The objectives of the study are to confirm efficac y, safety and tolerability of 200 mg of oral AFN-1252 dosed twice daily for 5-14 days in patients with serious, suspected staphylococcal skin infections recruited in the outpatient or emergency room settings. The trial evaluates both the traditional endpoints at end of treatment a nd early endpoints currently recommended by the FDA.
"We are delighted with the ease and rate of patient recruitment in our study," said Dr. Barry Hafkin, Chief Medical Officer at Affinium. Dr. Hafkin noted that investigators had the option of adding a second antibiotic to cover any other pot ential pathogen or admitting the patient into hospital; yet, the majority of the patients we re treated with AFN-1252 as monotherapy in the outpatient setting. "We believe this study demonstrates investigators' confidence in identifying staphylococcal skin infection and using AFN-1252 in the treatm ent of serious staphylococcal skin infections. The exquisite potency of AFN-1252 agains t all strains of Staphylococcus including MRSA and VISA through a unique new m echanism of action, and the excellent safety profile demonstrated in multiple oral Phase 1 studies were attributes that excited our clinical investigators," Dr. Hafkin noted.
According to Leisa Dennehy, Commercial & Corporate Development Advisor at Affinium, "Practicing physicians and key opi nion leaders consistently remark that a specific-spectrum agent has unique and important benefits that no other antibiotic has ever been able to offer." Robert Daum, M.D., Director of the Univers ity of Chicago MRSA Research Center and Professor of Pediatrics, Microbiology and Molecular Medicine at the University of Chicago, Illinois, commented: "A staphylococcal specific antibiotic should have no off-target effect on gut flora and put no resistance selection pressure on other bacterial spec ies, which may greatly reduce the probability of antibiotic associated adverse events such as C. difficile disease, diarrhea or candidiasis. The incredible potency against all strains of Staphylococcus combined with an excellent safety profile demonstrated in multip le oral Phase 1 makes AFN-1252 an exciting new product for treatment of staphylococcal infections."
About Staphylococcal Infections
Each year in the US, more people die from staphylococcal infections that from HIV. Skin infections alone account for more ten million patient visits in the US. Staphylococcus is the mostly commonly identified bacterium in skin infections and is a poten tial pathogen in almost every infection type, making staphylococci the most common bacterial pathogen in a large and diverse patient population.
AFN-1252 is the lead clinical-stage agent in a new class of antibiotics base d on FabI inhibition. AFN-1252 is a well tolerated and highly potent agent that is ac tive against all strains of Staphylococcus, including all known resistant strains such as methicillin-resistant S.aureus (MRSA) and vancomycin-intermediate S.aureus (VISA). Because AFN-1252 is specifically designed to be active against only Staphylococcus sp., it may provide the unique safety benefit of no off-target side effects, such as antibiotic-induced diarrhea or resistance pressure on other bacteria. AFN-1252 has potential to be used eith er as monotherapy for confirmed staphylococcal infections or in combination when Staphylococcus is suspected in a variety of infections. The oral formulation is finishing Ph ase 2a, and the IV formulation is completing pre-clinical studies in 2012.
About Affinium Pharmaceuticals
Affinium Pharmaceuticals is a specialty pharmaceutical company focused on the development of novel anti-infective medicines. The Affinium fatty acid synthesis ("FASII") antibacterial program constitutes a new antibiotic franchise with the potential for multiple patented products targeting the FASII pathway in various bacteria.