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news.Affinium Pharmaceuticals has dosed first patient in a multi-center Phase 2 clinical trial investigating oral AFN-1252 in acute bacterial skin & skin structure infections (ABSSSI).
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AFN-1252, the clinical candidate from the company’s FASII program, is designed to selectively target the staphylococcal FabI enzyme.
The Phase 2 trial is designed to confirm efficacy and tolerability of 200 mg of oral AFN-1252 dosed twice daily for 5-14 days in patients with staphylococcal skin infections.
Earlier Phase 1 trials demonstrated safety, tolerability and pharmacokinetics of AFN-1252 in single and multiple ascending oral dosages.
The trial will also assess both the traditional endpoints at end of treatment and early endpoints currently recommended by the US Food and Drug Administration.
Affinium Pharmaceuticals chief medical officer Hafkin said they hope that the Phase 2 trial will confirm AFN-1252 as a potent and well tolerated anti-Staph antibiotic.
Affinium Pharmaceuticals Commercial & Corporate Development advisor Leisa Dennehy said AFN-1252 will provide physicians with a compelling alternative to vancomycin or linezolid in the treatment of known or suspected MRSA infections for patients where vancomycin or linezolid safety risks cannot be tolerated.