February 20, 2024
Designation underlines the need for novel, first-in-class antimicrobials for the treatment of infections with Gram-negative bacteria
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.
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