Affinium Pharmaceuticals has dosed its first patient in a multi-center phase II clinical trial evaluating oral AFN-1252 in acute bacterial skin and skin structure infections. The phase II trial is the first human efficacy study conducted with this new class of antibiotic and follows the recently completed phase I trials, which demonstrated excellent safety, tolerability and pharmacokinetics of AFN-1252 in single and multiple ascending oral dosages.
The phase II study will confirm efficacy and tolerability of 200mg of oral AFN-1252 dosed twice daily for five to 14 days in patients with staphylococcal skin infections. The trial will also evaluate both the traditional endpoints at end of treatment and early endpoints currently recommended by the FDA.
"A staphylococcal-specific antibiotic provides the unique benefits of no off-target effects on gut flora and no resistance selection pressure on other bacterial species which greatly reduces the probability of antibiotic associated adverse events such as C. difficile disease, diarrhea or candidiasis, while providing high potency against the desired target,” said Nachum Kaplan, Ph.D., vice president of microbiology at Affinium. “AFN-1252 is like no other antibiotic ever developed, and we look forward to having the phase II data later this year.”