Periodic Reporting for period 1 - OMN6 (A novel class of antibiotics to combat Antimicrobial Resistance)
Periodo di rendicontazione: 2021-07-01 al 2022-08-31
Omnix Medical is a privately-owned biotechnology company developing the next-generation of antibiotics against Multi Drug Resistant (MDR) bacteria. Use and misuse of antibiotics has led to the evolution of antibiotic resistance. We are today facing an Antimicrobial Resistance (AMR) pandemic that translates into 1.27 million deaths annually and at the current rate, infections nonresponsive to existing treatments will become a more common cause of death than cancer and diabetes combined by 2050.
Omnix is addressing an urgent and imminent threat to public health by developing an arsenal of antimicrobial peptides (AMPs) as therapeutic agents for treatment of life-threatening infections. We offer therapies that are effective and safe and, in our pipeline, we have peptides able to effectively kill multi-drug resistant (MDR) bacterial strains featured as the most critical on WHO’s pathogen list.
The goal of the project is to establish a clinical proof of concept (PoC) of OMN6, our lead compound, through Phase I/II trials. Omnix Overall-Objective is to provide a safer, more efficient alternative to win the battle against Antimicrobial Resistance by offering therapies that are, by design, resilient against resistance development. The scope of the EIC grant project is to initiate and complete Phase I clinical trials with OMN6 and get an approval for Phase II clinical studies.
Omnix is addressing an urgent and imminent threat to public health by developing an arsenal of antimicrobial peptides (AMPs) as therapeutic agents for treatment of life-threatening infections. We offer therapies that are effective and safe and, in our pipeline, we have peptides able to effectively kill multi-drug resistant (MDR) bacterial strains featured as the most critical on WHO’s pathogen list.
The goal of the project is to establish a clinical proof of concept (PoC) of OMN6, our lead compound, through Phase I/II trials. Omnix Overall-Objective is to provide a safer, more efficient alternative to win the battle against Antimicrobial Resistance by offering therapies that are, by design, resilient against resistance development. The scope of the EIC grant project is to initiate and complete Phase I clinical trials with OMN6 and get an approval for Phase II clinical studies.
Since inception, Omnix has been working diligently to offer safer and resistance resilient treatment options for life-threatening infections. Comprehensive pre-clinical research was performed at the company’s facilities, as well as with top-tier CROs, encompassing all the in-vitro science, the in-vivo models for infectious diseases and all the safety, toxicology and PK/PD ADME studies that are required to initiate clinical trials in humans. The work that was done within the scope of this grant includes:
1. The writing, compiling and submission of all the regulatory-packages to the relevant competent authorities and receiving the approval for the initiation of Phase-1 clinical trials with OMN6.
2. The planning, designing, logistics and execution of the First-In-Human clinical Phase-1 trial in Groningen, The Netherlands: A First in Human, Phase 1, Randomized, Double-blind, Placebo-controlled, Single Ascending Total Daily Dose Study to Assess Safety, Tolerability, and Pharmacokinetics of Single and Multiple Intravenous Infusion of OMN6 in Healthy Subjects. The study evaluates total daily doses in male, female and elderly populations with the Primary Objective to determine the safety and tolerability of single and multiple ascending i.v. doses of OMN6 in healthy young and elderly adult subjects.
3. Preliminary planning and designing of the Phase-2 Clinical trials with OMN6
Results: So far 47 people have been dosed in 6 separate cohorts. No Severe or Serious Adverse Events were observed in all dose levels, with Dose proportional elevation in PK parameters. All current data from the clinical trial taken together with the pre-clinical data suggest that efficacy in humans is feasible with no toxicity and that Omnix Medicals’ AMPs are closer than ever to becoming the next generation of antibiotic drugs.
1. The writing, compiling and submission of all the regulatory-packages to the relevant competent authorities and receiving the approval for the initiation of Phase-1 clinical trials with OMN6.
2. The planning, designing, logistics and execution of the First-In-Human clinical Phase-1 trial in Groningen, The Netherlands: A First in Human, Phase 1, Randomized, Double-blind, Placebo-controlled, Single Ascending Total Daily Dose Study to Assess Safety, Tolerability, and Pharmacokinetics of Single and Multiple Intravenous Infusion of OMN6 in Healthy Subjects. The study evaluates total daily doses in male, female and elderly populations with the Primary Objective to determine the safety and tolerability of single and multiple ascending i.v. doses of OMN6 in healthy young and elderly adult subjects.
3. Preliminary planning and designing of the Phase-2 Clinical trials with OMN6
Results: So far 47 people have been dosed in 6 separate cohorts. No Severe or Serious Adverse Events were observed in all dose levels, with Dose proportional elevation in PK parameters. All current data from the clinical trial taken together with the pre-clinical data suggest that efficacy in humans is feasible with no toxicity and that Omnix Medicals’ AMPs are closer than ever to becoming the next generation of antibiotic drugs.
In-light of the recent COVID-19 pandemic, the potential impact on public health as well as the socio-economic impact and wider societal implications of Omnix Medical’s OMN6 project have become more important and more significant. The urgency to develop new treatments against resistant bacteria was emphasized by the COVID-19 pandemic that exposed the true state of the anti-infective therapeutic area as one with very limited solutions and with even less time to try and mitigate it than presumed. Referred to as the “Silent Pandemic” AMR is responsible for, roughly, half of the lethal secondary infections in COVID patients. It is vital today, even more than before, to continue and complete the development of new antibiotic agents.