Periodic Reporting for period 2 - OMN6 (A novel class of antibiotics to combat Antimicrobial Resistance)
Période du rapport: 2022-09-01 au 2023-10-31
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 Medical's dedication to combatting antibiotic resistance is crucial in addressing the alarming global threat of drug-resistant bacteria. The misuse and overuse of antibiotics have indeed accelerated the evolution of resistant strains, leading to a significant health crisis. The projected statistics highlighting the potential impact of antimicrobial resistance on mortality rates are deeply concerning.
The stagnant innovation in antibiotic development over the past few decades due to financial disincentives is a stark reality. Physicians often preserve newer antibiotics, impacting the profitability of creating new ones. Omnix's approach with novel technology that disrupts the cycle of resistance is promising. By developing pharmaceuticals that are effective against resistant bacteria and minimizing the likelihood of new resistance mechanisms, Omnix is pioneering a crucial breakthrough in this field.
This innovative strategy not only addresses the urgent need for new antibiotics but also has the potential to revolutionize the way we combat antibiotic resistance. It's a hopeful step toward saving lives and reducing the impact of resistant infections, potentially reshaping the future of healthcare.
The outlined objectives for the grant period encompass two primary goals:
1.Regulatory Package Submission and Phase-1 Trial Approval:
- Prepare, compile, and submit regulatory packages to relevant authorities for Phase-1 clinical trials with OMN6.
- Obtain approval to initiate Phase-1 clinical trials.
2. Execution of First-In-Human Phase-1 Trial in Groningen, The Netherlands:
- Conduct a First in Human, Phase 1, Randomized, Double-blind, Placebo-controlled, Single Ascending Total Daily Dose Study.
- Assess the safety, tolerability, and pharmacokinetics of single and multiple intravenous infusions of OMN6 in healthy subjects.
- Evaluate total daily doses in male, female, and elderly populations.
- Primary Objective: Determine the safety and tolerability of single and multiple ascending intravenous doses of OMN6 in healthy young and elderly adult subjects.
- Design, write, and gain approval for Phase-2 clinical trials to evaluate OMN6 in severely ill patients based on Phase-1 trial outcomes.
Overall, the objectives entail regulatory compliance, conducting comprehensive safety and tolerability assessments of OMN6 in healthy subjects, and laying the groundwork for subsequent Phase-2 trials in severely ill patients.
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 Medical's dedication to combatting antibiotic resistance is crucial in addressing the alarming global threat of drug-resistant bacteria. The misuse and overuse of antibiotics have indeed accelerated the evolution of resistant strains, leading to a significant health crisis. The projected statistics highlighting the potential impact of antimicrobial resistance on mortality rates are deeply concerning.
The stagnant innovation in antibiotic development over the past few decades due to financial disincentives is a stark reality. Physicians often preserve newer antibiotics, impacting the profitability of creating new ones. Omnix's approach with novel technology that disrupts the cycle of resistance is promising. By developing pharmaceuticals that are effective against resistant bacteria and minimizing the likelihood of new resistance mechanisms, Omnix is pioneering a crucial breakthrough in this field.
This innovative strategy not only addresses the urgent need for new antibiotics but also has the potential to revolutionize the way we combat antibiotic resistance. It's a hopeful step toward saving lives and reducing the impact of resistant infections, potentially reshaping the future of healthcare.
The outlined objectives for the grant period encompass two primary goals:
1.Regulatory Package Submission and Phase-1 Trial Approval:
- Prepare, compile, and submit regulatory packages to relevant authorities for Phase-1 clinical trials with OMN6.
- Obtain approval to initiate Phase-1 clinical trials.
2. Execution of First-In-Human Phase-1 Trial in Groningen, The Netherlands:
- Conduct a First in Human, Phase 1, Randomized, Double-blind, Placebo-controlled, Single Ascending Total Daily Dose Study.
- Assess the safety, tolerability, and pharmacokinetics of single and multiple intravenous infusions of OMN6 in healthy subjects.
- Evaluate total daily doses in male, female, and elderly populations.
- Primary Objective: Determine the safety and tolerability of single and multiple ascending intravenous doses of OMN6 in healthy young and elderly adult subjects.
- Design, write, and gain approval for Phase-2 clinical trials to evaluate OMN6 in severely ill patients based on Phase-1 trial outcomes.
Overall, the objectives entail regulatory compliance, conducting comprehensive safety and tolerability assessments of OMN6 in healthy subjects, and laying the groundwork for subsequent Phase-2 trials in severely ill patients.
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. Planning and designing of the Phase-2 Clinical trials with OMN6, Approval of Ph2 studies by competent authorities.
Results: 80 healthy subjects have been dosed in 10 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. Planning and designing of the Phase-2 Clinical trials with OMN6, Approval of Ph2 studies by competent authorities.
Results: 80 healthy subjects have been dosed in 10 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.