Omnix Medical, a biopharmaceutical company developing next-generation anti-infectives for the treatment of life-threatening infections, today announced that the Company 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.

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 had been 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 resistances.

“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.

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About Omnix Medical
Omnix Medical was founded in 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 uses unique molecules to efficiently and selectively kill resistant bacterial strains without toxic effects. This mechanism, which is at the core of Omnix´ 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´ technology prevents the development of new resistances and is thus well positioned to become the first-line-treatment to win the war against AMR.

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 Gram-negative bacteria such as Acinetobacter baumannii.

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JERUSALEM, Israel, November 20, 2023 — Omnix Medical, a biopharmaceutical company developing next-generation anti-infectives for the treatment of life-threatening infections, today announced that the U.S. Food and Drug Administration (FDA) has approved a planned Phase II trial of the Company´s novel anti-infective OMN6.

The multinational, multicenter trial will assess the safety and pharmacokinetics of OMN6 in patients with hospital-acquired bacterial pneumonia (HABP) or ventilator-associated bacterial pneumonia (VABP) caused by Acinetobacter baumannii complex (ABC).

Omnix Medical´s lead compound OMN6 is a novel, first-in-class antimicrobial peptide (AMP) based on insect host defense peptides. Its mechanism of action (MoA) is based on a totally novel principle compared to conventional anti-infectives: the compound destroys bacterial cell membranes, enabling a fast and effective onset of action regardless of bacterial genotype or resistance phenotype.

In a randomized, double-blind, placebo-controlled, single ascending dose Phase I study with over 80 healthy volunteers, OMN6 has demonstrated excellent safety and tolerability at clinically significant dose levels. Moreover, complete clearance of the drug could be shown, allowing for multiple daily infusions as is common with anti-infective treatments.

“We are very pleased that the U.S. FDA has approved our planned Phase II study,” said Dr. Moshik Cohen-Kutner, CEO of Omnix Medical. “As we have seen very encouraging results in our previous Phase I trial, we hope that the Phase II data will confirm these data. This would be a key milestone in the development of a novel class of anti-infectives that are not associated with a development of antimicrobial resistance.”

Dr. Niv Bachnoff, CSO of Omnix Medical, added: “We look forward to initiating this Phase II trial in the coming months. Our goal is to provide a potent alternative to conventional anti-infectives and to save the lives of millions of patients worldwide who no longer respond to currently available antibiotics.”

About Omnix Medical
Omnix Medical was founded in 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 uses unique molecules to efficiently and selectively kill resistant bacterial strains without toxic effects. This mechanism, which is at the core of Omnix´ 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´ technology prevents the development of new resistances and is thus well positioned to become the first-line-treatment to win the war against AMR.

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 Gram-negative bacteria such as Acinetobacter baumannii.

Corporate Contacts
Moshik Cohen-Kutner, CEO
+972-50-8698218

Niv Bachnoff, CSO
+972-54-238-6023
contact@omnixmedical.com

Media Inquiries
akampion
Dr. Ludger Wess / Ines-Regina Buth
Managing Partners
info@akampion.com
Tel. +49 40 88 16 59 64 /
Tel. +49 30 23 63 27 68

Related Links
Twitter https://twitter.com/MedicalOmnix
LinkedIn http://linkedin.com/company/omnix-medical

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The post OMN6 – Omnix Medical’s Lead Antimicrobial Peptide Receives Notice of Allowance from the Indian Patent Office appeared first on Omnix Medical.

JERUSALEM, Israel, May 8th, 2023 — Omnix Medical, a biopharmaceutical company developing next-generation anti-infectives for the treatment of life-threatening infections, today announced positive top-line results from the Phase I clinical trial of its lead compound OMN6, an anti-infective with a completely novel mechanism of action. All endpoints were met: No severe or serious adverse events (SEs/SAEs) were observed at any dose level in the study while clinically meaningful levels of OMN6 were achieved in the blood and complete clearance of the drug was demonstrated, allowing for multiple daily infusions as is common with anti-infective treatments. 

The study, conducted in Groningen, The Netherlands, covered a total of 80 healthy volunteers, including a cohort of elderly patients, and was designed as a randomized, double-blind, placebo-controlled, single ascending dose study. Primary endpoints were safety and tolerability of single ascending i.v. doses of OMN6. The secondary endpoint was to evaluate the pharmacokinetics (PK) of OMN6 in the plasma of healthy young and elderly adult volunteers.

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 Gram-negative bacteria such as Acinetobacter baumannii. 

“We are very pleased with these results,” said Dr. Moshik Cohen-Kutner, CEO of Omnix Medical. “They demonstrate that our approach is safe and that the compound is well tolerated at clinically significant doses, even in the elderly. This is a very important milestone as the burden of antimicrobial resistance is estimated to be 4.95 million deaths per year worldwide.”

Dr. Niv Bachnoff, CSO of Omnix Medical, added: “This is a very important milestone on the way to establishing a new class of antibiotics that are orders of magnitude less likely to induce resistance, recrudescence or tolerance in bacterial pathogens. We are now looking forward to preparing a Phase II trial with OMN6 in the coming months.”

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About Omnix Medical

Omnix Medical was founded in 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 uses unique molecules to efficiently and selectively kill resistant bacterial strains without toxic effects. This mechanism, which is at the core of Omnix´ 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´ technology prevents the development of new resistances and is thus well positioned to become the first-line-treatment to win the war against AMR.  

Corporate Contacts

Moshik Cohen-Kutner, CEO
+972-50-8698218

Niv Bachnoff, CSO
+972-54-238-6023

contact@omnixmedical.com

Media Inquiries

akampion
Dr. Ludger Wess / Ines-Regina Buth 
Managing Partners
info@akampion.com
Tel. +49 40 88 16 59 64 /
Tel. +49 30 23 63 27 68

Related Links

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

The post Omnix Medical Announces Excellent Topline Data from the Phase I Clinical Trial of its Novel Anti-Infective OMN6 appeared first on Omnix Medical.

We are delighted to announce that Dr. Niv Bachnoff, our Chief Scientific Officer, has won the First Prize for Best Presentation in the Biotech & Pharmaceuticals category at the European Innovation Council’s Investor Day on Healthcare, which took place in Lisbon in November, presenting Omnix Medical to Investors and fellow EIC H2020 champions and raising awareness for the fight against AMR.

Omnix Medical is a clinical-stage biopharmaceutical company focused on developing innovative anti-infective drugs to combat the growing problem of Antimicrobial Resistance (AMR). Our goal is to offer safer and more effective treatments that are less prone to resistance, to effectively address the threat posed by AMR. We are dedicated to finding a solution to this pressing issue and are confident that our therapies will make a significant impact in the fight against AMR.

The post RECOGNITION AT EUROPEAN INNOVATION COUNCIL’S INVESTOR DAY appeared first on Omnix Medical.

The post STUDY: In Vitro and In Vivo Antimicrobial Activity of the Novel Peptide OMN6 against Multidrug-Resistant Acinetobacter baumannii appeared first on Omnix Medical.

Omnix Medical is pleased to announce the addition of two new peptide families – OMN50 and OMN70. 

At Omnix, we are working hard to build our clinical pipeline with new peptide-based drugs that address broad unmet medical needs. 

Using Omnix drug discovery platform to screen a wide-ranging array of peptides originating from marine organisms, insects and frogs, we identified these two new peptide families that demonstrate a great potential in targeting hard to treat bacterial pathogens. 

Two molecules, OMN51 and OMN71, have been advanced to Lead Optimization and Formulation stages of their development:

OMN51 is a new antimicrobial peptide (AMP) targeting Gram-negative bacteria like P. aeruginosa which causes recurrent and persistent infections in patients with Cystic Fibrosis (CF). Cycles of infection and hospitalization promote the development of resistance that significantly reduces treatment solutions.

OMN71 is a new antimicrobial peptide (AMP) targeting bacteria involved with skin infections in patients with Acne or Atopic-Dermatitis. When infections of the skin involve MRSA or P. Acnes high levels of resistance are present and treatment becomes hard and prolonged. 

Intensive and comprehensive preclinical research is being conducted at Omnix Medical Laboratories to bring OMN51 and OMN71 to clinical development in parallel with the filing of appropriate patent applications.

The Company’s lead compound, OMN6, is a first-in-class antimicrobial peptide for the treatment of life-threatening hospital acquired infections caused by Gram-negative bacteria.  OMN6 has been found to be highly effective on multidrug-resistant Acinetobacter baumannii (AB), especially Carbapenem-resistant AB (CRAB), the #1 priority pathogen according to the WHO/CDC. 

Recently, Omnix Medical initiated a Phase I clinical trial testing our lead molecule, OMN6, in a randomized, double-blind, placebo-controlled, single ascending dose trial assessing safety, tolerability, and pharmacokinetics in healthy subjects. The trial is conducted in Groningen, The Netherlands and results are expected by Q4 2022.

To learn more about the Omnix discovery pipeline, contact us at info@omnixmedical.com.

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JERUSALEM, Israel, April 12, 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 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.” 

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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. 

Corporate Contacts

Moshik Cohen-Kutner, CEO
+972-50-8698218

Niv Bachnoff, CSO
+ 972-54-238-6023

contact@omnixmedical.com

Media Inquiries

akampion
Dr. Ludger Wess / Ines-Regina Buth 
Managing Partners
info@akampion.com
Tel. +49 40 88 16 59 64
Tel. +49 30 23 63 27 68

Related Links

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

The post OMNIX MEDICAL STARTS PHASE I CLINICAL TRIAL OF NOVEL ANTI-INFECTIVE; FIRST HEALTHY VOLUNTEERS DOSED appeared first on Omnix Medical.

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.“

The post OMNIX MEDICAL ADVANCES NOVEL ANTI-INFECTIVE PROGRAM INTO CLINICAL DEVELOPMENT appeared first on Omnix Medical.

To encourage EU Member States to actively contribute to exchanges on AMR in the co-legislative process, the BEAM Alliance relies on a network of National Coordinators.

The aim is to encourage every state to put in place their own plan to combat AMR, in particular by supporting innovation.

Omnix Medical is pleased to share the work of its CSO, Niv Bachnoff, as a BEAM Alliance National Coordinator.

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