Omnix Medical has moved its experimental antibiotic OMN6 into Phase II testing, marking a key step in the fight against some of the world’s most dangerous drug-resistant infections.

 

The biopharmaceutical company said the first patients have now been dosed in a Phase II trial of OMN6, a first-in-class antimicrobial designed to target severe multidrug-resistant Acinetobacter baumannii infections — pathogens linked to high mortality rates and few remaining treatment options. 

 

Patients are being treated across Rabin Medical Center (Beilinson Hospital), Samson Assuta Ashdod University Hospital, and Shamir Medical Center in Israel.

 

The randomized, double-blind, placebo-controlled Phase IIa study is being conducted across multiple countries and centers. 

 

It is evaluating OMN6 in hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP) caused by Acinetobacter baumannii complex, including carbapenem-resistant strains classified by the WHO as critical priority pathogens. The trial aims to determine safe and tolerable doses while also assessing pharmacokinetics in infected patients.

 

OMN6 represents a new class of antimicrobial strategy, built around a membrane-disrupting approach designed to physically eliminate bacteria rather than inhibit them through conventional biochemical pathways.

 

“Mortality rates in critically ill patients infected with carbapenem-resistant Acinetobacter baumannii can reach up to 60%, while treatment options remain extremely limited. 

 

"The WHO has classified Acinetobacterbaumannii as a critical priority pathogen as it causes some of the most difficult multidrug-resistant infections in intensive care medicine worldwide,” said Professor Keith Kaye, 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 growing global spread of multidrug-resistant Gram-negative pathogens underscores the urgent need for novel anti-infective approaches with differentiated mechanisms of action.”

 

“What makes OMN6 particularly interesting is its differentiated membrane-disrupting mechanism of action, which is specifically designed to selectively target bacterial membranes and rapidly destroy them,” said Professor Yehuda Carmeli, Head of the National Institute for Antibiotic Resistance and Infection Control, Tel Aviv Medical Center and a member of Omnix’s Clinical Advisory Board. 

 

“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.”

 

For Omnix Medical, the milestone of dosing the first patient signals a transition from early development into clinical proof-of-concept territory.

 

“Dosing the first patient in our Phase II study marks a major milestone for Omnix Medical and advances OMN6 further toward clinical proof-of-concept,” said Moshik Cohen-Kutner,Co-Founder & Chief Executive Officer of Omnix Medical. 

 

“OMN6 was engineered to selectively bind to bacterial membranes and rapidly destabilize them, leading to bacterial cell death while minimizing the potential for resistance development. 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.”

 

OMN6 is a fast-acting antimicrobial peptide derived from insect-based natural peptides, designed to form pores in bacterial membranes and cause direct physical destruction of pathogens. It targets multidrug-resistant Gram-negative bacteria, including carbapenem-resistant Acinetobacter baumannii (CRAB), and is now being tested in patients following successful Phase I results.

 

The Phase II study will determine whether this novel “physical destruction” approach can translate into meaningful clinical outcomes for some of the most difficult-to-treat infections in modern medicine.