A Prospective, Multinational, Multicenter, Randomized, Sequential, Double-blind, Placebo-controlled, Phase 2a Clinical Trial to Assess the Safety and Pharmacokinetics of OMN6 in HABP or VABP Caused by Acinetobacter Baumannii Complex (ABC).

This is a phase 2a, multinational, multicenter, double-blind, randomized, placebo-controlled, dose-ranging safety, tolerability and PK study in patients with HABP (Hospital Acquired Bacterial Pneumonia) or VABP (Ventilator Associated Bacterial Pneumonia) caused by ABC to identify safe and well-tolerated doses and to assess the PK profile of OMN6 in patients.

开始日期2024-10-09

申办/合作机构

Omnix Medical Ltd.初创企业

NL-OMON51720 / CompletedN/A

A First in Human, Phase 1, Randomized, Double-blind, Placebo-controlled, Single Ascending Total Daily Dose Study to Assess Safety, Tolerability, and Pharmacokinetics of Single and Multiple Intravenous Infusion of OMN6 in Healthy Subjects - CS0379-200475 Omnix

开始日期2022-03-28

申办/合作机构

Omnix Medical Ltd.初创企业

100 项与 OMN-6 相关的临床结果

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100 项与 OMN-6 相关的转化医学

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100 项与 OMN-6 相关的专利（医药）

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项与 OMN-6 相关的文献（医药）

Antibiotics

In Vitro and In Vivo Antimicrobial Activity of the Novel Peptide OMN6 against Multidrug-Resistant Acinetobacter baumannii

Article

作者: Hawser, Stephen ; Michaeli, Janna ; Bachnoff, Niv ; Savoia, Paola ; Cohen-Kutner, Moshe ; Duncan, Leonard R. ; Mandel, Shira ; Ferrari, Livia ; Maximov, Shelly ; Zazoun, Jonathan ; Kothari, Nimmi ; Valmont, Thomas

The rapid worldwide spread of antimicrobial resistance highlights the significant need for the development of innovative treatments to fight multidrug-resistant bacteria. This study describes the potent antimicrobial activity of the novel peptide OMN6 against a wide array of drug-resistant Acinetobacter baumannii clinical isolates. OMN6 prevented the growth of all tested isolates, regardless of any pre-existing resistance mechanisms. Moreover, in vitro serial-passaging studies demonstrated that no resistance developed against OMN6. Importantly, OMN6 was highly efficacious in treating animal models of lung and blood infections caused by multidrug-resistant A. baumannii. Taken together, these results point to OMN6 as a novel antimicrobial agent with the potential to treat life-threatening infections caused by multidrug-resistant A. baumannii avoiding resistance.

Scientific Reports3区 · 综合性期刊

OMN6 a novel bioengineered peptide for the treatment of multidrug resistant Gram negative bacteria

3区 · 综合性期刊

ArticleOA

作者: Felici, Antonio ; Mandel, Shira ; Nur, Noa ; Zazoun, Jonathan ; Michaeli, Janna ; Ferrari, Livia ; Erbetti, Isabelle ; Bachnoff, Niv ; Cohen-Kutner, Moshe

AbstractNew antimicrobial agents are urgently needed, especially to eliminate multidrug resistant Gram-negative bacteria that stand for most antibiotic-resistant threats. In the following study, we present superior properties of an engineered antimicrobial peptide, OMN6, a 40-amino acid cyclic peptide based on Cecropin A, that presents high efficacy against Gram-negative bacteria with a bactericidal mechanism of action. The target of OMN6 is assumed to be the bacterial membrane in contrast to small molecule-based agents which bind to a specific enzyme or bacterial site. Moreover, OMN6 mechanism of action is effective on Acinetobacter baumannii laboratory strains and clinical isolates, regardless of the bacteria genotype or resistance-phenotype, thus, is by orders-of-magnitude, less likely for mutation-driven development of resistance, recrudescence, or tolerance. OMN6 displays an increase in stability and a significant decrease in proteolytic degradation with full safety margin on erythrocytes and HEK293T cells. Taken together, these results strongly suggest that OMN6 is an efficient, stable, and non-toxic novel antimicrobial agent with the potential to become a therapy for humans.

项与 OMN-6 相关的新闻（医药）

2024-02-20

·BioSpace

Omnix Medical Granted Fast-Track Designation by U.S. FDA for its Next-Generation Anti-Infective OMN6

Designation underlines the need for novel, first-in-class antimicrobials for the treatment of infections with Gram-negative bacteria JERUSALEM, Israel, February 20, 2023 -- Omnix Medical, a biopharmaceutical company developing next-generation anti-infectives for the treatment of life-threatening infections, today announced that the Company has received fast-track designation for its novel anti-infective OMN6 from the U.S. Food and Drug Administration (FDA). Fast track expedited review is designated to investigational drugs that treat a serious or life-threatening condition and fill an unmet medical need. OMN6 is Omnix Medical´s lead compound and a novel, first-in-class antimicrobial peptide (AMP) based on insect host defense peptides. Its mechanism of action (MoA) fundamentally differs from conventional anti-infectives by physically destroying bacterial cell membranes and allowing a fast and effective onset of action regardless of bacterial genotype or resistance phenotype. In November 2023, Omnix Medical had been granted an IND for a Phase II trial of OMN6 in patients with hospital-acquired bacterial pneumonia (HABP) or ventilator-associated bacterial pneumonia (VABP) caused by Acinetobacter baumannii complex (ABC). Both are life-threatening infections that currently lack fast and effective treatments, most of which fall short due to antimicrobial resistances. "We are excited that the U.S. FDA has granted fast-track designation for our lead compound OMN6," said Dr. Moshik Cohen-Kutner, CEO of Omnix Medical. "This allows us to accelerate the development of game-changing anti-infectives that are designed to be fast-acting and effective without triggering antimicrobial resistances. We are looking forward to obtaining Phase II results." “The fast-track designation brings us one step closer to saving the lives of patients with life-threatening hospital-acquired bacterial pneumonia (HABP) or ventilator-associated bacterial pneumonia (VABP) that do not respond to conventional antibiotics and currently have no further therapeutic options,” added Niv Bachnoff, CSO of Omnix Medical. ### About Omnix Medical Omnix Medical was founded in 2015 to address the urgent unmet need for new life-saving anti-infective drugs. Omnix´ proprietary technology eliminates bacteria by mimicking the innate immune system of insects which uses unique molecules to efficiently and selectively kill resistant bacterial strains without toxic effects. This mechanism, which is at the core of Omnix´ technology, kills bacteria upon contact and has successfully evolved over 200 million years. The Company’s lead compound is being developed for the treatment of life-threatening hospital-acquired infections (HIA) and has shown significantly higher potency than currently available treatments. Most importantly, Omnix´ technology prevents the development of new resistances and is thus well positioned to become the first-line-treatment to win the war against AMR. About OMN6 OMN6 is a novel, first-in-class antimicrobial peptide (AMP) based on insect host defense peptides. Its mechanism of action (MoA) is based on disruption of bacterial cell membranes and is therefore effective regardless of bacterial genotype or resistance phenotype, and unlike conventional bacteriostatic antibiotics, it is fast acting and bactericidal. OMN6 has been optimized from the original AMP by Omnix Medical´s proprietary technology to exhibit not only remarkable efficacy, potency, and safety, but also high stability while maintaining bioactivity. As a result, Omnix Medical believes that its novel peptides can be considered a new class of antimicrobial drugs. OMN6, the Company's lead compound, is intended for the treatment of life-threatening infections caused by Gram-negative bacteria such as Acinetobacter baumannii. Corporate Contacts Moshik Cohen-Kutner, CEO +972-50-8698218 Niv Bachnoff, CSO +972-54-238-6023 contact@omnixmedical.com Media Inquiries akampion Dr. Ludger Wess / Ines-Regina Buth Managing Partners info@akampion.com Tel. +49 40 88 16 59 64 / Tel. +49 30 23 63 27 68 Related Links Twitter LinkedIn

快速通道临床2期合格传染病产品

2023-05-14

·药明康德

乳腺癌中位PFS超四年的联合疗法、防治严重免疫疗法副作用的小分子疗法步入临床... | 一周盘点

▎药明康德内容团队编辑本期看点1. Celcuity公司公布PI3K/mTOR抑制剂gedatolisib的新数据，与CDK4/6抑制剂及内分泌疗法联用后，在HR+/HER2-晚期乳腺癌初治患者中的中位无进展生存期（PFS）进一步延长至48.6个月。2. 新型药用信号细胞（medicinal signaling cell，MSC）疗法Lomecel-B治疗左心发育不全综合征（HLHS）的长期疗效亮眼，患者5岁时的存活率达100%。而历史结果表明，患有HLHS的儿童在5岁时的死亡率约为20%。3. 可用于预防和治疗细胞因子释放综合征（CRS）的小分子疗法步入临床，将于今年夏天启动首个临床试验。药明康德内容团队整理Gedatolisib：公布1b期临床试验的新数据Celcuity公司公布了其潜在“first-in-class”的PI3K/mTOR抑制剂gedatolisib用于HR+/HER2-晚期乳腺癌患者的1b期临床试验的最新结果。该候选药物能够选择性地靶向所有I型PI3K异构体和mTOR，与异构体特异性PI3K抑制剂或mTOR抑制剂相比，同时抑制所有4类I型PI3K异构体和mTOR限制了潜在耐药性的产生。去年12月公布的数据显示，gedatolisib与CDK4/6抑制剂palbociclib以及内分泌疗法fulvestrant或letrozole联用，在晚期初治乳腺癌患者中的表现尤为突出，中位PFS长达42.3个月。此次更新的数据公布截至2023年3月16日，结果显示，这类患者的中位PFS得到了进一步的延长，为48.6个月，中位中位缓解持续时间（DOR）为46.9个月。Lomecel-B：公布1b期临床试验的新数据Longeveron公司公布了其同种异体、来源于健康成人捐赠者骨髓的MSC治疗产品Lomecel-B用于治疗HLHS的新长期生存数据。HLHS是一种罕见且危及生命的先天性心脏缺陷，出生时患有HLHS的婴儿左心室是发育不全或缺失的。该病当前的标准护理包括三个重建心脏手术（1–3期），以重新配置右心室以提供所有心输出量。这三项手术必须在患儿5岁前完成。1期手术（Norwood手术）需在患儿出生后2周内进行，2期手术（Glenn手术）通常在其4-5个月大时进行。3期手术（Fontan手术）一般在孩子4-5岁时进行。如果不进行手术治疗，病情将会是致命的。而即使进行了重建手术，患儿也通常会在15岁时死亡或需要心脏移植。Lomecel-B具有多种作用机制，包括促血管、促再生、抗炎以及组织修复和愈合作用，在一系列疾病领域具有广泛的潜在应用。此次公布的数据显示，在2期手术期间接受Lomecel-B治疗后，100%（10名）的患者存活到了5岁。而历史结果表明，患有HLHS的儿童在5岁时的死亡率约为20%。截至目前，参与该研究的所有患者在使用Lomecel-B治疗后至少接受了3.5年的监测。此外，在第2阶段手术后大约三年，5名符合条件的患者均已完成了第3次手术。CTO1681：IND申请获得FDA许可CTO1681是CytoAgents公司开发的用于预防和治疗肿瘤CRS的小分子药物，可激活免疫细胞的天然信号通路，以下调多种细胞因子的产生。CTO1681可显著减少（但不会消除）免疫细胞产生的细胞因子，重新平衡免疫反应，同时保持其必要功能完好无损。该公司计划于今年夏天启动该疗法的首个临床试验。RP-A601：IND申请获得FDA许可RP-A601是Rocket Pharmaceuticals公司开发的一种基因疗法，由AAV.rh74包裹的人类PKP2转基因组成，以单次静脉注射的形式给药。该疗法旨在治疗PKP2致病突变引起的致心律失常性心肌病，这是一种破坏性的遗传性心脏病，可导致危及生命的心律失常、心脏结构异常和心源性猝死。现有的治疗方法无法解决导致该病的根本原因，即使经过治疗，仍可能发生危及生命的心律失常和疾病进展。INO-3107：公布1/2期临床试验的新数据INOVIO公司公布了其候选DNA疗法INO-3107的1/2期临床试验的新数据。INO-3107正在被开发用于治疗成人HPV 6和HPV 11相关的复发性呼吸道乳头状瘤病（RRP），旨在引发针对HPV 6和HPV 11的靶向T细胞反应，以杀死受感染的细胞，使乳头状瘤消退。该疗法还可能清除或降低病毒水平，从而防止或减缓新乳头状瘤的生长。此次公布的数据显示，与前一年相比，使用INO-3107治疗的32名受试者中，有26名（81.3%）手术干预次数降低，其中9名受试者在试验期间无需手术干预。此外，INO-3107具有良好的耐受性和免疫原性。2020年，FDA授予INO-3107孤儿药资格，用于治疗RRP。INKmune：IND申请获得FDA许可INKmune是INmune Bio公司开发的新型的自然杀伤细胞（NK）免疫疗法，用于治疗转移性去势抵抗性前列腺癌（mCRPC）。INKmune是一种可提高患者自身NK细胞功能的产品，它是一种临床级别的、无复制能力的人类肿瘤细胞株，能够与静息NK细胞结合并提供多个基本的启动信号，类似于至少3种细胞因子的联合治疗。INKmune在-80℃时保持稳定，能通过简单的静脉输液途径进行输注，并且不需要任何形式的调理、预处理或细胞因子支持。该公司预计于2023年下半年开始招募患者，并在4个临床研究站点开展，旨在确定INKmune的短期和长期安全性、证明INKmune控制前列腺癌肿瘤负荷的能力，并确定INKmune的剂量。LASN01：公布1期临床试验数据Lassen Therapeutics公司公布了其用于治疗肺纤维化的IL-11受体阻断抗体LASN01的1期临床试验数据。IL-11是纤维化发生的中心介质，阻断其活性有可能为治疗甲状腺眼病和其他纤维化疾病提供新的方式。此前的研究结果显示，LASN01阻断IL-11通路可抑制人和小鼠成纤维细胞中的STAT3和ERK活化，并且在体外、体内和人类离体样本中具有抗纤维化作用。此次公布的数据显示，LASN01具有剂量线性的药代动力学特征，在健康志愿者中安全性良好。在基于血液的测定中，LASN01可以剂量依赖性地抑制受体信号，证明了其有效活性。OMN6：公布1期临床试验数据Omnix Medical公司公布了其新型抗菌肽OMN6的1期临床试验数据。OMN6是一种全新的抗感染药，其作用机制完全不同于传统的抗生素。该药物通过破坏细菌细胞膜的方式发挥作用，因此不受细菌基因型或耐药表型的影响，具有快速杀菌作用。OMN6旨在治疗由革兰氏阴性细菌（例如鲍曼不动杆菌）引起的危及生命的感染。该临床试验结果表明，OMN6在所有剂量水平上均没有出现严重不良事件，同时血液中的OMN6水平具有临床意义。此外，该研究还证明了OMN6在血液中能够被完全清除，允许每天进行多次输注。EXT608：公布1期临床试验数据Extend Biosciences公司公布了其甲状旁腺激素（PTH）的长效衍生物EXT608的首次人体实验的积极结果。EXT608旨在通过显著降低给药频率和提高生物利用度来替代PTH的生理效应。中期数据分析表明，EXT608的安全性和耐受性良好，未报告严重不良事件。用药后，血清钙呈剂量依赖性增加，而尿钙没有伴随增加。研究人员还观察到内源性PTH的长期抑制。一项早期药代动力学分析表明，每周给药一次EXT608是可行的。PMN310：IND申请获得FDA许可PMN310是ProMIS Neurosciences公司开发的用于治疗阿尔茨海默病的新型单克隆抗体，能够高选择性地靶向被认为是阿尔茨海默病的主要驱动因素的β淀粉样蛋白（Aβ）寡聚体。在临床前研究中，PMN310与其他靶向Aβ的抗体相比，对Aβ寡聚体表现出更强大的体外靶向作用。此外，PMN310未观察到与斑块的结合，可能会降低使用斑块结合抗体引起的淀粉样蛋白相关成像异常（ARIA）的风险。这些数据支持该疗法具有潜在的差异化临床特征。OP-1250：公布1b/2期临床试验的新数据Olema Oncology公布了其候选药物OP-1250联用CDK4/6抑制剂palbociclib治疗晚期和/或转移性ER+/HER2-乳腺癌患者的1b/2期临床试验的新数据。OP-1250是一种具有完全ER拮抗剂（CERAN）和选择性ER降解剂（SERD）这两种双重活性的口服小分子药物。此次公布的数据显示，该联合疗法的耐受性良好，没有剂量限制性毒性，也没有观察到药物相互作用，总体耐受性特征与FDA批准的palbociclib联用内分泌药物的标签一致。此外，在先前接受过CDK4/6抑制剂治疗的患者中观察到联合疗法的抗肿瘤作用。截至目前，临床获益率为42%（5/12），获益的5名患者均达到了部分缓解。59%的患者仍在接受治疗，并且该试验正在进行额外的患者招募。PRAX-628：公布1期临床试验数据Praxis Precision Medicines公司公布了其下一代功能选择性小分子PRAX-628在健康受试者中的积极数据。PRAX-628旨在靶向大脑中钠通道的过度兴奋状态，目前正在开发为成人局灶性癫痫的每日一次口服治疗药物。此次公布的数据显示，在超过小鼠最大电休克发作模型（MES，一种能够高度预测局灶性癫痫疗效的转化模型）半数效应浓度（EC50）15倍的浓度下，PRAX-628依然表现出良好的安全性和耐受性。根据MES模型，PRAX-628预测的治疗范围至少比当前获批药物宽3倍。该结果支持PRAX-628的临床前特性，表明其具有潜在“best-in-class”疗效的潜力。SER-155：公布1b期临床试验数据Seres Therapeutics公司公布了其在研口服微生物组疗法SER-155的初步临床数据。SER-155旨在预防肠源性感染和由此产生的血流感染，并诱导免疫耐受反应以降低接受异基因造血干细胞移植（allo-HSCT）的患者发生移植物抗宿主病（GvHD）的发生率。临床前研究显示，SER-155能够显著抑制耐碳青霉烯类肠杆菌科（CRE）和耐万古霉素肠球菌（VRE）的菌群的定植，并进一步调节肠上皮屏障完整性和与GvHD相关的T细胞生物学。此次公布的结果显示，SER-155的耐受性良好，没有相关的严重不良事件。大家都在看药明康德为全球生物医药行业提供一体化、端到端的新药研发和生产服务，服务范围涵盖化学药研发和生产、生物学研究、临床前测试和临床试验研发、细胞及基因疗法研发、测试和生产等领域。如您有相关业务需求，欢迎点击下方图片填写具体信息。▲如您有任何业务需求，请长按扫描上方二维码，或点击文末“阅读原文/Read more”，即可访问业务对接平台，填写业务需求信息▲欲了解更多前沿技术在生物医药产业中的应用，请长按扫描上方二维码，即可访问“药明直播间”，观看相关话题的直播讨论与精彩回放参考资料（可上下滑动查看）[1] ProMIS Neurosciences Announces FDA Clearance of Investigational New Drug (IND) Application for PMN310 in Alzheimer’s Disease. Retrieved May 12, 2023, from https://www.globenewswire.com/news-release/2023/05/08/2663370/0/en/ProMIS-Neurosciences-Announces-FDA-Clearance-of-Investigational-New-Drug-IND-Application-for-PMN310-in-Alzheimer-s-Disease.html[2] Omnix Medical Announces Excellent Topline Data from the Phase I Clinical Trial of its Novel Anti-Infective OMN6. Retrieved May 12, 2023, from https://www.globenewswire.com/news-release/2023/05/08/2663003/0/en/Omnix-Medical-Announces-Excellent-Topline-Data-from-the-Phase-I-Clinical-Trial-of-its-Novel-Anti-Infective-OMN6.html[3] INmune Bio, Inc. Announces FDA Clearance of IND Application for INKmune™, a Natural Killer Therapy, for a Phase I/II Trial in Metastatic Castration-Resistant Prostate Cancer. Retrieved May 12, 2023, from https://www.globenewswire.com/news-release/2023/05/08/2663246/0/en/INmune-Bio-Inc-Announces-FDA-Clearance-of-IND-Application-for-INKmune-a-Natural-Killer-Therapy-for-a-Phase-I-II-Trial-in-Metastatic-Castration-Resistant-Prostate-Cancer.html[4] New Data from Phase 1/2 Trial of INO-3107 for the Treatment of Recurrent Respiratory Papillomatosis Presented at ABEA during COSM 2023. Retrieved May 12, 2023, from https://www.prnewswire.com/news-releases/new-data-from-phase-12-trial-of-ino-3107-for-the-treatment-of-recurrent-respiratory-papillomatosis-presented-at-abea-during-cosm-2023-301817851.html[5] Seres Therapeutics Reports SER-155 Phase 1b Cohort 1 Results Showing Successful Drug Bacteria Engraftment and Substantial Reduction in Pathogen Domination in the Gastrointestinal Microbiome. Retrieved May 12, 2023, from https://www.businesswire.com/news/home/20230509005470/en[6] HOOKIPA Announces First Person Dosed in Phase 1a/b Clinical Trial of HB-400, in Collaboration with Gilead, for Treatment of Hepatitis B. Retrieved May 12, 2023, from https://www.globenewswire.com/news-release/2023/05/09/2664262/0/en/HOOKIPA-Announces-First-Person-Dosed-in-Phase-1a-b-Clinical-Trial-of-HB-400-in-Collaboration-with-Gilead-for-Treatment-of-Hepatitis-B.html[7] Rocket Pharmaceuticals Announces FDA Clearance of IND for Clinical Trial of RP-A601 for PKP2 Arrhythmogenic Cardiomyopathy (ACM). Retrieved May 12, 2023, from https://www.businesswire.com/news/home/20230509005540/en[8] Boundless Bio Announces First Patient Dosed in First-in-Human Phase 1/2 Clinical Trial of BBI-355 in Patients with Solid Tumors Harboring Oncogene Amplification. Retrieved May 12, 2023, from https://www.businesswire.com/news/home/20230509005428/en[9] FDA Removes Partial Clinical Hold on Salarius Pharmaceuticals’ Phase 1/2 Clinical Trial with Seclidemstat in Patients with Ewing Sarcoma. Retrieved May 12, 2023, from https://investors.salariuspharma.com/news-releases/news-release-details/fda-removes-partial-clinical-hold-salarius-pharmaceuticals-phase[10] Onconova Therapeutics Doses First Patient In Phase 1/2a Trial Of Narazaciclib Combined With Letrozole In Endometrial Cancer. Retrieved May 12, 2023, from https://investor.onconova.com/news-releases/news-release-details/onconova-therapeutics-doses-first-patient-phase-12a-trial[11] Delix Therapeutics Initiates Phase I Trial of a Novel Compound DLX-001. Retrieved May 12, 2023, from https://www.prnewswire.com/news-releases/delix-therapeutics-initiates-phase-i-trial-for-novel-compound-dlx-001-301817260.html[12] Cytokinetics Announces Initiation of Phase 1 Clinical Study of CK-4021586. Retrieved May 12, 2023, from https://ir.cytokinetics.com/news-releases/news-release-details/cytokinetics-announces-initiation-phase-1-clinical-study-ck-1[13] Codagenix Initiates Dosing in Phase 1 Study of Intranasal, Live-Attenuated RSV Vaccine, CodaVax™- RSV, in a Pediatric Population. Retrieved May 12, 2023, from https://www.prnewswire.com/news-releases/codagenix-initiates-dosing-in-phase-1-study-of-intranasal-live-attenuated-rsv-vaccine-codavax--rsv-in-a-pediatric-population-301819768.html[14] FSD Pharma Completes Dosing of First Cohort in Phase I Clinical Trial of Lucid-MS, a New Drug Candidate for the Treatment of Multiple Sclerosis: Safety Review Committee Recommends Commencing Dosing of Second Cohort. Retrieved May 12, 2023, from https://www.businesswire.com/news/home/20230510005267/en[15] Transgene - First Patient Dosed in Phase I Trial Evaluating TG6050, a Novel IL-12-Armed Oncolytic Virus Administered Intravenously, in Non-Small Cell Lung Cancer. Retrieved May 12, 2023, from https://www.businesswire.com/news/home/20230509005933/en[16] Celcuity Presents Updated Results from Phase 1b Study of Gedatolisib in Treatment-Naïve Patients at the 2023 ESMO Breast Cancer Annual Congress. Retrieved May 12, 2023, from https://www.accesswire.com/754389/Celcuity-Presents-Updated-Results-from-Phase-1b-Study-of-Gedatolisib-in-Treatment-Nave-Patients-at-the-2023-ESMO-Breast-Cancer-Annual-Congress[17] Lassen Therapeutics Announces Oral Presentation of Phase I Data of LASN01, an IL-11 Receptor-Blocking Antibody for Treatment of Pulmonary Fibrosis, at the American Thoracic Society 2023 Annual Meeting. Retrieved May 12, 2023, from https://www.businesswire.com/news/home/20230509005136/en[18] Longeveron Announces New Long-Term Survival Data from ELPIS I Trial of Lomecel-B™ for Hypoplastic Left Heart Syndrome. Retrieved May 12, 2023, from https://investors.longeveron.com/news/News/news-details/2023/Longeveron-Announces-New-Long-Term-Survival-Data-from-ELPIS-I-Trial-of-Lomecel-Bfor-Hypoplastic-Left-Heart-Syndrome/default.aspx[19] Olema Oncology Announces OP-1250 Continues to Demonstrate Attractive Combinability with CDK4/6 Inhibitor Palbociclib in Phase 1b/2 Study. Retrieved May 12, 2023, from https://ir.olema.com/news-releases/news-release-details/olema-oncology-announces-op-1250-continues-demonstrate[20] Extend Biosciences Announces Positive Data from Phase 1 Trial of EXT608 for the Treatment of Hypoparathyroidism. Retrieved May 12, 2023, from https://www.businesswire.com/news/home/20230511005123/en[21] PRAXIS PRECISION MEDICINES ANNOUNCES POSITIVE TOPLINE RESULTS FROM PRAX-628 PHASE 1 STUDY ENABLING BEST-IN-CLASS PROFILE. Retrieved May 12, 2023, from https://investors.praxismedicines.com/news-releases/news-release-details/praxis-precision-medicines-announces-positive-topline-results[22] CytoAgents Announces FDA Acceptance of IND Application for CTO1681 to Treat Cytokine Release Syndrome in Oncology. Retrieved May 12, 2023, from https://www.businesswire.com/news/home/20230511005053/en免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。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：本文来自药明康德内容团队，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

免疫疗法临床结果临床2期临床3期

100 项与 OMN-6 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
医院获得性细菌性肺炎	临床2期	以色列	Omnix Medical Ltd.初创企业	2024-10-09
呼吸机相关细菌性肺炎	临床2期	以色列	Omnix Medical Ltd.初创企业	2024-10-09
革兰氏阴性菌感染	临床1期	美国	Omnix Medical Ltd.初创企业	2018-12-29

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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


NCT06087536 (Corporate Publications) 人工标引	临床2期	革兰氏阴性菌感染	-	OMN6	(醖憲鏇餘鏇積憲廠夢艱) = Upon single infusions, the half-life increases from 0.08h at 7.5 mg to about 0.9h at 80 and 100 mg. 獵選觸壓蓋觸獵襯範遞 (願壓積襯膚積襯壓糧獵 ) 更多	积极	2024-05-10