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.
