Omnix Medical Granted Fast-Track Designation by U.S. FDA for its Next-Generation Anti-Infective OMN6
– Designation underlines the need for novel, first-in-class antimicrobials for the treatment of 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 Company has received fast-track designation for its novel anti-infective OMN6 from the U.S. Food and Drug Administration (FDA). Fast track expedited review is designated to investigational drugs that treat a serious or life-threatening condition and fill an unmet medical need.
– First dose level rated as safe by independent Data Safety Monitoring Board
– Second dose level to be administered according to plan
– THE001 designed as targeted tumor treatment independent of specific molecular targets or tumor subtypes
Thermosome, a drug development company specializing in targeted tumor therapies, today announced that it received clearance by the independent Data Safety Monitoring Board (DSMB) to proceed as planned with the dose escalation in its ongoing Phase I trial of its lead program THE001. The first dose level was safe and well tolerated as assessed by the DSMB.
— Results of clinical trial CT-05 in 131 hospitalized patients with COVID-19
— Trial data demonstrate that MetrioPharm´s lead compound MP1032 has comparable efficacy to remdesivir with several additional benefits
— Results have been published in The Lancet Regional Health – Europe
MetrioPharm AG, a biotech company developing drugs for inflammatory and infectious diseases, announced today that results from its clinical trial CT-05 in hospitalized patients with moderate to severe COVID-19 have been published in the renowned journal The Lancet Regional Health – Europe.