Omnix Medical Initiates Phase II Trial of OMN6 for Drug-Resistant Acinetobacter baumannii Infections
Key Insights
Omnix Medical (search) has dosed the first patients in a Phase II trial of OMN6, a first-in-class antimicrobial targeting severe multidrug-resistant Acinetobacter baumannii (search) infections with mortality rates up to 60%.
OMN6 employs a novel membrane-disrupting mechanism that rapidly forms pores in bacterial membranes (search), leading to direct physical destruction of pathogens while minimizing resistance development potential.
The Phase IIa study is a randomized, double-blind, placebo-controlled trial evaluating OMN6 in patients with hospital-acquired or ventilator-associated bacterial pneumonia (search) caused by carbapenem-resistant strains.
Omnix Medical (search) has announced the dosing of first patients in a Phase II clinical trial of OMN6, a first-in-class antimicrobial peptide designed to combat life-threatening multidrug-resistant Acinetobacter baumannii (search) infections. The patients were treated at three Israeli medical centers: Rabin Medical Center (Beilinson Hospital), Samson Assuta Ashdod University Hospital (search), and Shamir Medical Center (search).
Novel Mechanism Targets Critical Priority Pathogen
OMN6 represents a breakthrough approach in treating severe infections caused by Acinetobacter baumannii (search) complex, including carbapenem-resistant strains classified by the WHO as critical priority pathogens. The compound employs a membrane-disrupting mechanism of action that rapidly forms pores in bacterial membranes (search), leading to direct physical destruction of the pathogens.
"Mortality rates in critically ill patients infected with carbapenem-resistant Acinetobacter baumannii (search) can reach up to 60%, while treatment options remain extremely limited," said Professor Keith Kaye MD, MPH, Chief of the Division of Allergy, Immunology and Infectious Diseases at Rutgers Robert Wood Johnson Medical School and a member of Omnix's Clinical Advisory Board. "The WHO has classified Acinetobacter baumannii as a critical priority pathogen as it causes some of the most difficult multidrug-resistant infections (search) in intensive care medicine worldwide."
Phase II Trial Design and Objectives
The ongoing Phase IIa study (NCT06087536) is a prospective, multinational, multicenter, randomized, double-blind, placebo-controlled, dose-ranging trial. The study evaluates OMN6 in patients with hospital-acquired bacterial pneumonia (search) (HABP) or ventilator-associated bacterial pneumonia (search) (VABP) caused by Acinetobacter baumannii (search) complex, including carbapenem-resistant strains. The trial is designed to identify safe and well-tolerated doses and assess the pharmacokinetic profile of OMN6 in patients.
Differentiated Therapeutic Strategy
Professor Yehuda Carmeli, MD, MPH, Head of the National Institute for Antibiotic Resistance and Infection Control at Tel Aviv Medical Center and a member of Omnix's Clinical Advisory Board, emphasized the compound's unique properties. "What makes OMN6 particularly interesting is its differentiated membrane-disrupting mechanism of action, which is specifically designed to selectively target bacterial membranes (search) and rapidly destroy them," he said. "In severe Acinetobacter infections, where treatment options remain extremely limited and resistance development continues to increase globally, innovative antimicrobial peptides such as OMN6 with a differentiated mechanism of action may offer an important new therapeutic strategy."
Engineered Antimicrobial Peptide Technology
OMN6 is derived from naturally occurring insect-derived antimicrobial peptides and has been engineered for high selectivity toward bacterial membranes (search). The compound binds specifically to the unique lipid composition of bacterial membranes and rapidly forms pores that destabilize and destroy them, leading to rapid bacterial death. Its engineered stability and ability to avoid enzymatic degradation enable shorter treatment durations and minimize the risk of resistance development.
"OMN6 was engineered to selectively bind to bacterial membranes (search) and rapidly destabilize them, leading to bacterial cell death while minimizing the potential for resistance development," said Dr. Moshik Cohen-Kutner, Co-Founder & Chief Executive Officer of Omnix Medical (search). "We believe this novel mechanism could represent a promising new therapeutic approach for patients suffering from life-threatening multidrug-resistant Gram-negative infections with very limited available treatment options."
Company Background and Support
Founded in 2015, Omnix Medical (search) has received significant support for its antimicrobial development programs. The company has been backed by the Israeli Innovation Authority, awarded a competitive EIC Accelerator/Horizon 2020 grant from the European Union, and received research funding from the U.S. National Institutes of Health (NIH) to advance OMN6. Following successful Phase I development, the compound is now being evaluated in the ongoing Phase II clinical study.