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news.Swiss-based global biopharmaceutical company Debiopharm has launched a Phase 1 dose-escalation study of Debio 1450, previously known as AFN-1720.
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The double-blind and placebo-controlled study will evaluate the safety, tolerability, and pharmacokinetics of single oral doses of Debio 1450 in healthy subjects.
Debio 1450 is an anti-infective agent that is selectively active against a large number of Staphylococcus species, including all known resistant strains such as methicillin-resistant S. aureus (MRSA) and vancomycin-intermediate S. aureus (VISA).
The study complements the IV single-ascending dose Phase I trial, which was recently presented at the 24th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID 2014).
Debio 1450 is a prodrug of Debio 1452, which has been successfully administered in a series of Phase I studies and a Phase 2 study wherein it demonstrated high efficacy in the treatment of acute bacterial skin and skin-structure infections (ABSSSI).
Debio 1450 is expected to preserve the human microbiota to reduce antibiotic-associated side effects such as antibiotic-induced diarrhea or C. difficile overgrowth due to its unique selectivity for staphylococcal species.
After both IV and oral administration in animals, Debio 1450 is converted to the active metabolite Debio 1452.
Debiopharm International medical affairs vice-president Jean-Maurice Dumont said, "This study is another step towards the development of an IV/oral anti-infective agent for difficult-to-treat infections."