- 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.

-2023年2月20日，以色列耶路撒冷——Omnix Medical是一家开发下一代抗感染药物以治疗危及生命的感染的生物制药公司，今天宣布，该公司已从美国获得其新型抗感染OMN6的快速通道指定。

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.

美国食品和药物管理局（FDA）。快速通道快速审查被指定用于治疗严重或危及生命的疾病并满足未满足的医疗需求的研究药物。OMN6是Omnix Medical的先导化合物，是一种基于昆虫宿主防御肽的新型一流抗菌肽（AMP）。

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).

它的作用机制（MoA）与传统的抗感染药物有根本的不同，它通过物理破坏细菌细胞膜并允许快速有效的作用开始，而不管细菌基因型或耐药表型如何。2023年11月，Omnix Medical获得了IND，用于OMN6的II期临床试验，用于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。

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.

两者都是危及生命的感染，目前缺乏快速有效的治疗方法，其中大多数由于抗菌素耐药性而达不到要求。”Omnix Medical首席执行官莫希克·科恩·库特纳（MoshikCohenKutner）博士说，我们很高兴美国食品和药物管理局（FDA）批准了我们的先导化合物OMN6的快速通道名称这使我们能够加速开发改变游戏规则的抗感染药物，这些药物旨在快速有效而不引发抗菌素耐药性。

We are looking forward to obtaining Phase II results.' “The fast-track designation bring.

我们期待着取得第二阶段的成果。”“快速通道标志带来了。