The post Omnix Medical Secures $25 Million in Series C Funding Co-Led by Harel Insurance & Finance and the EIC Fund appeared first on Omnix Medical.
]]>— 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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]]>The post STUDY: In Vitro Antimicrobial Activity of OMN51 Against MDR Pseudomonas aeruginosa Isolated from People with Cystic Fibrosis appeared first on Omnix Medical.
]]>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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]]>The post Antibacterial agents active against Gram Negative Bacilli in phase I, II, or III clinical trials appeared first on Omnix Medical.
]]>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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]]>The post REVIEW: Acinetobacter baumannii Complex Infections: New Treatment Options in the Antibiotic Pipeline appeared first on Omnix Medical.
]]>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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]]>The post Outstanding Scientific Research Award for Omnix Medical’s novel OMN51 appeared first on Omnix Medical.
]]>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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]]>The post A Phase I First-in-Human Study To Evaluate the Safety and Pharmacokinetic (PK) Properties of the Intravenously (IV) Administered OMN6 appeared first on Omnix Medical.
]]>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
- Omnix Medical Ltd., Jerusalem, Israel
- QPS Netherlands, Groningen, The Netherlands
- Pulmonary and Critical Care Medicine, Medstar Washington Hospital Center, Washington DC, USA
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]]>The post In Vitro Antimicrobial Activity of Novel Antimicrobial Peptide OMN51 Against Multi-drug Resistant Pseudomonas appeared first on Omnix Medical.
]]>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
The post In Vitro Antimicrobial Activity of Novel Antimicrobial Peptide OMN51 Against Multi-drug Resistant Pseudomonas appeared first on Omnix Medical.
]]>The post Safety and Pharmacokinetic Results from the First-in-Human Study with Intravenously Administered OMN6 (A Poster) appeared first on Omnix Medical.
]]>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
- Centers for Disease Control and Prevention (2019). Antibiotic resistance threats in the US.
- Tacconelli E et al., Lancet Infect Dis. (2018), 18(3):318-327.
- Mandel S, et al. Sci Rep. (2021), 11(1):6603.
- Michaeli J, et al. Antibiotics (2022);11(9):1201.
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]]>The post Omnix Medical Granted Fast-Track Designation by U.S. FDA for its Next-Generation Anti-Infective OMN6 appeared first on Omnix Medical.
]]>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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]]>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.
]]>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
[email protected]
Media Inquiries
akampion
Dr. Ludger Wess / Ines-Regina Buth
Managing Partners
[email protected]
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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