Omnix Medical https://omnixmedical.com/ Tue, 14 Jul 2026 13:25:56 +0000 en-US hourly 1 https://wordpress.org/?v=7.0.1 https://omnixmedical.com/wp-content/uploads/2021/06/cropped-Omnix-Mood-Board-icon-52-32x32.png Omnix Medical https://omnixmedical.com/ 32 32 Omnix Medical Launches New Horizon Europe PEPTAMR Infectious Disease Consortium https://omnixmedical.com/2026/07/14/omnix-medical-launches-new-horizon-europe-peptamr-infectious-disease-consortium/ https://omnixmedical.com/2026/07/14/omnix-medical-launches-new-horizon-europe-peptamr-infectious-disease-consortium/#respond Tue, 14 Jul 2026 13:21:21 +0000 https://omnixmedical.com/?p=2746 — EUR ~8M grant supports the late-stage clinical development of Omnix’s antimicrobial OMN6 — Leading European partners join forces to advance OMN6 for the treatment of life-threatening hospital-acquired infections   JERUSALEM, Israel, July 13, 2026 — Omnix Medical, a biopharmaceutical company developing next-generation anti-infectives for the treatment of life-threatening infections, today announced the launch of […]

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— EUR ~8M grant supports the late-stage clinical development of Omnix’s antimicrobial OMN6

— Leading European partners join forces to advance OMN6 for the treatment of life-threatening hospital-acquired infections

 

JERUSALEM, Israel, July 13, 2026 — Omnix Medical, a biopharmaceutical company developing next-generation anti-infectives for the treatment of life-threatening infections, today announced the launch of the PEPTAMR consortium, bringing together leading European clinical, scientific, and academic partners to accelerate the late-stage clinical development of OMN6, its lead antimicrobial peptide targeting resistant hospital-acquired infections (HAIs), including carbapenem-resistant Acinetobacter baumannii (CRAB), a WHO critical-priority pathogen associated with mortality rates of up to 60% and severely limited treatment options.

The PEPTAMR consortium has been awarded a EUR ~8M grant under the European Union’s Horizon Europe Research and Innovation Program “Boosting the translation of biotech research into innovative health therapies – HORIZON-HLTH-2025-01”. The consortium’s goal is to advance the PEPTAMR project, titled “Biomimetic antimicrobial peptide inspired by insects to combat multidrug-resistant Acinetobacter baumannii.”

The new consortium brings together leading European expertise across infectious diseases, translational science, regulatory science and multinational clinical research. By combining these complementary capabilities within a single program, the consortium aims to efficiently advance OMN6 through late-stage clinical development and achieve regulatory readiness for Phase III. OMN6 is currently being evaluated in a Phase II clinical trial enrolling patients with severe Acinetobacter baumannii infections.

Consortium partners include:

 Omnix Medical (Israel) – Project coordinator

 Medical University of Vienna (Austria)

 National and Kapodistrian University of Athens (Greece)

 Ecraid – European Clinical Research Alliance on Infectious Diseases (The Netherlands)

 Vivexia (France)

Planned activities include accelerated Phase II patient recruitment across Europe, complementary PK/PD studies, infection models to optimize dosing and evaluate additional indications such as sepsis, a lung penetration study in healthy volunteers, and development of a stable, scalable GMP-ready formulation to support late-stage clinical development.

“This is the second time Omnix’s OMN6 program has been funded by a HORIZON grant, underscoring the critical importance of our molecule as the novel first-line treatment for life-threatening infections” said Dr. Moshik Cohen-Kutner, Co-founder and Chief Executive Officer of Omnix Medical. “PEPTAMR enables us to combine the strengths of experienced European partners and ultimately shorten time-to-market for OMN6.”

“We are proud to lead a multidisciplinary European consortium dedicated to bringing innovative therapies to patients with life-threatening multidrug-resistant infections.

PEPTAMR is designed to support Europe’s broader efforts to combat antimicrobial resistance,” added Dr. Niv Bachnoff, Co-founder and Chief Scientific Officer of Omnix Medical. “Successful development of OMN6 will have a significant impact, as A. baumannii infections are associated with healthcare costs running into billions of euros annually across Europe.”

“The ambitious PEPTAMR consortium offers a promising new approach to tackling multidrug-resistant infections. By bringing together scientific, clinical and industry expertise from across Europe, we have the opportunity to turn evidence into meaningful outcomes for patients, healthcare systems, and public health,” said Ecraid’s Senior Communications Officer, Adelina Prioteasa. “Breakthroughs in the fight against antimicrobial resistance can only make a difference if they are seen, understood, and adopted. Ecraid is proud to bring its expertise to the PEPTAMR consortium. We aim to ensure that the project’s results and progress are widely shared with the scientific and healthcare communities, and that they deliver a lasting impact on the fight against antimicrobial resistance,” she added.

OMN6 is a first-in-class, fast-acting antimicrobial peptide (AMP) with a novel mechanism of action designed to physically destroy bacterial cell membranes. The compound targets multidrug-resistant Gram-negative pathogens, including carbapenem-resistant Acinetobacter baumannii (CRAB), and is based on naturally occurring insect-derived antimicrobial peptides. OMN6 addresses severe infections with high unmet medical need and limited treatment options.

About Horizon Europe
Horizon Europe is the European Union’s key funding program for research and innovation, with a budget of €93.5 billion for the period 2021–2027. Its health program is the EU’s flagship research and innovation initiative for collaborative health projects, supporting the development of innovative diagnostics, therapeutics, and medical technologies. It strengthens healthcare systems, helps translate scientific excellence into real-world impact and supports and implements EU policies while addressing global challenges. Horizon Europe supports the creation and dissemination of excellent knowledge and technologies and contributes to jobs, economic growth, and a stronger European Research Area.

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Omnix Medical Announces First Patient Dosed in Phase II Trial of Antimicrobial Lead Compound OMN6 https://omnixmedical.com/2026/07/08/omnix-medical-announces-first-patient-dosed-in-phase-ii-trial-of-antimicrobial-lead-compound-omn6/ https://omnixmedical.com/2026/07/08/omnix-medical-announces-first-patient-dosed-in-phase-ii-trial-of-antimicrobial-lead-compound-omn6/#respond Wed, 08 Jul 2026 07:08:10 +0000 https://omnixmedical.com/?p=2733 — Novel mechanism of action based on the direct physical elimination of pathogenic bacteria — First-in-class treatment of life-threatening, drug-resistant Acinetobacter baumannii infections advancing toward Phase II clinical proof-of-concept JERUSALEM, Israel, May, 2026 — Omnix Medical, a biopharmaceutical company developing next-generation anti-infectives for severe multidrug-resistant infections, announced today that the first patient in a Phase […]

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— Novel mechanism of action based on the direct physical elimination of pathogenic bacteria

— First-in-class treatment of life-threatening, drug-resistant Acinetobacter baumannii infections advancing toward Phase II clinical proof-of-concept

JERUSALEM, Israel, May, 2026 — Omnix Medical, a biopharmaceutical company developing next-generation anti-infectives for severe multidrug-resistant infections, announced today that the first patient in a Phase II trial (NCT06087536) has been dosed with its lead compound OMN6, a first-in-class antimicrobial targeting severe multidrug-resistant Acinetobacter baumannii infections associated with high mortality and limited treatment options. The patient was treated at Rabin Medical Center, Israel.

The ongoing Phase IIa study is a prospective, multinational, multicenter, randomized, double-blind, placebo-controlled, dose-ranging trial evaluating OMN6 in patients with hospital-acquired bacterial pneumonia (HABP) or ventilator-associated bacterial pneumonia (VABP) caused by Acinetobacter baumannii complex (ABC), including carbapenem-resistant strains classified by the WHO as critical priority pathogens. The trial is designed to identify safe and well-tolerated doses and to assess the PK profile of OMN6 in patients.

OMN6 is being evaluated as a novel first-line treatment with a membrane-disrupting mechanism of action designed to address severe infections with high unmet medical need and limited available treatment options.

“Mortality rates in critically ill patients infected with carbapenem-resistant Acinetobacter baumannii can reach up to 60%, while treatment options remain extremely limited. The WHO has classified Acinetobacter baumannii as a critical priority pathogen as it causes some of the most difficult multidrug-resistant infections in intensive care medicine worldwide,” said Professor Keith Kaye MD, MPH, Chief of the Division of Allergy, Immunology and Infectious Diseases at Rutgers Robert Wood Johnson Medical School and a member of Omnix’s Clinical Advisory Board. “The growing global spread of multidrug-resistant Gram-negative pathogens underscores the urgent need for novel anti-infective approaches with differentiated mechanisms of action.”

“What makes OMN6 particularly interesting is its differentiated membrane-disrupting mechanism of action, which is specifically designed to selectively target bacterial membranes and rapidly destroy them,” said Professor Yehuda Carmeli, MD, MPH, Head of the National Institute for Antibiotic Resistance and Infection Control, Tel Aviv Medical Center and a member of Omnix Clinical Advisory Board. “In severe Acinetobacter infections, where treatment options remain extremely limited and resistance development continues to increase globally, innovative antimicrobial peptides such as OMN6 with a differentiated mechanism of action may offer an important new therapeutic strategy.”

“Dosing the first patient in our Phase II study marks a major milestone for Omnix Medical and advances OMN6 further toward clinical proof-of-concept,” said Dr. Moshik Cohen-Kutner,Co-Founder & Chief Executive Officer of Omnix Medical. “OMN6 was engineered to selectively bind to bacterial membranes and rapidly destabilize them, leading to bacterial cell death while minimizing the potential for resistance development. We believe this novel mechanism could represent a promising new therapeutic approach for patients suffering from life-threatening multidrug-resistant Gram-negative infections with very limited available treatment options.”

OMN6 is a first-in-class, fast-acting antimicrobial peptide (AMP) with a novel mechanism of action designed to rapidly form pores in bacterial membranes, leading to a direct physical destruction of the pathogens. The compound targets multidrug-resistant Gram-negative pathogens, including carbapenem-resistant Acinetobacter baumannii (CRAB), and is derived from naturally occurring insect-derived antimicrobial peptides. OMN6 addresses severe infections with high unmet medical need and limited treatment options. Following successful Phase I development, the compound is currently being evaluated in an ongoing Phase II clinical study.

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Omnix Medical Secures $25 Million in Series C Funding Co-Led by Harel Insurance & Finance and the EIC Fund https://omnixmedical.com/2025/12/10/omnix-medical-secures/ https://omnixmedical.com/2025/12/10/omnix-medical-secures/#respond Wed, 10 Dec 2025 13:45:45 +0000 https://omnixmedical.com/?p=2635 — Existing and new investors joining forces to support the accelerated development of Omnix´s novel, first-in-class antimicrobials pipeline — Funding underlines urgent global need for novel, resistance-proof antimicrobials JERUSALEM, Israel, October 15, 2025 — Omnix Medical, a biopharmaceutical company developing next-generation anti-infectives for the treatment of life-threatening infections, announced today that it raised $25 million […]

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— Existing and new investors joining forces to support the accelerated development of Omnix´s novel, first-in-class antimicrobials pipeline

— Funding underlines urgent global need for novel, resistance-proof antimicrobials

JERUSALEM, Israel, October 15, 2025 — Omnix Medical, a biopharmaceutical company developing next-generation anti-infectives for the treatment of life-threatening infections, announced today that it raised $25 million in a Series C funding round co-led by Harel Insurance & Finance and the EIC Fund. Existing shareholders Entree Capital, Tal Ventures, Xenia Ventures, and Oriella Limited demonstrated strong confidence in Omnix’s approach by taking part in the round alongside new external investors, including Prevail Partners and OurCrowd.

This financing will enable Omnix to complete Phase II proof-of-concept studies for its lead compound, OMN6. The studies will focus on treating life-threatening infections caused by Gram-negative bacteria, particularly Acinetobacter baumannii, including strains resistant to last-line treatments such as carbapenems and colistin. The funding will also support regulatory activities, manufacturing scale-up, and the advancement of Omnix’s broader pipeline of engineered antimicrobial peptides. With this latest round of funding, Omnix has raised a total of $43 million since its inception in 2015.

Tomer Goldberg, Vice President, Managing Director Harel Technology Investments at Harel Insurance & Finance, said: “The rise of antibiotic-resistant infections is not just a medical crisis – it’s a societal one. At Harel, we are dedicated to supporting innovation and biotech, and we believe that companies like Omnix are essential to ensuring the development of effective treatments that protect lives and promote long-term wellbeing.”

“With the co-leadership of Harel Insurance & Finance and the EIC Fund, and the strong continued support of our existing shareholders, we now have the resources to complete Phase II proof-of-concept studies of OMN6, strengthen our regulatory and manufacturing capabilities, and advance our entire pipeline,” said Dr. Moshik Cohen-Kutner, Chief Executive Officer of Omnix Medical. “We are proud to have both the backing of new investors and the renewed trust of our long-standing shareholders. Together, they reflect the confidence in Omnix’s mission to deliver truly novel anti-infective solutions.”

OMN6 is a first-in-class antimicrobial peptide (AMP) with a novel mechanism of action (MoA) based on destroying bacterial cell membranes. It is therefore not only fast acting and bactericidal, but also effective regardless of bacterial genotype or resistance phenotype. OMN6 has so far shown excellent preclinical and clinical results regarding its efficacy, potency, and safety, but also high stability while maintaining bioactivity. The U.S. FDA has granted the compound Fast-Track and QIDP (Qualified Infectious Disease Product) designation.

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STUDY: In Vitro Antimicrobial Activity of OMN51 Against MDR Pseudomonas aeruginosa Isolated from People with Cystic Fibrosis https://omnixmedical.com/2025/09/11/study-in-vitro-antimicrobial-activity-of-omn51-against-mdr-pseudomonas-aeruginosa-isolated-from-people-with-cystic-fibrosis/ https://omnixmedical.com/2025/09/11/study-in-vitro-antimicrobial-activity-of-omn51-against-mdr-pseudomonas-aeruginosa-isolated-from-people-with-cystic-fibrosis/#respond Thu, 11 Sep 2025 07:10:24 +0000 https://omnixmedical.com/?p=2526 Omnix Medical tested its novel antimicrobial peptide, OMN51, on clinical isolates of multi-drug-resistant Pseudomonas aeruginosa collected from cystic fibrosis patients, in collaboration with Beilinson – Rabin Medical Center. The results demonstrated rapid bactericidal activity with complete clearance within 1-8 hours and minimal cytotoxicity to human cells.  OMN51 represents a first-in-class, membrane-targeting therapeutic showing promise against MDR P. aeruginosa.   […]

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Omnix Medical tested its novel antimicrobial peptide, OMN51, on clinical isolates of multi-drug-resistant Pseudomonas aeruginosa collected from cystic fibrosis patients, in collaboration with Beilinson – Rabin Medical Center.
The results demonstrated rapid bactericidal activity with complete clearance within 1-8 hours and minimal cytotoxicity to human cells. 
OMN51 represents a first-in-class, membrane-targeting therapeutic showing promise against MDR P. aeruginosa.
 
 

Authors: Moshe Heching, Moshe Cohen-Kutner, Haim Ben-Zvi, Liora Slomianksy, Elital Chass Maurice, Noa Nur Maymon, Shira Mandel, Michal Oholy, Rony Moses, Michal Lavon, Katherine Kaufman, Orel Mayost Lev-Ari,Tamar Shachar, Joel Weinberg, Mordechai R. Kramer and Niv Bachnoff.

 

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Antibacterial agents active against Gram Negative Bacilli in phase I, II, or III clinical trials https://omnixmedical.com/2025/05/15/antibacterial-agents-active-against-gram-negative-bacilli-in-phase-i-ii-or-iii-clinical-trials/ https://omnixmedical.com/2025/05/15/antibacterial-agents-active-against-gram-negative-bacilli-in-phase-i-ii-or-iii-clinical-trials/#respond Thu, 15 May 2025 22:58:20 +0000 https://omnixmedical.com/?p=2476 “Antibacterial agents active against Gram‑Negative Bacilli in Phase I, II, or III Clinical Trials,” by David L. Paterson, surveys nearly 50 investigational therapeutics—28 small‑molecule antibiotics and 21 non‑traditional modalities—now in the clinic. The review highlights both the promise of this pipeline and the obstacles that remain, including toxicity‑related attrition, funding gaps for pivotal Phase III studies in high‑mortality indications such as ventilator‑associated pneumonia, and the developmental […]

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“Antibacterial agents active against Gram‑Negative Bacilli in Phase I, II, or III Clinical Trials,” by David L. Paterson, surveys nearly 50 investigational therapeutics—28 small‑molecule antibiotics and 21 non‑traditional modalities—now in the clinic. The review highlights both the promise of this pipeline and the obstacles that remain, including toxicity‑related attrition, funding gaps for pivotal Phase III studies in high‑mortality indications such as ventilator‑associated pneumonia, and the developmental complexities faced by non‑traditional agents. 

Among the peptides profiled is OMN6, Omnix Medical’s novel 40‑amino‑acid cyclic derivative of cecropin A, which has shown potent activity against Acinetobacter baumannii, a favorable safety profile in 80 healthy volunteers, and is now advancing to a Phase IIa trial (NCT06087536) in hospital‑ and ventilator‑associated pneumonia. 

The article also underscores the need for concrete plans to ensure global access to new agents in regions where resistance to Gram‑negative bacilli is most prevalent.

David L. Paterson (2024) Antibacterial agents active against Gram Negative Bacilli in phase I, II, or III clinical trials, Expert Opinion on Investigational Drugs, 33:4, 371-387, DOI: 10.1080/13543784.2024.2326028 

Link to this article: https://doi.org/10.1080/13543784.2024.2326028


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REVIEW: Acinetobacter baumannii Complex Infections: New Treatment Options in the Antibiotic Pipeline https://omnixmedical.com/2025/02/07/review-acinetobacter-baumannii-complex-infections-new-treatment-options-in-the-antibiotic-pipeline/ Fri, 07 Feb 2025 16:46:14 +0000 https://omnixmedical.com/?p=2394 Acinetobacter baumannii complex (ABC) causes severe infections such as pneumonia and septic shock, yet therapeutic options—particularly for carbapenem‑resistant strains (CRAB)—remain scarce amid rising antimicrobial resistance. This review synthesizes the in‑vitro activity, mechanisms of action and clinical evidence behind the newly approved agents cefiderocol and sulbactam‑durlobactam, and profiles four late‑stage investigational candidates—BV‑100, cefepime‑zidebactam, zosurabalpin and OMN6—that may […]

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Acinetobacter baumannii complex (ABC) causes severe infections such as pneumonia and septic shock, yet therapeutic options—particularly for carbapenem‑resistant strains (CRAB)—remain scarce amid rising antimicrobial resistance. This review synthesizes the in‑vitro activity, mechanisms of action and clinical evidence behind the newly approved agents cefiderocol and sulbactam‑durlobactam, and profiles four late‑stage investigational candidates—BV‑100, cefepime‑zidebactam, zosurabalpin and OMN6—that may soon expand the treatment arsenal. 

READ REVIEW PUBLISHED 7 February 2025.

Authors: Noayna Arshad, Wael Azzam, Marya D. Zilberberg and Andrew F. Shorr

 

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Outstanding Scientific Research Award for Omnix Medical’s novel OMN51 https://omnixmedical.com/2025/01/01/outstanding-scientific-research-award-for-omnixs-novel-omn51/ https://omnixmedical.com/2025/01/01/outstanding-scientific-research-award-for-omnixs-novel-omn51/#respond Wed, 01 Jan 2025 23:44:53 +0000 https://omnixmedical.com/?p=2503 We’re thrilled to share that Omnix Medical’s research, in collaboration with Dr. Heching, the Adult Cystic Fibrosis and Bronchiectasis Clinic Director at Beilinson-Rabin Medical Center, has been awarded the prestigious award for Outstanding Scientific Research at the 2024 North American Israeli Pulmonary Alliance (NAIPAC) Conference in Jerusalem. The work, which summarizes a one-year study evaluating […]

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We’re thrilled to share that Omnix Medical’s research, in collaboration with Dr. Heching, the Adult Cystic Fibrosis and Bronchiectasis Clinic Director at Beilinson-Rabin Medical Center, has been awarded the prestigious award for Outstanding Scientific Research at the 2024 North American Israeli Pulmonary Alliance (NAIPAC) Conference in Jerusalem.

The work, which summarizes a one-year study evaluating the in vitro antimicrobial activity of Omnix Medical’s novel antimicrobial peptide, OMN51, against Pseudomonas aeruginosa clinical isolates demonstrated potent and consistent efficacy across both sensitive, resistant and multidrug resistant strains, highlighting OMN51’s potential as a powerful new therapeutic candidate.

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A Phase I First-in-Human Study To Evaluate the Safety and Pharmacokinetic (PK) Properties of the Intravenously (IV) Administered OMN6 https://omnixmedical.com/2024/11/15/a-phase-i-first-in-human-study-to-evaluate-the-safety-and-pharmacokinetic-pk-properties-of-the-intravenously-iv-administered-omn6/ https://omnixmedical.com/2024/11/15/a-phase-i-first-in-human-study-to-evaluate-the-safety-and-pharmacokinetic-pk-properties-of-the-intravenously-iv-administered-omn6/#respond Fri, 15 Nov 2024 17:39:21 +0000 https://omnixmedical.com/?p=2312 A Phase I First-in-Human Study To Evaluate the Safety and Pharmacokinetic (PK) Properties of the Intravenously (IV) Administered OMN6, a Novel Antimicrobial Peptide Targeting Acinetobacter Baumannii (A. Baumannii), In Adults Including Older Healthy Volunteers (HVS) Subjects Access Full Poster  Background Acinetobacter baumannii (AB) is an opportunistic Gram-negative pathogen ranked 1st on the World Health Organization […]

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A Phase I First-in-Human Study To Evaluate the Safety and Pharmacokinetic (PK) Properties of the Intravenously (IV) Administered OMN6, a Novel Antimicrobial Peptide Targeting Acinetobacter Baumannii (A. Baumannii), In Adults Including Older Healthy Volunteers (HVS) Subjects

 

Background

Acinetobacter baumannii (AB) is an opportunistic Gram-negative pathogen ranked 1st on the World Health Organization (WHO) Priority Pathogen list, that causes severe infections among elderly patients in intensive care units. Given the accelerating pace of global population aging, the burden of diseases including multi-drug resistant AB (MDRAB) infections is increasingly falling on elderly adults. Due to both elevated mortality rates associated with AB and the lack of effective treatments in older adults, there is a critical unmet need to develop new effective and safe anti-infectives. OMN6 is a novel, biochemically-engineered antimicrobial peptide, with a unique mechanism of action, which is being developed for the treatment of severe AB infections including carbapenem-resistant AB and MDRAB.

Methods

The First in Human Phase 1 OMN6 clinical trial was a single center, double-blind, placebo-controlled, randomized, single ascending total daily dose study, conducted in healthy volunteers. 5 single ascending total daily doses were tested; 5 cohorts in adults aged 18-59 years, and 1 cohort of older adults aged ≥ 60 years. Adults aged 18-59 years received doses ranging from 7.5 to 100 mg OMN6 as a 3-hour single IV infusion, while 50 mg was administered to both age groups (N=8/cohort). Safety and tolerability assessments, and pharmacokinetic (PK) blood sampling occurred at pre-defined timepoints. All blood samples for PK evaluation were analyzed with a validated LC/MS/MS assay. PK parameters of 50 mg OMN6 in both age groups were compared.

Results

No serious adverse events (SAEs) were reported in either adults or older adults and all dose levels were considered safe and well tolerated.

Upon a single infusion administration, mean PK results demonstrated dose-proportionality for Cmax and near dose-proportionality for AUCinf. The OMN6 PK profiles in adults and older adults at the 50 mg dose indicated a similar pattern. The mean AUCinf and Cmax for adults and older adults, were 1289 and 1211 h*ng/mL; and 502 and 470 ng/mL, respectively.

Conclusion

OMN6 had a favorable safety, tolerability, and PK profile that was similar in adults across all age groups. These positive results support advancing OMN6 to Phase 2 clinical trials, including subjects aged ≥ 60 years.

References

  1. Omnix Medical Ltd., Jerusalem, Israel
  2. QPS Netherlands, Groningen, The Netherlands
  3. Pulmonary and Critical Care Medicine, Medstar Washington Hospital Center, Washington DC, USA
 

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In Vitro Antimicrobial Activity of Novel Antimicrobial Peptide OMN51 Against Multi-drug Resistant Pseudomonas https://omnixmedical.com/2024/10/01/in-vitro-antimicrobial-activity-of-novel-antimicrobial-peptide-omn51-against-multi-drug-resistant-pseudomonas/ Tue, 01 Oct 2024 23:20:50 +0000 https://omnixmedical.com/?p=2487 Collaboration with Beilinson – Rabin Medical Center’s Cystic Fibrosis Clinic Omnix Medical has successfully completed a year-long collaboration with the Adult CF and Bronchiectasis Clinic, led by Dr. Moshe Heching at Beilinson-Rabin Medical Center. Results were presented recently in a poster during the last North American Cystic fibrosis conference (NACFC). The collaboration showcased the effectiveness of […]

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Collaboration with Beilinson – Rabin Medical Center’s Cystic Fibrosis Clinic

Omnix Medical has successfully completed a year-long collaboration with the Adult CF and Bronchiectasis Clinic, led by Dr. Moshe Heching at Beilinson-Rabin Medical Center. Results were presented recently in a poster during the last North American Cystic fibrosis conference (NACFC).

The collaboration showcased the effectiveness of Omnix’s innovative antimicrobial peptide, OMN51, in combating antibiotic-resistant bacteria in CF patients. The study evaluated the in vitro activity of OMN51 against dozens Pseudomonas aeruginosa strains isolated from people with CF. OMN51 demonstrated potent bactericidal activity across susceptible, resistant, and MDR strains with no observed resistance or cross-resistance. These findings support OMN-51’s potential as a promising therapeutic candidate.

View Poster: In Vitro Activity of Novel Peptide OMN51 on Multidrug Resistant Pseudomonas

Authors: Moshe Heching, Haim Ben Zvi, Rivka Glick, Liora Slomiansky, Joel Weinberg, Michal Oholy, Rony Moses, Noa Nur Maymon, Elital Chass Maurice, Shira Mandel, Moshik Cohen-Kutner, Niv Bachnoff, Mordechai R Kramer

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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

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 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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