, 1 mg/kg, 3 mg/kg, 6 mg/kg and 10 mg/kg respectively. Safety, pharmacokinetics, and pharmacodynamics (free IgE levels) profile was evaluated. LP-003 exhibited a non-linear PK characteristic with T1/2 ranging from 44.6 days to 76.5 days, which is approximately 2～3 fold of Omalizumab. Moreover, the free-IgE was suppressed to below detection range for more than 168 days at 1 mg/kg group (except one with high baseline IgE level) to 10 mg/kg group. LP-003 appears to show good safety profile. No Grade 3 and above TEAE was reported, establishing a solid foundation for further investigation and advancement. Chronic spontaneous urticaria (CSU) stands as a prevalent skin disorder affecting approximately 1–2% of the global population. Despite SoC treatment, the efficacy and duration of relief remain significant challenges for patients and healthcare providers alike. Anti-IgE therapy was approved as a second-line treatment, however, only approximately 40% of patients achieving complete response following 300 mg Omalizumab dosing. Thus, a novel anti-IgE treatments offering higher efficacy and prolonged relief is needed. The successful Phase II study of Ligelizumab points a way that anti-IgE antibody with higher IgE affinity and more potent efficacy (FcεRI inhibition) retains the potential to be superior against Omalizumab. In this study, Longbio Pharma developed a new generation of anti-IgE antibody, LP-003, of higher IgE binding affinity, stronger FcεRI inhibition bioactivity, compared to Omalizumab and even Ligelizumab. Meanwhile, LP-003 has a much longer half-life (approximately 45∽76 days) compared to Omalizumab (approximately 17∽20 days). Moreover, a Phase II clinical trial (NCT06228560) of total 200 adult refractory CSU patients, despite up-dosing anti-histamine (H1) treatment, are being enrolled into 5 distinct groups (n=40/group), including three LP-003 treatment groups, one omalizumab treatment group, to provide a head-to-head comparison, and one placebo group. The topline results are expected to be released in early 2025. About LP-003 LP-003, a novel monoclonal anti-IgE antibody was generated, humanized, and engineered by Dr. Sun, Nai-chau, who is the inventor of Omalizumab, and co-founder of Tanox. Based on the 30+ years R&D experience on IgE target, Dr Sun developed a new generation of anti-IgE antibody (LP-003). Its extensive characterization including: affinity, bioactivity (FcεRI and FcεRII/CD23 inhibition), off-target binding and animal study (Tox and efficacy) was conducted. LP-003 just accomplished its Phase II study of allergic rhinitis. The current data shows LP-003 has the potential to become a best-in-class treatment. About Longbio Pharma LongBio Pharma is a biotech company located in Shanghai/Changshu, China. The company, which was founded in 2018, focuses on autoimmune and complement diseases, serving patients and society. For more information, please visit: or please contact: [email protected]. SOURCE Longbio Pharma

临床1期临床2期临床结果AACR会议

100 项与 Ligelizumab 相关的药物交易

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KEGG	Wiki	ATC	Drug Bank
D11761	Ligelizumab	-	DB11856

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适应症	最高研发状态	国家/地区	公司	日期
花生过敏	临床3期	美国	Novartis Pharmaceuticals Corp.	2021-12-07
花生过敏	临床3期	日本	Novartis Pharmaceuticals Corp.	2021-12-07
花生过敏	临床3期	澳大利亚	Novartis Pharmaceuticals Corp.	2021-12-07
花生过敏	临床3期	加拿大	Novartis Pharmaceuticals Corp.	2021-12-07
花生过敏	临床3期	丹麦	Novartis Pharmaceuticals Corp.	2021-12-07
花生过敏	临床3期	法国	Novartis Pharmaceuticals Corp.	2021-12-07
花生过敏	临床3期	德国	Novartis Pharmaceuticals Corp.	2021-12-07
花生过敏	临床3期	意大利	Novartis Pharmaceuticals Corp.	2021-12-07
花生过敏	临床3期	荷兰	Novartis Pharmaceuticals Corp.	2021-12-07
花生过敏	临床3期	西班牙	Novartis Pharmaceuticals Corp.	2021-12-07

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临床结果

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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


NCT03907878 (CTgov)	临床3期	慢性荨麻疹	66	Ligelizumab	襯製衊網網齋築衊醖膚(淵範構網壓鑰餘鏇憲鏇) = 獵夢構蓋製齋蓋齋艱顧齋遞夢淵艱觸鏇襯鏇選 (憲積構膚顧網製願襯鑰, 醖壓網鏇糧憲衊遞顧積 ~ 衊衊獵蓋簾醖觸鹽鑰蓋) 更多	-	2024-03-08
NCT03580369 (CTgov)	临床3期	慢性荨麻疹	1,072	Ligelizumab (Ligelizumab 72 mg)	鹹範網醖鹹遞齋願鏇醖(窪簾壓壓蓋顧鹽選簾衊) = 網網獵衊繭範簾築鏇膚製壓鹹繭艱願餘遞選觸 (鹽糧窪繭膚襯鹹鏇齋糧, 襯獵鏇膚壓獵壓艱範構 ~ 鬱窪壓鏇鏇簾製鑰鏇積) 更多	-	2022-12-30
NCT03580369 (CTgov)	临床3期	慢性荨麻疹	1,072	Ligelizumab (Ligelizumab 120 mg)	鹹範網醖鹹遞齋願鏇醖(窪簾壓壓蓋顧鹽選簾衊) = 觸糧選蓋醖膚範窪憲積製壓鹹繭艱願餘遞選觸 (鹽糧窪繭膚襯鹹鏇齋糧, 憲齋齋餘顧積觸膚衊積 ~ 窪網壓簾壓糧願構淵鹽) 更多	-	2022-12-30
NCT03907878 (Corporate Publications) 人工标引	临床3期	慢性荨麻疹	66	ligelizumab	遞醖鑰壓選範襯夢膚觸(積製選廠窪製憲壓鑰鹽) = 願艱糧製襯觸遞蓋憲淵顧範憲齋餘觸遞壓艱蓋 (願齋顧鑰範遞艱遞襯鑰 ) 更多	积极	2022-10-12
NCT02477332 \| NCT02649218 (Pubmed \| J Allergy Clin Immunol) 人工标引	临床2期	慢性荨麻疹	226	ligelizumab	餘窪顧觸窪壓鬱齋夢醖(齋衊窪積鹹簾醖鬱鹹鏇) = 蓋蓋憲鏇襯築鬱鑰憲網鑰構觸觸餘鹹築鬱選製 (繭願壓餘鹹廠艱繭簾壓 ) 更多	积极	2021-11-13
NCT03437278 (CTgov)	临床2期	慢性荨麻疹	49	Ligelizumab (Ligelizumab 24 mg)	網膚構餘網選淵獵淵遞(艱觸構蓋餘繭繭齋積窪) = 襯襯構憲廠蓋膚衊憲衊獵醖獵網餘襯醖廠廠艱 (衊鹽襯鑰襯觸糧築築襯, 繭選衊顧範選膚夢蓋範 ~ 淵壓鹽顧蓋顧餘蓋築鏇) 更多	-	2021-08-24
NCT03437278 (CTgov)	临床2期	慢性荨麻疹	49	Ligelizumab (Ligelizumab 120 mg)	網膚構餘網選淵獵淵遞(艱觸構蓋餘繭繭齋積窪) = 觸獵構憲鬱顧積獵憲淵獵醖獵網餘襯醖廠廠艱 (衊鹽襯鑰襯觸糧築築襯, 齋鏇積襯醖願選淵鏇繭 ~ 餘繭鏇衊齋淵糧觸鬱網) 更多	-	2021-08-24
NCT02649218 (CTgov)	临床2期	慢性荨麻疹	226	Ligelizumab	襯積壓壓齋製齋膚鏇齋(鑰夢鬱衊窪繭積艱壓窪) = 淵顧壓鹽網醖淵壓構繭憲鹹醖淵獵鹽觸夢艱願 (鏇壓鑰網蓋膚餘範憲構, 製壓網選醖鏇構鬱夢衊 ~ 鏇積繭糧構膚廠鬱獵鏇) 更多	-	2020-08-14
NCT02477332 (CTgov)	临床2期	慢性荨麻疹	382	QGE031 (QGE031 24 mg s.c. q4w)	簾願鹽選餘衊獵製繭蓋(選膚繭鑰鏇襯蓋築網壓) = 選鏇選網蓋遞構繭鬱壓鏇鏇鏇膚繭遞壓鑰鑰夢 (顧壓淵鬱衊淵窪糧獵範, 簾願鏇製艱鹹選願夢積 ~ 衊糧築襯繭範遞膚簾鹹) 更多	-	2018-09-14
NCT02477332 (CTgov)	临床2期	慢性荨麻疹	382	QGE031 (QGE031 72 mg s.c. q4w)	簾願鹽選餘衊獵製繭蓋(選膚繭鑰鏇襯蓋築網壓) = 構膚憲襯網蓋廠構廠鑰鏇鏇鏇膚繭遞壓鑰鑰夢 (顧壓淵鬱衊淵窪糧獵範, 鹽觸簾築顧夢選鬱蓋醖 ~ 窪鏇襯蓋壓膚選膚築壓) 更多	-	2018-09-14
NCT02075008 (CTgov)	临床2期	过敏性哮喘	270	QGE031	艱餘願淵窪壓窪艱齋糧(醖窪壓醖繭積鬱衊願糧) = 觸衊壓鏇醖艱網網觸淵鏇夢蓋簾蓋壓鏇糧襯鑰 (築夢蓋簾遞窪廠齋餘襯, 鑰鹽製網鹽鹹範壓膚醖 ~ 齋顧積淵範鏇鬱艱鹽範) 更多	-	2017-04-25
NCT02336425 (CTgov)	临床2期	哮喘	10	QGE031 (QGE031 240 mg)	窪觸網鹹襯顧糧鹽顧糧(願壓網淵積獵鬱窪糧獵) = 餘鹹蓋鬱膚蓋製積艱顧淵範製製繭膚構衊醖築 (廠鑰獵糧構繭襯糧選蓋, 遞廠蓋衊簾願齋網鹹築 ~ 膚選網窪鏇醖範鹽願簾) 更多	-	2017-04-07
NCT02336425 (CTgov)	临床2期	哮喘	10	QGE031 (QGE031 72 mg)	窪觸網鹹襯顧糧鹽顧糧(願壓網淵積獵鬱窪糧獵) = 遞衊鹹窪鑰範廠觸網糧淵範製製繭膚構衊醖築 (廠鑰獵糧構繭襯糧選蓋, 製餘窪鬱糧遞廠糧願淵 ~ 觸構築鑰醖醖壓繭鹽構) 更多	-	2017-04-07
NCT01716754 (CTgov)	临床2期	哮喘	471	Placebo	簾範衊範鹹醖衊製襯窪(構憲鹹壓餘膚選膚網壓) = 獵範範鏇遞願憲網淵鏇網夢醖遞鏇鹹鑰選膚淵 (鏇醖糧網鬱糧製淵憲範, 顧窪窪獵衊壓鬱鬱衊艱 ~ 遞願選獵醖築艱廠製餘) 更多	-	2017-03-08