- Phase I data show safety and tolerability at clinically significant dose levels- New class of anti-infectives to treat infections with Gram-negative bacteria JERUSALEM, Israel, November 20, 2023 -- Omnix Medical, a biopharmaceutical company developing next-generation anti-infectives for the treatment of life-threatening infections, today announced that the U.S.

-第一阶段数据显示临床显著剂量水平的安全性和耐受性-治疗革兰氏阴性菌感染的新型抗感染药物耶路撒冷，以色列，2023年11月20日-Omnix Medical，一家开发下一代抗感染药物的生物制药公司今天宣布美国。

Food and Drug Administration (FDA) has approved a planned Phase II trial of the Company´s novel anti-infective OMN6. The multinational, multicenter trial will assess the safety and pharmacokinetics of OMN6 in patients with hospital-acquired bacterial pneumonia (HABP) or ventilator-associated bacterial pneumonia (VABP) caused by Acinetobacter baumannii complex (ABC).

美国食品和药物管理局（FDA）已批准该公司新型抗感染OMN6的计划II期试验。多国多中心试验将评估OMN6在由鲍曼不动杆菌复合体（ABC）引起的医院获得性细菌性肺炎（HABP）或呼吸机相关性细菌性肺炎（VABP）患者中的安全性和药代动力学。

Omnix Medical´s lead compound OMN6 is a novel, first-in-class antimicrobial peptide (AMP) based on insect host defense peptides. Its mechanism of action (MoA) is based on a totally novel principle compared to conventional anti-infectives:the compound destroys bacterial cell membranes, enabling a fast and effective onset of action regardless of bacterial genotype or resistance phenotype.

Omnix Medical的先导化合物OMN6是一种基于昆虫宿主防御肽的新型一流抗菌肽（AMP）。与常规抗感染药相比，其作用机制（MoA）基于全新的原理：该化合物破坏细菌细胞膜，无论细菌基因型或抗性表型如何，都能快速有效地起作用。

In a randomized, double-blind, placebo-controlled, single ascending dose Phase I study with over 80 healthy volunteers, OMN6 has demonstrated excellent safety and tolerability at clinically significant dose levels. Moreover, complete clearance of the drug could be shown, allowing for multiple daily infusions as is common with anti-infective treatments.

在一项随机，双盲，安慰剂对照，单次递增剂量I期研究中，超过80名健康志愿者，OMN6在临床显着剂量水平上表现出优异的安全性和耐受性。此外，可以显示药物的完全清除，允许多次每日输注，这与抗感染治疗一样。

'We are very pleased that the U.S. FDA has approved our planned Phase II study,' said Dr. Moshik Cohen-Kutner, CEO of Omnix Medical. 'As we have seen very encouraging results in our previous Phase I trial, we hope that the Phase II data will confirm these data. This would be a key milestone in the development of a no.

“我们非常高兴美国FDA批准了我们计划的II期研究，”Omnix Medical首席执行官Moshik Cohen Kutner博士说正如我们在之前的第一阶段试验中看到的非常令人鼓舞的结果，我们希望第二阶段的数据能够证实这些数据。这将是制定否的关键里程碑。