OMN6 / Omnix Medical - LARVOL DELTA

Antibiotics and non-traditional antimicrobial agents for carbapenem-resistant Acinetobacter baumannii in Phase 1, 2, and 3 clinical trials. (PubMed, Expert Opin Investig Drugs) - "Specifically, 9 antibiotics are in Phase 1 (R-327, xeruborbactam/QPX-7728, upleganan/SPR-206, MRX-8, QPX-9003, zifanocycline/KBP-7072, apramycin/EBL-1003, zosurabalpin/RG-6006, and ANT-3310), two in Phase 2 (BV-100, OMN-6), and two in Phase 3 (zidebactam/WCK-5222, funobactam/XNW-4107) clinical trials...In particular, two monoclonal antibodies (TRL-1068, CMTX-101), a phage therapy (Phagebank), an immune-modulating agent (recombinant human plasma gelsolin/Rhu-pGSN), a microbiome-modulating agent (SER-155), and an engineered cationic antibiotic peptide (PLG-0206). Several agents with promising characteristics against CRAB infections are in clinical development (Phases 1, 2, and 3). The urgent need for therapeutic options against CRAB infections necessitates optimizing efforts and time for introducing successfully studied agents into clinical practice."

Journal • Review • Infectious Disease • GSN

Acinetobacter baumannii Complex Infections: New Treatment Options in the Antibiotic Pipeline. (PubMed, Microorganisms) - "Furthermore, many older agents, such as polymyxin and colistin, have limited lung penetration and are associated with significant toxicities. In order to place these newer molecules in context and to help clinicians appreciate the emerging potential drug development pipeline, we describe the in vitro activity, mechanisms of action, and clinical trial data not only for the commercially now available alternatives, such as cefiderocol and sulbactam-durlobactam, but also review these topics for molecules undergoing phase II and III clinical trials. Specifically, we discuss and analyze data related to four novel drugs from ABC: BV-100, cefepime-zidebactam, zosurabalpin, and OMN6."

Journal • Review • Infectious Disease • Pneumonia • Respiratory Diseases • Septic Shock

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 (AB), in Adults including Older Healthy Volunteers (HVs) Subjects (IDWeek 2024) - No abstract available

Clinical • P1 data • PK/PD data • Infectious Disease

A Clinical Trial to Assess the Safety and PK of OMN6 in HABP or VABP Caused by Acinetobacter Baumannii Complex (clinicaltrials.gov) - P2 | N=54 | Recruiting | Sponsor: Omnix Medical Ltd | Not yet recruiting ➔ Recruiting | Phase classification: P2a ➔ P2

Enrollment open • Phase classification • Infectious Disease • Pneumonia • Respiratory Diseases

Safety and pharmacokinetic results from the first-in-human study with intravenously administered OMN6, a novel antimicrobial peptide for Acinetobacter baumannii (AB), conducted in healthy volunteers (ECCMID 2024) - No abstract available

Clinical • P1 data • PK/PD data

A Clinical Trial to Assess the Safety and PK of OMN6 in HABP or VABP Caused by Acinetobacter Baumannii Complex (clinicaltrials.gov) - P2a | N=54 | Not yet recruiting | Sponsor: Omnix Medical Ltd

New P2a trial • Infectious Disease • Pneumonia • Respiratory Diseases