Saturday, April 20, 2024

Omnix Medical’s OMN6 Receives FDA’s Fast-Track Designation for Revolutionary Anti-Infective

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Omnix Medical has achieved a significant milestone in its pursuit of innovative treatments for life-threatening infections, with the U.S. Food and Drug Administration (FDA) granting fast-track designation to its groundbreaking anti-infective, OMN6. This fast-track designation highlights the pressing need for new antimicrobial solutions capable of combating infections caused by Gram-negative bacteria.

Based in Jerusalem, Israel, Omnix Medical is at the forefront of developing next-generation anti-infectives aimed at addressing the critical challenge of life-threatening bacterial infections. The fast-track designation awarded to OMN6 by the FDA underscores the potential of this novel antimicrobial peptide (AMP) to meet an unmet medical need by providing a serious or life-threatening condition with a new treatment option.

OMN6 distinguishes itself as a novel, first-in-class AMP derived from insect host defense peptides. Its unique mechanism of action sets it apart from traditional anti-infectives; it physically disrupts bacterial cell membranes, leading to rapid and effective bacterial eradication that is independent of the bacteria’s genotype or resistance phenotype. This innovative approach offers hope for swift and efficient treatment of bacterial infections without contributing to the growing problem of antimicrobial resistance.

Omnix Medical Targets Superbug Pneumonias with Novel Treatment

Following the FDA’s authorization of an Investigational New Drug (IND) application in November 2023 for a Phase II trial, OMN6 is being evaluated for its efficacy in treating hospital-acquired bacterial pneumonia (HABP) or ventilator-associated bacterial pneumonia (VABP) caused by Acinetobacter baumannii complex (ABC). These conditions represent severe infections where existing treatments often fail due to antimicrobial resistance, highlighting the urgent need for new therapeutic options.

Dr. Moshik Cohen-Kutner, CEO of Omnix Medical, expressed enthusiasm over the FDA’s recognition of OMN6’s potential, emphasizing the opportunity to expedite the development of this transformative anti-infective. Niv Bachnoff, CSO of Omnix Medical, also highlighted fast-track designation’s significance in advancing closer to providing lifesaving treatments for patients facing dire bacterial infections without effective therapeutic alternatives.

Fast-Track Designation

OMN6 with Fast-Track Designation, Target Superbug Threats

Founded in 2015, Omnix Medical has dedicated itself to overcoming the daunting challenge posed by antibiotic-resistant bacteria. The company’s proprietary technology leverages the innate immune system mechanisms of insects, employing unique molecules that efficiently and selectively eradicate resistant bacterial strains. This breakthrough approach, mimicking a system that has evolved over millions of years, positions Omnix Medical’s technology as a potential cornerstone in the battle against antimicrobial resistance (AMR).

OMN6 embodies a revolutionary class of antimicrobial drugs, inspired by insect host defense peptides, designed to counteract life-threatening infections caused by Gram-negative bacteria like Acinetobacter baumannii. Through Omnix Medical’s proprietary optimization, OMN6 has demonstrated exceptional efficacy, safety, and stability, promising a new era in antimicrobial therapy that transcends the limitations of current treatments and prevents the emergence of new resistances.


Resource: Biospace, February 20, 2024

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