Omnix Medical https://omnixmedical.com/ Fri, 10 May 2024 20:09:35 +0000 en-US hourly 1 https://wordpress.org/?v=6.7 https://omnixmedical.com/wp-content/uploads/2021/06/cropped-Omnix-Mood-Board-icon-52-32x32.png Omnix Medical https://omnixmedical.com/ 32 32 Safety and Pharmacokinetic Results from the First-in-Human Study with Intravenously Administered OMN6 (A Poster) https://omnixmedical.com/2024/05/10/safety_and_pharmacokinetic_results_from_the_first_in_human_study/ https://omnixmedical.com/2024/05/10/safety_and_pharmacokinetic_results_from_the_first_in_human_study/#respond Fri, 10 May 2024 20:08:04 +0000 https://omnixmedical.com/?p=2223 Safety and Pharmacokinetic Results from the First-in-Human Study with Intravenously Administered OMN6, a Novel Antimicrobial Peptide for Acinetobacter baumannii (AB), Conducted in Healthy Volunteers Access Full Poster  Background Serious Gram-negative bacterial infections, particularly those caused by Acinetobacter baumannii (AB), pose a significant global health threat due to increasing antibiotic resistance (1-2).  OMN6 is a novel, biochemically-engineered antimicrobial […]

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Safety and Pharmacokinetic Results from the First-in-Human Study with Intravenously Administered OMN6, a Novel Antimicrobial Peptide for Acinetobacter baumannii (AB), Conducted in Healthy Volunteers

 

Background

Serious Gram-negative bacterial infections, particularly those caused by Acinetobacter baumannii (AB), pose a significant global health threat due to increasing antibiotic resistance (1-2).  OMN6 is a novel, biochemically-engineered antimicrobial peptide with a unique and new mechanism of action, selective for Gram-negative bacteria with minimal potential to develop resistance (3-4).

Methods

In a randomized, double-blind dose escalation study, nine cohorts (per cohort 6 subjects on OMN6 and 2 subjects on placebo) of healthy young male and female adult volunteers, received daily doses from 7.5 to 300 mg OMN6, as a single, double or triple 3-hours infusions with a 5 hours wash-out period between subsequent infusions. Safety and tolerability assessments,  and pharmacokinetic blood sampling occurred at pre-defined timepoints. All blood samples for the pharmacokinetic evaluation were analyzed with a validated LC/MS/MS assay. All safety, tolerability and pharmacokinetic results were descriptively analyzed.

Results

There were no serious adverse events or premature drop-outs. All safety (vital signs, ECG, safety labs in blood and urine, physical examinations, local tolerability) and tolerability (adverse events) parameters did not show a dose or time dependent effect. Adverse events were mild and transient. All treatments were well tolerated.

Single infusions of OMN6 show dose (Cmax) or near dose (AUCinf) dependent pharmacokinetics. Upon single infusions, the half-life increases from 0.08h at 7.5 mg to about 0.9h at 80 and 100 mg. After two or three infusion periods, there were no indications of an accumulation of OMN6, and the pharmacokinetic behavior of OMN6 is not affected by the number of infusions. There are no indications of a gender dependent effect on the pharmacokinetics of OMN6.

Conclusion

OMN6, upon one, two or three subsequent infusion periods of 3 hours each and up to a maximum total daily dose of 300 mg, has a favorable safety, tolerability and pharmacokinetic profile in healthy young volunteers. The reached OMN6 exposures showed efficacy in pre-clinical infection models4. The results support further clinical development of OMN6 as a potential therapeutic option for Gram-Negative Pathogen AB infections.

References

  1. Centers for Disease Control and Prevention (2019). Antibiotic resistance threats in the US.
  2. Tacconelli E et al., Lancet Infect Dis. (2018), 18(3):318-327.
  3. Mandel S, et al. Sci Rep. (2021), 11(1):6603.
  4. Michaeli J, et al. Antibiotics (2022);11(9):1201.

 

 
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]]> https://omnixmedical.com/2024/05/10/safety_and_pharmacokinetic_results_from_the_first_in_human_study/feed/ 0 Omnix Medical Granted Fast-Track Designation by U.S. FDA for its Next-Generation Anti-Infective OMN6 https://omnixmedical.com/2024/02/20/omnix-medical-granted-fast-track-designation-by-u-s-fda-for-its-next-generation-anti-infective-omn6/ https://omnixmedical.com/2024/02/20/omnix-medical-granted-fast-track-designation-by-u-s-fda-for-its-next-generation-anti-infective-omn6/#respond Tue, 20 Feb 2024 06:03:00 +0000 https://omnixmedical.com/?p=2134 Designation underlines the need for novel, first-in-class antimicrobials for the treatment of infections with Gram-negative bacteria 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 […]

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]]> Designation underlines the need for novel, first-in-class antimicrobials for the treatment of infections with Gram-negative bacteria

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.

###

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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]]> https://omnixmedical.com/2024/02/20/omnix-medical-granted-fast-track-designation-by-u-s-fda-for-its-next-generation-anti-infective-omn6/feed/ 0 Omnix Medical Receives U.S. FDA Approval of a Phase II Trial of its Next-Generation Anti-Infective OMN6 https://omnixmedical.com/2023/11/20/omnix-medical-receives-u-s-fda-approval-of-a-phase-ii-trial-of-its-next-generation-anti-infective-omn6/ https://omnixmedical.com/2023/11/20/omnix-medical-receives-u-s-fda-approval-of-a-phase-ii-trial-of-its-next-generation-anti-infective-omn6/#respond Mon, 20 Nov 2023 18:28:00 +0000 https://omnixmedical.com/?p=2106 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 […]

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  • Phase I data show safety and tolerability at clinically significant dose levels
  • New class of anti-infectives to treat infections with Gram-negative bacteria

    • 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

    The post Omnix Medical Receives U.S. FDA Approval of a Phase II Trial of its Next-Generation Anti-Infective OMN6 appeared first on Omnix Medical.

    ]]>     https://omnixmedical.com/2023/11/20/omnix-medical-receives-u-s-fda-approval-of-a-phase-ii-trial-of-its-next-generation-anti-infective-omn6/feed/ 0     OMN6 – Omnix Medical’s Lead Antimicrobial Peptide Receives Notice of Allowance from the Indian Patent Office https://omnixmedical.com/2023/07/09/omn6-omnix-medicals-lead-antimicrobial-peptide-receives-notice-of-allowance-from-the-indian-patent-office/ https://omnixmedical.com/2023/07/09/omn6-omnix-medicals-lead-antimicrobial-peptide-receives-notice-of-allowance-from-the-indian-patent-office/#respond Sun, 09 Jul 2023 18:40:48 +0000 https://omnixmedical.com/?p=2051 We are here to announce that the Indian Patent Office has issued a Notice of Allowance for Omnix Medical’s lead antimicrobial peptide for the treatment of infectious diseases. This pivotal achievement signifies that OMN6, developed with a commitment to revolutionize infectious disease treatment, has met the stringent criteria required for intellectual property protection. Importantly, the […]

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

    ]]>

    We are here to announce that the Indian Patent Office has issued a Notice of Allowance for Omnix Medical’s lead antimicrobial peptide for the treatment of infectious diseases. This pivotal achievement signifies that OMN6, developed with a commitment to revolutionize infectious disease treatment, has met the stringent criteria required for intellectual property protection.

    Importantly, the Notice of Allowance follows the patent protection previously granted to OMN6 in several other major international markets, including the United States, European Union, China, Australia, and Japan. The repeated validation from patent offices worldwide testifies to the unique, innovative, and significant nature of our work in fighting infectious diseases.

    Our dedicated team of scientists has invested countless hours in the development of this peptide, with the goal of delivering a novel, effective, and accessible solution for AMR and for the treatment of infectious diseases globally.

    With this Notice of Allowance, the intellectual property for our lead peptide is officially recognized and protected until 2037. This provides our company with the exclusive rights to further develop and commercialize our pioneering antimicrobial peptide. It also ensures that we can continue our vital work to advance this treatment without the fear of any patent infringement.

    As we move forward, we remain committed to pushing the boundaries of biotechnology to improve healthcare outcomes worldwide. We will keep you updated as we embark on the next clinical phase of our journey.

    Thank you for your continued support and trust in our mission.

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

    ]]>     https://omnixmedical.com/2023/07/09/omn6-omnix-medicals-lead-antimicrobial-peptide-receives-notice-of-allowance-from-the-indian-patent-office/feed/ 0     Omnix Medical Announces Excellent Topline Data from the Phase I Clinical Trial of its Novel Anti-Infective OMN6 https://omnixmedical.com/2023/05/10/omnix-medical-announces-excellent-topline-data-from-the-phase-i-clinical-trial-of-its-novel-anti-infective-omn6/ https://omnixmedical.com/2023/05/10/omnix-medical-announces-excellent-topline-data-from-the-phase-i-clinical-trial-of-its-novel-anti-infective-omn6/#respond Wed, 10 May 2023 06:43:01 +0000 https://omnixmedical.com/?p=2025 OMN6 demonstrates safety and tolerability at clinically significant dose levels   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. […]

    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.

    ]]>     OMN6 demonstrates safety and tolerability at clinically significant dose levels  

    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.”

    ###

    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.

    ]]>     https://omnixmedical.com/2023/05/10/omnix-medical-announces-excellent-topline-data-from-the-phase-i-clinical-trial-of-its-novel-anti-infective-omn6/feed/ 0     RECOGNITION AT EUROPEAN INNOVATION COUNCIL’S INVESTOR DAY https://omnixmedical.com/2022/11/30/recognition-at-european-innovation-council/ Wed, 30 Nov 2022 05:21:00 +0000 https://omnixmedical.com/?p=1972 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 […]

    The post RECOGNITION AT EUROPEAN INNOVATION COUNCIL’S INVESTOR DAY 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.

    ]]>         STUDY: In Vitro and In Vivo Antimicrobial Activity of the Novel Peptide OMN6 against Multidrug-Resistant Acinetobacter baumannii https://omnixmedical.com/2022/09/05/study_in_vitro_and_in_vivo_antimicrobial_activity_of_the_novel_peptide_omn6/ Mon, 05 Sep 2022 16:05:14 +0000 https://omnixmedical.com/?p=1873 The rapid worldwide spread of antimicrobial resistance (AMR) underscores the significant need for the development of innovative treatments to fight multidrug-resistant bacteria.  Our Scientists at Omnix Medical have published a study demonstrating the potent antimicrobial activity of the novel peptide OMN6 against a wide array of drug-resistant Acinetobacter baumannii.  Results point to OMN6 as a novel antimicrobial […]

    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.

    ]]>

    The rapid worldwide spread of antimicrobial resistance (AMR) underscores the significant need for the development of innovative treatments to fight multidrug-resistant bacteria. 

    Our Scientists at Omnix Medical have published a study demonstrating the potent antimicrobial activity of the novel peptide OMN6 against a wide array of drug-resistant Acinetobacter baumannii. 

    Results point to OMN6 as a novel antimicrobial agent targeting the most troubling bacteria with a novel mechanism of action, positioning our technology as the potential SoC to treat life-threatening infections caused by MDR bacteria. READ STUDY PUBLISHED 5 September 2022.

    In Vitro and In Vivo Antimicrobial Activity of the Novel Peptide OMN6 against Multidrug-Resistant Acinetobacter baumanniiDownload

     

    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 ANNOUNCES THE ADDITION OF TWO NEW PEPTIDE FAMILIES – OMN50 AND OMN70 https://omnixmedical.com/2022/07/22/omnix-medical-announces-the-addition-of-two-new-peptide-families-omn50-and-omn70/ https://omnixmedical.com/2022/07/22/omnix-medical-announces-the-addition-of-two-new-peptide-families-omn50-and-omn70/#respond Fri, 22 Jul 2022 07:03:12 +0000 https://omnixmedical.com/?p=1807 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 […]

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    ]]>

    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.

    The post OMNIX MEDICAL ANNOUNCES THE ADDITION OF TWO NEW PEPTIDE FAMILIES – OMN50 AND OMN70 appeared first on Omnix Medical.

    ]]>     https://omnixmedical.com/2022/07/22/omnix-medical-announces-the-addition-of-two-new-peptide-families-omn50-and-omn70/feed/ 0     OMNIX MEDICAL STARTS PHASE I CLINICAL TRIAL OF NOVEL ANTI-INFECTIVE; FIRST HEALTHY VOLUNTEERS DOSED https://omnixmedical.com/2022/04/12/omnix-medical-starts-phase-i-clinical-trial-of-novel-anti-infective-first-healthy-volunteers-dosed/ https://omnixmedical.com/2022/04/12/omnix-medical-starts-phase-i-clinical-trial-of-novel-anti-infective-first-healthy-volunteers-dosed/#respond Tue, 12 Apr 2022 14:58:24 +0000 https://omnixmedical.com/?p=1693 New mechanism of action (MoA) addressing global increase of antimicrobial resistance (AMR) burden and shortage of potent anti-infectives  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 […]

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

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

    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.” 

    ###

    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.

    ]]>     https://omnixmedical.com/2022/04/12/omnix-medical-starts-phase-i-clinical-trial-of-novel-anti-infective-first-healthy-volunteers-dosed/feed/ 0     OMNIX MEDICAL ADVANCES NOVEL ANTI-INFECTIVE PROGRAM INTO CLINICAL DEVELOPMENT https://omnixmedical.com/2022/03/16/omnix-medical-advances-novel-anti-infective-program-into-clinical-development/ https://omnixmedical.com/2022/03/16/omnix-medical-advances-novel-anti-infective-program-into-clinical-development/#respond Wed, 16 Mar 2022 22:17:00 +0000 https://omnixmedical.com/?p=1683 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 […]

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

    ]]>     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.“

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

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