A Phase 2a, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Pharmacokinetics of OMN6 in Patients with Acinetobacter baumannii Complex-Induced HABP or VABP

Trial ID: 2025-524200-29-00
Protocol: OMN6-002
Sponsor: Omnix Medical Ltd.

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Diseases & Conditions

Pneumonia bacterial

Objectives

The primary objective of this study is to evaluate the safety, tolerability, and pharmacokinetics of single-day dose-escalating OMN6 compared to a placebo in patients with hospital-acquired bacterial pneumonia or ventilator-associated bacterial pneumonia caused by Acinetobacter baumannii complex. The secondary objective involves the evaluation of clinical outcomes following a single day of treatment with OMN6 versus a matching placebo.

Participants

This clinical trial involves a total of 4 participants. The study population consists of male and female patients aged 18 years or older diagnosed with hospital-acquired bacterial pneumonia or ventilator-associated bacterial pneumonia caused by Acinetobacter baumannii complex. Eligible individuals must demonstrate new or progressive pulmonary infiltrates via chest X-ray or computed tomography. Clinical severity is assessed using an APACHE II score between 10 and 24, a SOFA score between 5 and 10, or a qSOFA score of 2 or greater. Participants are categorized into sub-cohorts based on an estimated glomerular filtration rate between 30 and >50 ml/min. Required background antibiotic therapy includes agents such as meropenem, ampicillin/sulbactam, or colistin. Women of childbearing potential must maintain a negative serum pregnancy test and utilize effective contraception.

Plans and Procedures

This is a prospective, multinational, multicenter, randomized, sequential, double-blind, placebo-controlled, phase 2a clinical study. The objective is to evaluate the safety, tolerability, and pharmacokinetics of a single-day dose-escalating administration of OMN6 compared to a saline placebo in subjects with hospital-acquired bacterial pneumonia or ventilator-associated bacterial pneumonia caused by Acinetobacter baumannii complex. The study design utilizes two sub-cohorts based on the estimated glomerular filtration rate to assess different renal function levels. Primary endpoints include the incidence of treatment-emergent adverse events, serious adverse events, clinical laboratory findings, vital signs, electrocardiogram changes, and 28-day all-cause mortality, alongside pharmacokinetic parameters. Secondary endpoints consist of the proportion of subjects achieving clinical cure or clinical improvement. The research period is estimated to occur between May 2026 and May 2028. The study sequence begins with a screening visit to assess inclusion criteria, such as age, clinical diagnosis via chest X-ray or computed tomography, and specific physiological scores like APACHE II or SOFA. Following successful screening, subjects undergo randomization and receive either intravenous infusion of the test product or placebo. The protocol involves a single day of treatment with subsequent monitoring to determine safety and efficacy profiles.

Treatment

The experimental medication consists of OMN6, provided as a powder for infusion. The study involves intravenous administration of a 450 mg dose. This phase 2a clinical trial utilizes a single day dose-escalating regimen to evaluate the safety and pharmacokinetics in patients with hospital-acquired bacterial pneumonia or ventilator-associated bacterial pneumonia caused by Acinetobacter baumannii complex.

The control group receives saline as a placebo. This substance is administered via intravenous infusion at a volume of 714.3 ml.

Efficacy

The assessment of efficacy in this study focuses on the clinical response in participants with hospital-acquired bacterial pneumonia or ventilator-associated bacterial pneumonia caused by Acinetobacter baumannii complex. Secondary endpoints include the proportion of participants achieving clinical cure, clinical improvement, or a combined measure of clinical cure plus clinical improvement.

Inclusion and Exclusion Criteria

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Inclusion Criteria

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

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Exclusion Criteria

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.
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.
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).
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).
Known or suspected community-acquired bacterial pneumonia, atypical pneumonia, viral pneumonia, or chemical pneumonia (including aspiration of gastric contents, inhalation injury).
Coinfection caused by invasive aspergillosis, mucormycosis, or other life-threatening mold infection.
Central nervous system infection (e.g., meningitis, brain abscess, shunt infection).
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).
Neutropenia (i.e., polymorphonuclear neutrophils < 500 cells/μL).
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).
Any condition or circumstance that, in the opinion of the Investigator, would compromise the participant’s safety or the quality of the study data.
Received another investigational drug or device within 30 days prior to study enrollment.
Known or confirmed active co-infection caused by other Gram-negative bacteria resistant to all BAT options is excluded.
The need for any additional or adjunctive non-study-specific antibiotic therapy (other than BAT) intended for the treatment of HABP or VABP.
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).
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.
Expected survival < 48 hours.
Breastfeeding and/or pregnant women (Pregnancy is defined as the state after conception until the termination of gestation).