Omnix Medical Announces Excellent Topline Data from the Phase I Clinical Trial of its Novel Anti-Infective OMN6
– OMN6 demonstrates safety and tolerability at clinically significant dose levels
Omnix Medical, a biopharmaceutical company developing next-generation anti-infectives for the treatment of life-threatening infections, today announced positive top-line results from the Phase I clinical trial of its lead compound OMN6, an anti-infective with a completely novel mechanism of action. All endpoints were met: No severe or serious adverse events (SEs/SAEs) were observed at any dose level in the study while clinically meaningful levels of OMN6 were achieved in the blood and complete clearance of the drug was demonstrated, allowing for multiple daily infusions as is common with anti-infective treatments.
The study, conducted in Groningen, The Netherlands, covered a total of 80 healthy volunteers, including a cohort of elderly patients, and was designed as a randomized, double-blind, placebo-controlled, single ascending dose study. Primary endpoints were safety and tolerability of single ascending i.v. doses of OMN6. The secondary endpoint was to evaluate the pharmacokinetics (PK) of OMN6 in the plasma of healthy young and elderly adult volunteers.
OMN6 is a novel, first-in-class antimicrobial peptide (AMP) based on insect host defense peptides. Its mechanism of action (MoA) is based on disruption of bacterial cell membranes and is therefore effective regardless of bacterial genotype or resistance phenotype, and unlike conventional bacteriostatic antibiotics, it is fast acting and bactericidal. OMN6 has been optimized from the original AMP by Omnix Medical´s proprietary technology to exhibit not only remarkable efficacy, potency, and safety, but also high stability while maintaining bioactivity. As a result, Omnix Medical believes that its novel peptides can be considered a new class of antimicrobial drugs. OMN6, the Company’s lead compound, is intended for the treatment of life-threatening infections caused by Gram-negative bacteria such as Acinetobacter baumannii.
“We are very pleased with these results,” said Dr. Moshik Cohen-Kutner, CEO of Omnix Medical. “They demonstrate that our approach is safe and that the compound is well tolerated at clinically significant doses, even in the elderly. This is a very important milestone as the burden of antimicrobial resistance is estimated to be 4.95 million deaths per year worldwide.”
Dr. Niv Bachnoff, CSO of Omnix Medical, added: “This is a very important milestone on the way to establishing a new class of antibiotics that are orders of magnitude less likely to induce resistance, recrudescence or tolerance in bacterial pathogens. We are now looking forward to preparing a Phase II trial with OMN6 in the coming months.”
About Omnix Medical
Omnix Medical was founded in 2015 to address the urgent unmet need for new life-saving anti-infective drugs. Omnix´ proprietary technology eliminates bacteria by mimicking the innate immune system of insects which uses unique molecules to efficiently and selectively kill resistant bacterial strains without toxic effects. This mechanism, which is at the core of Omnix´ technology, kills bacteria upon contact and has successfully evolved over 200 million years. The Company’s lead compound is being developed for the treatment of life-threatening hospital-acquired infections (HIA) and has shown significantly higher potency than currently available treatments. Most importantly, Omnix´ technology prevents the development of new resistances and is thus well positioned to become the first-line-treatment to win the war against AMR.