AUSTIN, Texas and TORONTO, August 7, 2012 /PRNewswire/
Affinium Pharmaceuticals announced today that full recruitment has been achieved in its multi-center Phase 2 clinical trial evaluating oral AFN-1252 in acute bacterial skin & skin structure infections ("ABSSSI"). This Phase 2 trial is the first human efficacy study conducted with a new class of antibiotics designed to specifically inhibit staphylococcal fatty acid biosynthesis via a new drug target, the fatty acid synthase II (FASII) system. Results expected in late 2012 will represent a significant proof-of-concept milestone for this unique, Staphylococcus-specific antibiotic, AFN-1252.
The objectives of the study are to confirm efficacy, 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 and 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 potential pathogen or admitting the patient into hospital; yet, the majority of the patients were 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 treatment of serious staphylococcal skin infections. The exquisite potency of AFN-1252 against all strains of Staphylococcus including MRSA and VISA through a unique new mechanism 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 opinion 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 University of Chicago MRSA Research Center and Professor of Pediatrics, Microbiology and Molecular Medicine at the University of Chicago, Illinois, commented that "a staphylococcal specific antibiotic should have no off-target effect on gut flora and put no resistance selection pressure on other bacterial species, 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 multiple 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 potential 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 based on FabI inhibition. AFN-1252 is a well tolerated and highly potent agent that is active 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 either as monotherapy for confirmed staphylococcal infections or in combination when Staphylococcus is suspected in a variety of infections. The oral formulation is finishing Phase 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.
For more information, please see our website at: http://www.afnm.com
For further information:
Barry Hafkin, MD
Chief Medical Officer
Leisa Dennehy, MBA
Commercial & Corporate Development