Omnix Medical Starts Phase I Clinical Trial of their Novel Antimicrobial Agent

 

New mechanism of action (MoA) addressing global increase of antimicrobial resistance (AMR) burden and shortage of potent anti-infectives

JERUSALEM, Israel, April XX, 2022 — 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 occurring mechanism of action (MoA) leading to 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 the 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. The antimicrobial peptide OMN6 targets Acinetobacter baumannii (AB). The Acinetobacter baumannii is an opportunistic bacterial pathogen that is becoming increasingly important for hospital-acquired infections. Types of infections due to Acinetobacter baumannij can include: pneumonia (commonly ventilator-associated), UTI, septicemia (serious blood infections), catheter-related infections, and traumatic wound infections. 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 in 2015 by Dr. Moshik Cohen-Kutner (CEO), Dr. Niv Bachnoff (CSO), and Rom Lakritz (CFO/COO) to address the urgent need for new life-saving antibiotics. They came up with their unique idea for their solution after analyzing the way in which the immune systems of insects act against infections, using unique molecules to efficiently and selectively kill resistant bacteria strains without toxic effects. This mechanism that kills bacteria upon contact has endured for over 200 million years and is the core of Omnix´s technology.

Omnix started off at the VLX Ventures incubator, which invested in the company with the Israel Innovation Authority. In 2020, Omnix Medical raised $8.5 million from Tal Capital, Entrée Capital, the CBG Group, Xenia Ventures, VLX Ventures, and with the support of the Israel Innovation Authority.

In addition, during 2020, Omnix received 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, joining the Israeli innovation Authority (IIA) which has been funding Omnix Medical’s activities since its inception.

The Company’s lead compound is being developed for the treatment of life-threatening hospital-acquired infections via systemic IV administration. It targets superbugs, such as Gram-negative, multidrug-resistant pathogens which belong to the so-called ESKAPE bacteria group, the most serious and urgent threats to public health.

For further information:

Email: info AT omnixmedical.com
https://omnixmedical.com/

Source:  Omnix Medical

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