▎药明康德本期看点1. 单抗疗法briquilimab在针对慢性自发性荨麻疹患者开展的1b/2a期研究中表现亮眼，两个单剂量队列中有89%的患者达成完全缓解（CR）。2. 噬菌体疗法BX004用于治疗囊性纤维化（CF）患者因铜绿假单胞菌引起的慢性肺部感染，在一项早期临床试验中与安慰剂相比显著降低了细菌数量约500倍，无耐药发生，同时有效保护了健康微生物组。Briquilimab：公布1b/2a期临床试验数据Jasper Therapeutics公司公布了其候选单抗briquilimab用于治疗慢性自发性荨麻疹的1b/2a期研究BEACON的初步数据。Briquilimab是一种非糖基化单克隆抗体，可通过靶向细胞表面受体c-Kit（也称为CD117）以避免与干细胞因子结合，从而阻断肥大细胞中的关键生存信号，造成细胞凋亡与耗竭，从而消除肥大细胞驱动疾病（如慢性荨麻疹）中炎症反应的潜在来源。此次公布的结果显示，briquilimab在240 mg和360 mg单剂量队列中表现出深度且快速的疾病控制效果，两组共9名受试者中有8人（89%）实现了CR，7人（78%）在第2周即达到临床缓解。此外，在BEACON研究中完成治疗并转入开放标签扩展研究、接受每8周180 mg剂量治疗的受试者中，也显示出强大的临床疗效：在第12周时，11名受试者中有8人（73%）达到了CR。安全性方面，研究期间未报告任何≥3级的治疗相关不良事件。BX004：公布1b/2a期临床试验数据BiomX公司宣布，其噬菌体疗法BX004的首个人体试验结果已在学术期刊Nature Communications上发表。BX004是一种固定的多噬菌体组合疗法，用于治疗囊性纤维化患者因铜绿假单胞菌引起的慢性肺部感染。铜绿假单胞菌是导致CF患者发病和死亡的主要原因之一。论文中的数据表明，在针对抗生素耐药性铜绿假单胞菌感染的1b/2a期临床试验中，BX004的安全性和耐受性良好，在所有患者中和所有测试剂量水平下均未发生治疗相关安全事件。与接受安慰剂治疗的患者相比，接受BX004治疗患者的细菌数量下降了2.7 log₁₀（约500倍），且未出现耐药现象，同时有效保护了患者的健康微生物组。该公司正在推进BX004的2b期临床试验，预计将于2026年第一季度获得顶线结果。Paxalisib：公布1b期联合治疗试验中首例患者的数据Kazia Therapeutics公司公布了一项1b期临床试验中首例患者的初步结果，该研究旨在评估其可穿越血脑屏障的在研口服PI3K/Akt/mTOR通路抑制剂paxalisib联用帕博利珠单抗和标准化疗的疗效与安全性。该公司于2016年底从基因泰克（Genentech）获得了paxalisib的许可。该疗法此前已获得多项资格，包括美国FDA授予的针对胶质母细胞瘤的孤儿药资格和快速通道资格（FTD），针对携带PI3K通路突变、需联合放疗治疗的实体瘤脑转移适应症的FTD，以及针对弥漫性内生性桥脑胶质瘤（DIPG）和非典型畸胎样/横纹肌样肿瘤的孤儿药资格与罕见儿科疾病认定。此次公布的结果显示，一名61岁、肿瘤已局部转移至左肺上叶的三阴性乳腺癌女性患者在接受治疗仅21天后，其循环肿瘤细胞（CTCs）减少了超过50%，且CTC细胞簇也显著减少。这些早期临床数据与此前公布的临床前数据一致。ELU42：IND申请获得FDA许可Eluciderm公司宣布，美国FDA已批准其针对新药ELU42的IND申请，可开展一项针对糖尿病足溃疡（DFUs）患者的1/2a期开放标签研究，以评估ELU42的安全性和疗效。ELU42是一款新型外用小分子Wnt通路调节剂，具有抑菌特性，旨在治疗慢性开放性伤口。参考资料（可上下滑动查看）[1] Eleva administers first dose of its Factor H biological treatment in C3-Glomerulopathy to healthy volunteers. Retrieved July 11, 2025, from https://elevabiologics.com/eleva-administers-first-dose-of-its-factor-h-biological-treatment-in-c3-glomerulopathy-to-healthy-volunteers/[2] First patient dosed in the Phase I clinical trial of PulseSight Therapeutics’ PST-611 treatment for dry AMD/Geographic Atrophy. Retrieved July 11, 2025, from https://pulsesight.com/2025/07/07/first-patient-dosed-in-the-phase-i-clinical-trial-of-pulsesight-therapeutics-pst-611-treatment-for-dry-amd-geographic-atrophy/[3] Eluciderm, Inc. Announces U.S. FDA Clearance of IND Application for ELU42. Retrieved July 11, 2025, from https://www.businesswire.com/news/home/20250708620364/en/Eluciderm-Inc.-Announces-U.S.-FDA-Clearance-of-IND-Application-for-ELU42[4] Solid Biosciences Announces FDA IND and Health Canada CTA Approval for First-in-Class Cardiac Gene Therapy to Treat Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT). Retrieved July 11, 2025, from https://www.globenewswire.com/news-release/2025/07/08/3112195/0/en/Solid-Biosciences-Announces-FDA-IND-and-Health-Canada-CTA-Approval-for-First-in-Class-Cardiac-Gene-Therapy-to-Treat-Catecholaminergic-Polymorphic-Ventricular-Tachycardia-CPVT.html[5] Sensorium Therapeutics Receives FDA IND Clearance for SNTX-2643, a First-in-Class, Rapid-Acting Anxiolytic. Retrieved July 11, 2025, from https://www.prnewswire.com/news-releases/sensorium-therapeutics-receives-fda-ind-clearance-for-sntx2643-a-firstinclass-rapidacting-anxiolytic-302499309.html[6] BiomX Announces Publication in Nature Communications of Phage Cocktail BX004 Phase 1b/2a Part 1 Data Demonstrating Strong Activity in Cystic Fibrosis. Retrieved July 11, 2025, from https://www.globenewswire.com/news-release/2025/07/08/3111723/0/en/BiomX-Announces-Publication-in-Nature-Communications-of-Phage-Cocktail-BX004-Phase-1b-2a-Part-1-Data-Demonstrating-Strong-Activity-in-Cystic-Fibrosis.html[7] Purespring Therapeutics announce FDA IND clearance for Phase I/II clinical trial for primary IgA nephropathy (IgAN). Retrieved July 11, 2025, from https://www.globenewswire.com/news-release/2025/07/09/3112303/0/en/Purespring-Therapeutics-announce-FDA-IND-clearance-for-Phase-I-II-clinical-trial-for-primary-IgA-nephropathy-IgAN.html[8] Avenzo Therapeutics Announces First Patient Dosed in Phase 1/2 Clinical Study of AVZO-1418, a Potential Best-in-Class EGFR/HER3 Bispecific Antibody-Drug Conjugate. Retrieved July 11, 2025, from https://avenzotx.com/press-releases/avenzo-therapeutics-announces-first-patient-dosed-in-phase-1-2-clinical-study-of-avzo-1418-a-potential-best-in-class-egfr-her3-bispecific-antibody-drug-conjugate/[9] BlueRock Therapeutics announces first patient receives investigational therapy in Phase 1/2a clinical trial of OpCT-001 for the treatment of primary photoreceptor diseases. Retrieved July 11, 2025, from https://www.bayer.com/en/us/news-stories/treatment-of-primary-photoreceptor-diseases-0[10] Jasper Therapeutics Reports Clinical Data Update from Briquilimab Studies in Chronic Spontaneous Urticaria. Retrieved July 11, 2025, from https://ir.jaspertherapeutics.com/news-releases/news-release-details/jasper-therapeutics-reports-clinical-data-update-briquilimab#:~:text=REDWOOD%20CITY%2C%20Calif.%2C%20July%2007%2C%202025%20%28GLOBE%20NEWSWIRE%29,CSU%20and%20providing%20an%20update%20on%20the%20program.[11] Kazia Therapeutics Reports Early Efficacy Data from First Triple-Negative Breast Cancer Patient Receiving Paxalisib Combination Regimen achieving >50% Reduction in Circulating Tumor Cells in Phase 1b Trial. Retrieved July 11, 2025, from https://www.prnewswire.com/news-releases/kazia-therapeutics-reports-early-efficacy-data-from-first-triple-negative-breast-cancer-patient-receiving-paxalisib-combination-regimen-achieving-50-reduction-in-circulating-tumor-cells-in-phase-1b-trial-302500778.html[12] The Institute for Research in Immunology and Cancer (IRIC) of the Université de Montréal and IRICoR Announce initiation of Phase 1 Trial of Licensed Small Molecule Therapy for Solid Tumors. Retrieved July 11, 2025, from https://www.prnewswire.com/news-releases/the-institute-for-research-in-immunology-and-cancer-iric-of-the-universite-de-montreal-and-iricor-announce-initiation-of-phase-1-trial-of-licensed-small-molecule-therapy-for-solid-tumors-302499345.html[13] Neumora Therapeutics Announces Initiation of Phase 1 Clinical Study of M4 Positive Allosteric Modulator NMRA-861. Retrieved July 11, 2025, from https://ir.neumoratx.com/news-releases/news-release-details/neumora-therapeutics-announces-initiation-phase-1-clinical-study[14] Cocrystal Pharma to Present Data from Phase 1 Study of First-in-Class Norovirus Protease Inhibitor CDI-988 at the 9th International Calicivirus Conference. Retrieved July 11, 2025, from https://www.globenewswire.com/news-release/2025/07/10/3113201/0/en/Cocrystal-Pharma-to-Present-Data-from-Phase-1-Study-of-First-in-Class-Norovirus-Protease-Inhibitor-CDI-988-at-the-9th-International-Calicivirus-Conference.html[15] Krystal Biotech Announces First Patient Dosed in Phase 1/2 Trial of KB801 for the Treatment of Neurotrophic Keratitis. Retrieved July 11, 2025, from https://www.globenewswire.com/news-release/2025/07/09/3112425/0/en/Krystal-Biotech-Announces-First-Patient-Dosed-in-Phase-1-2-Trial-of-KB801-for-the-Treatment-of-Neurotrophic-Keratitis.html免责声明：本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。版权说明：欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「药明康德」微信公众号回复“转载”，获取转载须知。分享，点赞，在看，聚焦全球生物医药健康创新

临床结果微生物疗法临床2期临床1期

2025-07-09

·PipelineReview

Eluciderm, Inc. Announces U.S. FDA Clearance of IND Application for ELU42

SAN DIEGO, CA, USA I July 08, 2025 I Eluciderm, Inc., a clinical-stage pharmaceutical company developing small molecule therapeutics designed to promote healing and regenerative repair of injured tissue, announced today that on June 30, 2025 the company received clearance from the U.S. Food & Drug Administration (FDA) for its Investigational New Drug (IND), ELU42, for a Phase 1/2a open-label study evaluating safety and efficacy in patients with diabetic foot ulcers (DFUs). ELU42 is a novel, topical, small molecule Wnt modulator with bacteriostatic properties for the treatment of chronic open wounds. “The FDA’s IND clearance of ELU42 marks an exciting transition for Eluciderm from preclinical research to full clinical-stage company,” said Daniel D. Holsworth, PhD, Chief Executive Officer of Eluciderm. “ELU42 is the first in our pipeline of Wnt signaling modulators developed around a novel mechanistic approach to tissue healing and repair that we believe will shift the paradigm from simply managing patients’ wounds to truly healing them.” The ELU42 Phase 1/2a trial is an open-label study evaluating the topical spray for safety and efficacy in a cohort of 15 patients with diabetic foot ulcers (DFUs). The study is set to begin the first week of August 2025 at three U.S. sites and will assess multiple clinical endpoints, including wound area reduction, closure rates, and safety metrics. The data from this trial will establish the foundation of a Phase 2 clinical trial in 2026, with strong potential for a Breakthrough Therapy designation in early 2027. “This first-in-human trial is a defining moment for Eluciderm. ELU42 has the potential to change the standard of care for patients worldwide who suffer from non-healing wounds and underscores our commitment to transforming wound care,” said John P. Delgado, MD, Chief Medical Officer of Eluciderm. “We believe everyone can be a SuperHealer TM .” About Eluciderm, Inc. Eluciderm is a San Diego-based clinical-stage pharmaceutical company pioneering topical small-molecule therapies that awaken the body’s innate healing capacity. The company’s approach is grounded in a targeted mechanism of action that selectively modulates the Wnt signaling pathway, with the goal of redefining wound healing and clinical outcomes. Eluciderm’s platform, anchored by ELU42, includes therapeutics designed to promote healing and regenerative repair of a wide variety of wound injuries, including those from third-degree burns, surgical incisions, elastic cartilage reconstructions, pulmonary fibrotic damage from environmental factors, and inflammatory skin diseases. Based on favorable data from the National Cancer Institute’s NCI-60 screening program, Eluciderm is also in the early stages of investigating oncological applications of their mechanistic methodology. For more information, visit www.eluciderm.com and follow Eluciderm on LinkedIn . SOURCE: Eluciderm

临床申请临床2期

100 项与 ELU-42 相关的药物交易

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