OMNIX MEDICAL ADVANCES NOVEL ANTI-INFECTIVE PROGRAM INTO CLINICAL DEVELOPMENT

Entirely novel therapeutic principle to combat alarming worldwide rise of antimicrobial resistance (AMR)

JERUSALEM, Israel, March 16, 2022 — Omnix Medical, a biopharmaceutical company developing next-generation anti-infectives for the treatment of life-threatening infections, today announced it received approval by Dutch authorities to initiate a Phase I clinical trial with its lead compound OMN6 in healthy volunteers. The trial will be conducted in Groningen, The Netherlands.

OMN6, the lead compound of Omnix, 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.

OMN6 will be evaluated in a randomized, double-blind, placebo-controlled, single ascending dose trial assessing safety, tolerability, and pharmacokinetics of single and repeat IV infusion of OMN6 in healthy subjects. Results are expected by Q4, 2022.

Based on the results from preclinical development, OMN6 has the potential to significantly reduce mortality in patients suffering from infections with A. baumannii, a life-threatening complication in hospitalized and intensive care patients undergoing anti-infective treatment. OMN6 is highly effective against a broad range of A. baumannii subtypes.

“We are very happy about the progress of our compound,” said Dr. Moshik Cohen-Kutner, CEO of Omnix Medical. “According to the latest estimates published in The Lancet, approximately 5 million deaths are associated with bacterial AMR every year, while available drugs are not sufficiently addressing the problem of increasing drug-resistance. It is our goal to improve on the standard of care for life-threatening infections with first in class anti-infectives leveraging a natural mechanism of action successfully established in insect immunity.”

Dr. Niv Bachnoff, CSO of Omnix Medical, added “It is time for action. The silent pandemic of AMR is a major global healthcare challenge with rippling effects around the world.“