Omnix Medical, a biopharmaceutical company developing next-generation anti-infectives for severe multidrug-resistant infections, has dosed first patients in a Phase II trial (NCT06087536) with its lead compound OMN6.

The first-in-class antimicrobial targets severe multidrug-resistant Acinetobacter baumannii infections associated with high mortality and limited treatment options. 

The patients were treated at Rabin Medical Center (Beilinson Hospital), Samson Assuta Ashdod University Hospital, and Shamir Medical Center in Israel.

The ongoing Phase IIa study is a prospective, multinational, multicenter, randomized, double-blind, placebo-controlled, dose-ranging trial evaluating OMN6 in patients with hospital-acquired bacterial pneumonia (HABP) or ventilator-associated bacterial pneumonia (VABP) caused by Acinetobacter baumannii complex (ABC), including carbapenem-resistant strains classified by the WHO as critical priority pathogens. 

The trial is designed to identify safe and well-tolerated doses and to assess the PK profile of OMN6 in patients.

OMN6 is being evaluated as a novel first-line treatment with a membrane-disrupting mechanism of action designed to address severe infections with high unmet medical need and limited available treatment options.

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

“The growing global spread of multidrug-resistant Gram-negative pathogens underscores the urgent need for novel anti-infective approaches with differentiated mechanisms of action,” added Prof. Kaye. 

Professor Yehuda Carmeli, MD, MPH, Head of the National Institute for Antibiotic Resistance and Infection Control, Tel Aviv Medical Center and a member of Omnix’s Clinical Advisory Board said, “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.” 

“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,” added Prof. Carmeli.

Dr. Moshik Cohen-Kutner ,Co-Founder & Chief Executive Officer of Omnix Medical said, “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,: added Dr. Kutner.