A Clinical Trial to Assess the Safety and PK of OMN6 in HABP or VABP Caused by Acinetobacter Baumannii Complex

A Prospective, Multinational, Multicenter, Randomized, Sequential, Double-blind, Placebo-controlled, Phase 2a Clinical Trial to Assess the Safety and Pharmacokinetics of OMN6 in HABP or VABP Caused by Acinetobacter Baumannii Complex (ABC).

This is a phase 2a, multinational, multicenter, double-blind, randomized, placebo-controlled, dose-ranging safety, tolerability and PK study in patients with HABP (Hospital Acquired Bacterial Pneumonia) or VABP (Ventilator Associated Bacterial Pneumonia) caused by ABC to identify safe and well-tolerated doses and to assess the PK profile of OMN6 in patients.

Study Overview

• Status: Recruiting
• Conditions: Ventilator-associated Bacterial Pneumonia; Hospital-acquired Bacterial Pneumonia
• Intervention / Treatment: Drug: OMN6; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 54
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Bella Shusterman; Phone Number: +972 2 5320871; Email: bella@omnixmedical.com

Study Locations

• Israel
  • Be’er Ya‘aqov, Israel
    • Recruiting
    • Omnix Medical Research Site
  • Holon, Israel
    • Recruiting
    • Omnix Medical Research Site
  • Petah Tikva, Israel
    • Recruiting
    • Omnix Medical Research Site
  • Ramat Gan, Israel
    • Recruiting
    • Omnix Medical Research Site
  • Rishon LeZiyyon, Israel
    • Recruiting
    • Omnix Medical Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. A signed informed consent form.
2. Male or female patients 18 years or older
3. A diagnosis of either a HABP or a VABP
4. ABC infection of the lower respiratory tract suspected based on a positive rapid testing of respiratory specimens
5. Women of childbearing potential (WOCBP) (i.e., not post-menopausal or surgically sterilized) must have a negative highly sensitive urine or serum pregnancy test before randomization.
6. Acute Physiology and Chronic Health Evaluation II (APACHE II) score between 10 and 24

Exclusion Criteria:

1. Moderate to severe reduction of renal function
2. Liver dysfunction
3. Evidence of septic shock
4. Acute respiratory distress syndrome.
5. Immunosuppressed patients (due to either immunosuppressant drugs or to any medical condition).
6. History of any known hypersensitivity to colistin or to carbapenems
7. Any condition or circumstance that, in the opinion of the investigator, would compromise the safety of the patient or the quality of the study data

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: OMN6 treatment; OMN6 on top of Meropenem and Colistin	Drug: OMN6; Cohort 1: 50 mg x 3/day Cohort 2: 100 mg x 3/day Cohort 3: 150 mg x 3/day 3 x 3-hour IV infusions for 1 Day of treatment concomitant with background antimicrobial treatment with meropenem plus colistin for 7 to 14 days
Placebo Comparator: Placebo; Placebo on top of Meropenem and Colistin	Drug: Placebo; 3 x 3-hour IV infusions for 1 Day of treatment concomitant with background antimicrobial treatment with meropenem plus colistin for 7 to 14 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To assess the safety of a single-day treatment with OMN6 vs. matching placebo when coadministered with a background therapy of meropenem and colistin	Incidence of TEAE and SAEs by frequency, severity, relatedness, and outcome, clinical laboratory findings change from baseline, vital signs and ECGs change from baseline.	28 day
To asses the Cmax of OMN6 in patient population	Maximum Observed Plasma Concentration	1 day
To assess the Tmax of OMN6 in patient population	Time to Cmax	1 day
To assess the AUC of OMN6 in patient population	Area Under the Plasma Concentration-Time Curve	1 day
To assess the t1/2 of OMN6 in patient population	Time to Half-life	1 day

Collaborators and Investigators

• Sponsor: Omnix Medical Ltd

Publications and helpful links

Helpful Links

• OMN6 a novel bioengineered peptide for the treatment of multidrug resistant Gram negative bacteria
• In Vitro and In Vivo Antimicrobial Activity of the Novel Peptide OMN6 against Multidrug-Resistant Acinetobacter baumannii

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: July 25, 2023
• First Submitted That Met QC Criteria: October 11, 2023
• First Posted (Actual): October 17, 2023

Study Record Updates

• Last Update Posted (Actual): March 11, 2026
• Last Update Submitted That Met QC Criteria: March 8, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: HABP VABP ABC Acinetobacter baumannii pneumonia
• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; Respiratory Tract Diseases; Lung Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Pneumonia; Pneumonia, Bacterial
• Other Study ID Numbers: OMN6-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No