A study that will check the safety, tolerability and effectiveness of the study drug (OMN6), as well as how the body responds to it after a single day of treatment, compared to patients who received a matching placebo.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Omnix Medical Ltd.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Respiratory Tract Diseases [C08]

Decision date (initial)

2026-05-07

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Omnix Medical Ltd.

External identifiers

EU CT number

2025-524200-29-00

WHO UTN

U1111-1331-9149

ClinicalTrials.gov

NCT06087536

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Pharmacokinetic

To evaluate the safety and tolerability and PK profile of single day dose-escalating OMN6 vs placebo in participants with HABP or VABP associated with ABC.

Secondary objectives 1

1. To evaluate the clinical outcomes following a single day of treatment with OMN6 vs. matching placebo.

Conditions and MedDRA coding

Hospital-acquired bacterial pneumonia or ventilated-associated bacterial pneumonia caused by Acinetobacter baumannii complex.

Study design 1 period

Regulatory references

Plan to share IPD

No

IPD plan description

A description of this research study will be available on a publicly accessible website: https://clinicaltrials.gov or https://euclinicaltrials.eu/search-for-clinical-trials. Patients/LARs are advised in the PIS-ICF that they can search the websites at any time. Patients/LARs are advised in the PIS-ICF that the websites will include a summary of the results within 1 year after the end of the trial. Websites or publications will not include information that can identify them.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 10

1. 1. A signed informed consent form (ICF).
2. 2. Male or female participants 18 years or older at the time of signing informed consent.
3. 3. Meeting the following clinical diagnosis criteria for HABP or VABP (refer to the protocol)
4. 4. Participants with pneumonia Suspected or Confirmed to be associated with ABC Infection of the lungs (refer to the protocol)
5. 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
6. 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.
7. 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.
8. 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.
9. 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.
10. 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.

Exclusion criteria 18

1. 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.
2. 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.
3. 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).
4. 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).
5. 5. Known or suspected community-acquired bacterial pneumonia, atypical pneumonia, viral pneumonia, or chemical pneumonia (including aspiration of gastric contents, inhalation injury).
6. 6. Coinfection caused by invasive aspergillosis, mucormycosis, or other life-threatening mold infection.
7. 7. Central nervous system infection (e.g., meningitis, brain abscess, shunt infection).
8. 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).
9. 9. Neutropenia (i.e., polymorphonuclear neutrophils < 500 cells/μL).
10. 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).
11. 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.
12. 12. Received another investigational drug or device within 30 days prior to study enrollment.
13. 13. Known or confirmed active co-infection caused by other Gram-negative bacteria resistant to all BAT options is excluded.
14. 14. The need for any additional or adjunctive non-study-specific antibiotic therapy (other than BAT) intended for the treatment of HABP or VABP.
15. 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).
16. 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.
17. 17. Expected survival < 48 hours.
18. 18. Breastfeeding and/or pregnant women (Pregnancy is defined as the state after conception until the termination of gestation).

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. 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.
2. OMN6 PK parameters.

Secondary endpoints 1

1. Proportion of participants with clinical cure, clinical improvement, combined clinical cure plus clinical improvement.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Omnix Medical Ltd.

Sponsor organisation

Omnix Medical Ltd.

Address

High Tech Village, Givat Ram Campus Givat Ram Campus

City

Jerusalem

Postcode

9270401

Country

Israel

Scientific contact point

Organisation

Omnix Medical Ltd.

Contact name

Chief Scientific Officer

Public contact point

Organisation

Omnix Medical Ltd.

Contact name

Chief Scientific Officer

Third parties 9

Locations

3 EU/EEA countries · 13 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 29 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications