Omnix Medical, a biopharmaceutical company focused on developing next-generation anti-infectives for severe multidrug-resistant infections, has announced that the first patients have been dosed in its Phase 2 clinical trial (NCT06087536) evaluating OMN6, its lead investigational antimicrobial compound. The patients were treated at Rabin Medical Center (Beilinson Hospital), Samson Assuta Ashdod University Hospital and Shamir Medical Center in Israel.

The ongoing Phase 2a study is a prospective, multinational, multicentre, randomised, double-blind, placebo-controlled and dose-ranging trial assessing OMN6 in patients suffering from Hospital-Acquired Bacterial Pneumonia (HABP) or Ventilator-Associated Bacterial Pneumonia (VABP) caused by Acinetobacter Baumannii Complex (ABC), including carbapenem-resistant strains identified by the World Health Organisation as critical priority pathogens.

The study is designed to determine safe and well-tolerated dose levels while evaluating the pharmacokinetic profile of OMN6 in patients. The investigational therapy is being studied as a potential first-line treatment with a membrane-disrupting mechanism of action aimed at addressing severe infections with high unmet medical needs and limited therapeutic options.

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 Medical’s Clinical Advisory Board, highlighted the urgent need for new treatments, noting that mortality rates among critically ill patients infected with carbapenem-resistant Acinetobacter baumannii can reach up to 60 percent. He added that the global spread of multidrug-resistant Gram-negative pathogens underscores the need for anti-infective therapies with differentiated mechanisms of action.

Professor Yehuda Carmeli, 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, said OMN6’s membrane-disrupting mechanism is specifically designed to selectively target bacterial membranes and rapidly destroy them. He noted that innovative antimicrobial peptides such as OMN6 may offer an important therapeutic strategy against severe Acinetobacter infections, where resistance continues to rise and treatment options remain limited.

Dr. Moshik Cohen-Kutner, Co-founder and Chief Executive Officer of Omnix Medical, described the dosing of the first patient as a major milestone for the company and an important step toward achieving clinical proof-of-concept for OMN6. He said the compound was engineered to selectively bind to bacterial membranes and rapidly destabilise them, causing bacterial cell death while minimising the potential for resistance development.

OMN6 is a first-in-class Antimicrobial Peptide (AMP) developed to rapidly create pores in bacterial membranes, leading to the direct physical destruction of pathogens. The therapy targets multidrug-resistant Gram-negative bacteria, including Carbapenem-Resistant Acinetobacter Baumannii (CRAB), and is derived from naturally occurring insect antimicrobial peptides. Following successful completion of Phase 1 development, the compound is now advancing through Phase 2 clinical evaluation.

Founded in 2015, Omnix Medical focuses on addressing the global challenge of drug-resistant bacterial infections. The company has received support from the Israeli Innovation Authority, funding through the European Union’s EIC Accelerator/Horizon 2020 programme, and research grants from the US National Institutes of Health (NIH) to advance the development of OMN6.