Affinium Pharmaceuticals, a specialty pharmaceutical company, has completed recruitment for a Phase II trial of AFN-1252 in acute bacterial skin and skin structure infections.
The human efficacy study is 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 system.
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. However, 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 said.
"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 I studies were attributes that excited our clinical investigators."
The study is designed to assess the efficacy, safety and tolerability of 200mg of oral AFN-1252 dosed twice daily for five to 14 days in patients with serious, suspected staphylococcal skin infections recruited in outpatient or emergency room settings.
The results of the trial, which evaluates both the traditional endpoints at end of treatment and early endpoints currently recommended by the FDA, are expected in late 2012.
The University of Chicago MRSA Research Center director, professor of paediatrics, microbiology and molecular medicine Dr Robert Daum said; "The incredible potency against all strains of staphylococcus combined with an excellent safety profile demonstrated in multiple oral Phase I makes AFN-1252 an exciting new product for treatment of staphylococcal infections."