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news.Affinium Pharmaceuticals has announced full recruitment in Phase 2 trial of AFN-1252 in acute bacterial skin & skin structure infections (ABSSSI).
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The study, conducted with a new class of antibiotics designed to inhibit staphylococcal fatty acid biosynthesis by means of a new drug target, the fatty acid synthase II (FASII) system, will assess the efficacy, safety and tolerability of 200mg of oral AFN-1252.
The 200mg of oral AFN-1252 will be dosed twice daily for five to fourteen days in patients with suspected staphylococcal skin infections recruited in the outpatient or emergency room settings.
Affinium chief medical officer Dr. Barry Hafkin said 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," Dr. Hafkin added.
The results of the trial, which will evaluate both the traditional endpoints at end of treatment and early endpoints currently recommended by the FDA, are expected in late 2012.