Omnix Medical has received approval from the US Food and Drug Administration (FDA) for a Phase II trial of its next-generation anti-infective OMN6.
OMN6 is a new and first-in-class antimicrobial peptide (AMP) that is based on insect host defence peptides. It has a mechanism of action (MoA) that relies on a completely innovative principle against conventional anti-infectives.
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The multicentre and multinational study will evaluate OMN6’s pharmacokinetics and safety in subjects with ventilator-associated bacterial pneumonia (VABP) or hospital-acquired bacterial pneumonia (HABP) caused by Acinetobacter baumannii complex (ABC).
OMN6 has shown better tolerability and safety at clinically significant dose levels in a placebo-controlled, double-blind, randomised, and single-ascending dose Phase I trial involving more than 80 healthy volunteers.
Moreover, the drug’s complete clearance could be demonstrated, enabling multiple daily infusions, a common practice in anti-infective treatments.
Omnix Medical CEO Dr Moshik Cohen-Kutner said: “We are very pleased that the US FDA has approved our planned Phase II study.
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By GlobalData“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.”
The proprietary technology of Omnix eradicates bacteria by mimicking the innate immune system of insects.
It employs distinct molecules to eliminate resistant bacterial strains specifically, all without causing harm.
The company is developing its lead compound to treat severe hospital-acquired infections (HIA) and has demonstrated effectiveness than existing treatments.
