You are currently viewing Congratulations to Omnix Medical, on Phase II Trial Of Your Next-Generation Anti-Infective OMN6 FDA Approval!
  • Phase I data show safety and tolerability at clinically significant dose levels
  • A new class of anti-infectives to treat infections with Gram-negative bacteria

The FDA just green lighted Omnix Medical ‘s planned Phase II trial for OMN6, a groundbreaking anti-infective aimed at treating severe bacterial pneumonia. This novel therapy, based on antimicrobial peptides, shows promise in effectively targeting Gram-negative bacteria, including drug-resistant strains. Omnix Medical is a Jerusalem-based biopharmaceutical company

The multinational, multicenter trial will assess the safety and pharmacokinetics of OMN6 in patients with hospital-acquired bacterial pneumonia (HABP) or ventilator-associated bacterial pneumonia (VABP) caused by Acinetobacter baumannii complex (ABC).

Acinetobacter baumannii are bacteria that cause infections in the blood, lungs, kidneys, brain, and other organs, that have developed mechanisms to evade the action of many types of antibiotics. These germs are frequent causes of hospital-acquired infections, especially in intensive care units (ICUs). The World Health Organization (WHO) has included Acinetobacter baumannii in the critical group of bacteria that are the greatest threat to human health. Without changes in policy, WHO  estimates that antimicrobial-resistant infections may result in 10 million annual deaths by 2050.  Further, the World Bank estimates that the global economy may lose up to 3.8% of its annual gross domestic product (GDP) by 2050, with an annual shortfall of up to $3.4 trillion by 2030.

Omnix Medical´s lead compound OMN6 is a novel, first-in-class antimicrobial peptide (AMP) based on insect host defense peptides. Its mechanism of action (MoA) is based on a totally novel principle compared to conventional anti-infectives – the compound destroys bacterial cell membranes, enabling a fast and effective onset of action regardless of bacterial genotype or resistance phenotype.

In a randomized, double-blind, placebo-controlled, single ascending dose Phase I study with over 80 healthy volunteers, OMN6 has demonstrated excellent safety and tolerability at clinically significant dose levels. Moreover, complete clearance of the drug could be shown, allowing for multiple daily infusions as is common with anti-infective treatments.

“We are very pleased that the U.S. FDA has approved our planned Phase II study,” said Dr. Moshik Cohen-Kutner, CEO of Omnix Medical. “As we have seen very encouraging results in our previous Phase I trial, we hope that the Phase II data will confirm these data. This would be a key milestone in the development of a novel class of anti-infectives that are not associated with a development of antimicrobial resistance.”

Dr. Niv Bachnoff, CSO of Omnix Medical, added: “We look forward to initiating this Phase II trial in the coming months. Our goal is to provide a potent alternative to conventional anti-infectives and to save the lives of millions of patients worldwide who no longer respond to currently available antibiotics.”

This summer, the Indian Patent Office issued a Notice of Allowance for Omnix Medical’s lead antimicrobial peptide for the treatment of infectious diseases. This Notice of Allowance follows the patent protection previously granted to OMN6 in several other major international markets, including the United States, European Union, China, Australia, and Japan. The repeated validation from patent offices worldwide testifies to the unique, innovative, and significant nature of Omnix Medical‘s work in fighting infectious diseases.

The antimicrobial peptides market is projected to grow at a CAGR of 5.80% during the forecast period of 2022-2029. The Antimicrobial Peptides Market value is expected USD 7.85 billion by 2029.

About Omnix Medical

Omnix Medical was founded in 2015 to address the urgent unmet need for new life-saving anti-infective drugs. Omnix´s 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´s technology, kills bacteria upon contact and has successfully evolved over 200 million years. The Omnix’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´s technology prevents the development of new resistances and is thus well positioned to become the first-line-treatment to win the war against AMR.

About OMN6

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. Omnix Medical, Omnix‘s lead compound, is intended for the treatment of life-threatening infections caused by Gram-negative bacteria such as Acinetobacter baumannii.

Corporate Contacts:
Moshik Cohen-Kutner, CEO +972-50-8698218

Niv Bachnoff, CSO +972-54-238-6023

For further information,  contact contact AT omnixmedical.com  or the website at Omnix Medical:   http://www.omnixmedical.com/

Twitter: https://twitter.com/MedicalOmnix or LinkedIn: http://linkedin.com/company/omnix-medical

 

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