Tag: anti-infectives
Omnix Medical Receives U.S. FDA Approval of a Phase II Trial of its Next-Generation Anti-Infective OMN6
– Phase I data show safety and tolerability at clinically significant dose levels
– New class of anti-infectives to treat infections with Gram-negative bacteria
Omnix Medical, a biopharmaceutical company developing next-generation anti-infectives for the treatment of life-threatening infections, today announced that the U.S. Food and Drug Administration (FDA) has approved a planned Phase II trial of the Company´s novel anti-infective OMN6.
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.