Research Project
10084962
ABSTRACT Omnix Medical is developing novel antimicrobial peptides by applying their proprietary stabilization technology to Cecropins, a unique family of antimicrobial peptides (AMPs) from the innate immune systems of insects, which exert a potent effect on the bacterial membrane, compromising its integrity, causing cell lysis and rapid bacterial death. Multi-Drug Resistant (MDR) bacteria such as Acinetobacter baumannii (AB), especially Carbapenem- resistant AB (CRAB), present an increasing healthcare challenge. AB is designated number one on the WHO/CDC Pathogen-Priority list. Following a robust candidate selection process, the peptide OMN6 has presented the best antimicrobial activity against AB. OMN6 has progressed through preclinical studies, elucidating its mechanism of action, showing promising in vivo efficacy in a variety of infection models, and showing no adverse effects in in vivo toxicity studies. IND- enabling studies are being completed, in anticipation of an IND submission. OMN6 was designated a Qualified Infectious Disease Product (QIDP) by the FDA in 2017. Following a successful IND submission, Omnix is planning a Phase 1a clinical trial examining safety in healthy volunteers, utilizing a Single Ascending Dose (SAD), and a Phase 1b clinical trial examining safety and effectiveness of OMN6 administered with Imipenem vs Placebo with Imipenem in patients, utilizing a Multiple Ascending Dose (MAD) study design. The study outline currently anticipates a total number of 146 HV and patients recruited from a single site. This application seeks to bridge the gap between IND submission and initiation of FDA approved clinical trials. Omnix will contract with IQVIA? (formerly IMS Health & Quintiles), The Human Data Science Company?, as a Contract Research Organization in order to conduct the Phase I trial, and as such IQVIA will also be performing the trial start-up tasks outlined in this proposal. These include establishment of a project management structure and organization between Omnix and IQVIA; preparation of study material such as the clinical protocol and informed consent forms; identification and contact establishment with clinical sites; and support of regulatory activities, including FDA and IRB submissions.
