Omnix Medical Starts Phase I Clinical Trial of Novel Anti-Infective; First Healthy Volunteers Dosed
– New mechanism of action (MoA) addressing global increase of antimicrobial resistance (AMR) burden and shortage of potent anti-infectives
Omnix Medical, a biopharmaceutical company developing next-generation anti-infectives for the treatment of life-threatening infections, today announced the initiation of a Dutch Phase I clinical trial with its lead compound OMN6. Since March 28, 2022, six healthy volunteers have been administered the novel antimicrobial, which is based on a naturally occuring mechanism of action (MoA) leading to a targeted, effective destruction of the cell membrane of pathogens. The trial is being conducted in Groningen, The Netherlands. OMN6 is being evaluated in a randomized, double-blind, placebo-controlled, single ascending dose trial assessing safety, tolerability, and pharmacokinetics of single and repeat IV infusion of the compound in healthy subjects. Results are expected by Q4, 2022.
OMN6 is a first-in-class antimicrobial peptide for the treatment of life-threatening infections caused by Gram-negative bacteria. In 2017, OMN6 has been designated a Qualified Infectious Disease Product (QIDP) by the U.S. FDA. In 2020, Omnix secured over €10M in funding for the clinical development of OMN6 from the European Innovation Committee (EIC) H2020, with a top 1-percentile program ranking. In 2021, the U.S. National Institutes of Health (NIH) awarded a grant for the development of OMN6 targeting infections with Acinetobacter baumannii (A. baumannii), joining the Israeli Innovation Authority (IIA) which has been funding Omnix Medical’s activities since inception. Recent publications summarizing the most comprehensive research on the burden of antimicrobial resistance (AMR) to date estimate 4.95 million deaths associated with bacterial AMR per year, with worldwide prevalence.
In-vivo preclinical trials with OMN6 demonstrated a significant reduction of mortality in infections with A. baumannii. OMN6 is highly effective against a broad range of
A. baumannii subtypes that are involved in life-threatening complications in hospitalized and intensive care patients.
“The successful dosing of these first six individuals is a major milestone for our entire team,” said Dr. Moshik Cohen-Kutner, CEO of Omnix Medical. “With our new approach, we significantly lower the threat of antimicrobial resistance (AMR) development. Our compound physically destroys the pathogen´s cell membrane upon contact, causing immediate eradication of the pathogen and leaving no chance for the emergence of resistance.”
Dr. Niv Bachnoff, CSO of Omnix Medical, added “We are thrilled about the progress of our first clinical trial. Our goal is to offer patients and healthcare systems worldwide a potent alternative to available antimicrobials, which have increasingly lost their impact due to the alarming spread of AMR.”
About Omnix Medical
Omnix Medical was founded on 2015 to address the urgent unmet need for new life-saving anti-infective drugs. Omnix´ proprietary technology eliminates bacteria by mimicking the innate immune system of insects which is using unique molecules to efficiently and selectively kill resistant bacterial strains without toxic effects. This mechanism kills bacteria upon contact, it has endured for over 200 million years of evolution and is the core of Omnix´ technology. The Company’s lead compound is being developed for the treatment of life-threatening hospital-acquired infections (HIA) and has shown significantly higher potency than currently available antibiotics. Most importantly, Omnix´ technology prevents the development of new resistances and thus well positioned to become the next Standard of Care to win the war against AMR. http://www.omnixmedical.com/