You are currently viewing Omnix Medical Granted U.S. FDA Fast-Track for its Next-Generation Anti-Infective OMN6

Omnix Medical, a biopharmaceutical company developing next-generation anti-infectives for the treatment of life-threatening infections, has received fast-track designation for its novel anti-infective OMN6 from the U.S. Food and Drug Administration (FDA). Fast-track expedited review is designated to investigational drugs that treat a serious or life-threatening condition and fill an unmet medical need. The purpose is to get important new drugs to the patient earlier. Fast Track addresses a broad range of serious conditions.

A drug that receives Fast Track Designation is entitled to more frequent meetings with FDA to discuss the drug’s development plan and ensure collection of appropriate data needed to support drug approval, more frequent written communication from the FDA about such things as the design of the proposed clinical trials and use of biomarkers, eligibility for Accelerated Approval and Priority Review, if relevant criteria are met and possibly best of all, Rolling Review, which means that a drug company can submit completed sections of its Biologic License Application (BLA) or New Drug Application (NDA) for review by FDA, rather than waiting until every section of the NDA is completed before the entire application can be reviewed. BLA or NDA review usually does not begin until the drug company has submitted the entire application to the FDA.

OMN6 is Omnix Medical´s lead compound and a novel, first-in-class antimicrobial peptide (AMP) based on insect host defense peptides. Its mechanism of action (MoA) fundamentally differs from conventional anti-infectives by physically destroying bacterial cell membranes and allowing a fast and effective onset of action regardless of bacterial genotype or resistance phenotype.

In November 2023, Omnix Medical was granted an IND for a Phase II trial of OMN6 in patients with hospital-acquired bacterial pneumonia (HABP) or ventilator-associated bacterial pneumonia (VABP) caused by Acinetobacter baumannii complex (ABC). Both are life-threatening infections that currently lack fast and effective treatments, most of which fall short due to antimicrobial resistance.

“We are excited that the U.S. FDA has granted fast-track designation for our lead compound OMN6,” said Dr. Moshik Cohen-Kutner, CEO of Omnix Medical. “This allows us to accelerate the development of game-changing anti-infectives that are designed to be fast-acting and effective without triggering antimicrobial resistances. We are looking forward to obtaining Phase II results.”

“The fast-track designation brings us one step closer to saving the lives of patients with life-threatening hospital-acquired bacterial pneumonia (HABP) or ventilator-associated bacterial pneumonia (VABP) that do not respond to conventional antibiotics and currently have no further therapeutic options,” added Niv Bachnoff, CSO of Omnix Medical.

About Omnix Medical

Omnix Medical was founded in 2015 by Dr. Moshik Cohen-Kutner (CEO) and Dr. Niv Bachnoff (CSO) to address the urgent unmet need for new life-saving anti-infective drugs. Omnix HQ and Labs are located in Jerusalem. The company employs sixteen employees advancing in-house R&D as well as closely directing studies with top-tier international CROs.

Omnix Medical´s proprietary technology eliminates bacteria by mimicking the innate immune system of insects which uses unique molecules to efficiently and selectively kill resistant bacterial strains without toxic effects. This mechanism, which is at the core of Omnix Medical´s technology, kills bacteria upon contact and has successfully evolved over 200 million years. 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 treatments. Most importantly, Omnix Medical´s technology prevents the development of new resistances and is thus well positioned to become the first-line-treatment to win the war against AMR.

Omnix Medical started 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.

Some very key people in the pharma industry are on Omnix Medical’s advisory board, such as Prof. Roger D. Kornberg – Nobel Prize Laureate 2006, chemistry. Stanford School of Medicine, Prof. Yehuda Carmeli, MD – Head of the Israeli National Center for Antibiotic Resistance, and Dr. Yafit Stark – Former Chairperson. for Teva – VP Global Clinical Adviser. Clinical Development Strategy at Omnix Medical.

In addition, during 2020, Omnix Medical 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.

About OMN6

OMN6 is a novel, first-in-class antimicrobial peptide (AMP) based on insect host defense peptides. Its mechanism of action (MoA) is based on disruption of bacterial cell membranes and is therefore effective regardless of bacterial genotype or resistance phenotype, and unlike conventional bacteriostatic antibiotics, it is fast-acting and bactericidal. OMN6 has been optimized from the original AMP by Omnix Medical´s proprietary technology to exhibit not only remarkable efficacy, potency, and safety, but also high stability while maintaining bioactivity. As a result, Omnix Medical believes that its novel peptides can be considered a new class of antimicrobial drugs. OMN6, the Company’s lead compound, is intended for the treatment of life-threatening infections caused by superbugs, such as Gram-negative, multi-drug-resistant bacteria such as Acinetobacter baumannii.

Corporate Contacts

Moshik Cohen-Kutner, CEO    Tel: +972-50-8698218
Niv Bachnoff,                    CSO     Tel +972-54-238-6023 Email: contact AT omnixmedical.com

RelatedLinks

http://www.omnixmedical.com/
Twitter https://twitter.com/MedicalOmnix
LinkedIn http://linkedin.com/company/omnix-medical

 

About JLM- BioCity

News on the many life science and healthcare companies in the Jerusalem area can be seen at https://jlm-biocity.org/jlm-biocity-innovations/

JLM-BioCity is a non-profit organization focused on developing and excelling Jerusalem’s bio-community.

We invite you, researcher, professional, investor, and executive to become part of our vision, in building Jerusalem’s Biomed eco-system.

If you want your company featured in our blogs, news releases, please contact: info AT jlm-biocity.org