OMN6 for Hospital-acquired bacterial pneumonia | Ventilator-associated bacterial pneumonia | Acinetobacter baumannii infection

Inclusion criteria

• {"criterion_text":"- 1. A signed informed consent form (ICF)."}
• {"criterion_text":"- 10. Background Antibiotic Therapy (BAT) including one or more of the following active BAT drugs: Meropenem, Ampicillin/Sulbactam and/or Colistin, is considered adequate empiric treatment for HABP/VABP based on local epidemiology."}
• {"criterion_text":"- 2. Male or female participants 18 years or older at the time of signing informed consent."}
• {"criterion_text":"- 3. Meeting the following clinical diagnosis criteria for HABP or VABP (refer to the protocol)"}
• {"criterion_text":"- 4. Participants with pneumonia Suspected or Confirmed to be associated with ABC Infection of the lungs (refer to the protocol)"}
• {"criterion_text":"- 5. Estimated glomerular filtration rate (eGFR) calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation: a. Sub-Cohort A (first sub-cohort at each dose level): eGFR >50 ml/min b. Sub-Cohort B (second sub-cohort at each dose level): eGFR 30–50 ml/min"}
• {"criterion_text":"- 6. Women of childbearing potential (WOCBP) (i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy) must have a negative serum pregnancy test within 72 hours prior to randomization."}
• {"criterion_text":"- 7. Participating WOCBP must be willing to consistently use at least one highly effective method of contraception from Screening until EOS. Male participants, with female partners of childbearing potential, must be willing to use barrier methods of contraception and to refrain from donating sperm until EOS."}
• {"criterion_text":"- 8. Acute Physiology and Chronic Health Evaluation II (APACHE II) score between 10 and 24 inclusive, or a Sequential Organ Failure Assessment (SOFA) score between 5 and 10 inclusive, at the time of diagnosis of infection. Participants not treated in an intensive care unit may be enrolled if they have a quick SOFA (qSOFA) score ≥ 2."}
• {"criterion_text":"- 9. A chest X-ray or computed tomography (CT) assessed during Screening, or a previous chest radiograph or CT obtained within 96 hours prior to randomization showing the presence of new or progressive infiltrate(s) suggestive of bacterial pneumonia."}

Exclusion criteria

• {"criterion_text":"- 1. Liver dysfunction - defined as the presence of one or more of the following laboratory abnormalities in baseline specimens: aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase, total bilirubin level >3 times the upper limit of normal (ULN), and/or platelet count <40,000/μL."}
• {"criterion_text":"- 10. Immunosuppression resulting from the presence of an immunocompromising condition or receipt of treatment with immunosuppressant medication. Conditions and medications include: hematologic malignancy on active chemotherapy or biologics or treated by CAR-T cell therapy, bone marrow/stem cell transplant, receiving medication for rejection of transplantation and long-term use of systemic corticosteroids (systemic equivalent to ≥ 20 mg/day prednisone for ≥ 2 weeks)."}
• {"criterion_text":"- 11. Any condition or circumstance that, in the opinion of the Investigator, would compromise the participant’s safety or the quality of the study data."}
• {"criterion_text":"- 12. Received another investigational drug or device within 30 days prior to study enrollment."}
• {"criterion_text":"- 13. Known or confirmed active co-infection caused by other Gram-negative bacteria resistant to all BAT options is excluded."}
• {"criterion_text":"- 14. The need for any additional or adjunctive non-study-specific antibiotic therapy (other than BAT) intended for the treatment of HABP or VABP."}
• {"criterion_text":"- 15. The need for any additional non-study specific therapy with drugs known to have significant interactions with BAT that could present a safety concern (e.g. valproic acid in participants receiving meropenem)."}
• {"criterion_text":"- 16. Concurrent infections in another site of the body that require either systemic, IV, or oral antibiotic therapy with activity against aerobic Gram-negative pathogens other than BAT."}
• {"criterion_text":"- 17. Expected survival < 48 hours."}
• {"criterion_text":"- 18. Breastfeeding and/or pregnant women (Pregnancy is defined as the state after conception until the termination of gestation)."}
• {"criterion_text":"- 2. Septic shock, defined as sepsis with persistent hypotension requiring vasopressor therapy to maintain a mean arterial pressure (MAP) > 65 mmHg, and a serum lactate level > 2 mmol/L (18 mg/dL) despite adequate volume resuscitation at time of randomization."}
• {"criterion_text":"- 3. Participants are excluded if they have received treatment with any BAT drug for more than 24 consecutive hours during the period from 14 days to 72 hours prior to the start of study treatment (Day 1). A single course lasting ≤24 hours during this period is permitted and does not result in exclusion. Participants are permitted to receive BAT drugs within 72 hours prior to the start of study treatment (Day 1)."}
• {"criterion_text":"- 4. History of any known hypersensitivity to Ampicillin/Sulbactam or Colistin or to carbapenems, or severe hypersensitivity to any other type of β-lactams other than cephalosporins and carbapenems (unless patient has previously received ampicillin-sulbactam or carbapenems without a significant adverse event)."}
• {"criterion_text":"- 5. Known or suspected community-acquired bacterial pneumonia, atypical pneumonia, viral pneumonia, or chemical pneumonia (including aspiration of gastric contents, inhalation injury)."}
• {"criterion_text":"- 6. Coinfection caused by invasive aspergillosis, mucormycosis, or other life-threatening mold infection."}
• {"criterion_text":"- 7. Central nervous system infection (e.g., meningitis, brain abscess, shunt infection)."}
• {"criterion_text":"- 8. Pulmonary disease precluding evaluation of a therapeutic response (such as lung cancer resulting in bronchial obstruction, active tuberculosis, cystic fibrosis, granulomatous disease, fungal pulmonary infection, lung abscess, pleural empyema, or post-obstructive pneumonia)."}
• {"criterion_text":"- 9. Neutropenia (i.e., polymorphonuclear neutrophils < 500 cells/μL)."}

Primary endpoints

• {"endpoint_text":"- Incidence of TEAE and SAEs by frequency, severity, relatedness, and outcome, clinical laboratory findings, vital signs and ECGs change from baseline and 28-day ACM.","definition_or_measurement_approach":"Incidence measured by count/frequency and categorisation by severity, relatedness and outcome; clinical laboratory results, vital signs and ECG changes will be evaluated as change from baseline; 28-day all-cause mortality assessed at Day 28."}
• {"endpoint_text":"- OMN6 PK parameters.","definition_or_measurement_approach":"Pharmacokinetic parameters of OMN6 (standard PK sampling and parameter derivation such as Cmax, AUC, t1/2) assessed per protocol."}

Secondary endpoints

• {"endpoint_text":"- Proportion of participants with clinical cure, clinical improvement, combined clinical cure plus clinical improvement.","definition_or_measurement_approach":"Proportion (percentage) of participants meeting prespecified clinical outcome criteria (clinical cure and/or clinical improvement) assessed per protocol-defined clinical criteria and timepoints."}

Methods

• Country-specific recruitment arrangements documents available (K1_Recruitment arrangements) — country files present for Greece, Hungary, Italy.
• Participant Identification Card materials (K2 recruitment material) for Greece, Hungary, Italy.
• Family Doctor Letter recruitment materials (K2 family doctor letter) — intended to engage primary care/family physicians to refer eligible hospitalised patients.

Greece

Earliest CTIS Part Ii Submission Date

25-01-2026

Latest Decision Or Authorization Date

07-05-2026

Processing Time Days

102

Number Of Sites

10

Number Of Participants

18

Hungary

Earliest CTIS Part Ii Submission Date

11-03-2026

Latest Decision Or Authorization Date

11-05-2026

Processing Time Days

61

Number Of Sites

2

Number Of Participants

8

Italy

Earliest CTIS Part Ii Submission Date

22-04-2026

Latest Decision Or Authorization Date

06-05-2026

Processing Time Days

14

Number Of Sites

1

Number Of Participants

6

Primary sponsor

Full Name

Omnix Medical Ltd.

Organisation Type

Pharmaceutical company

Country Of Registered Address

Israel

Third parties

• {"country":"United States","full_name":"Labconnect LLC","duties_or_roles":[{"id":1014033,"code":"4"}],"organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"Italy","full_name":"Aptuit (Verona) S.r.l.","duties_or_roles":[{"id":1014035,"code":"4"}],"organisation_type":"Pharmaceutical company"}
• {"country":"Estonia","full_name":"EU Micron OÜ","duties_or_roles":[{"id":1014027,"code":"1"},{"id":1014028,"code":"11"},{"id":1014029,"code":"12"},{"id":1014030,"code":"2"},{"id":1014031,"code":"5"},{"id":1014032,"code":"8"}],"organisation_type":"Pharmaceutical company"}
• {"country":"France","full_name":"Novasco","duties_or_roles":[{"id":1014025,"code":"15","value":"Service provider to facilitate payment of participant travel expenses"}],"organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Element Materials Technology Iowa City Inc.","duties_or_roles":[{"id":1014026,"code":"4"}],"organisation_type":"Industry"}
• {"country":"United States","full_name":"Prevail Infoworks","duties_or_roles":[{"id":1014020,"code":"3"},{"id":1014021,"code":"5"},{"id":1014022,"code":"6"},{"id":1014023,"code":"7"},{"id":1014024,"code":"8"}],"organisation_type":"Industry"}
• {"country":"Germany","full_name":"SGS Analytics Germany GmbH","duties_or_roles":[{"id":1014038,"code":"4"}],"organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"Germany","full_name":"BAG Health Care GmbH","duties_or_roles":[{"id":1014034,"code":"14"}],"organisation_type":"Pharmaceutical company"}
• {"country":"Greece","full_name":"The Hellenic Institute for the Study of Sepsis (HISS)","duties_or_roles":[{"id":1014036,"code":"1"},{"id":1014037,"code":"15","value":"co-ordination activities amongst Greek sites that are part of HISS."}],"organisation_type":"Educational Institution"}