Phase IIa trial of AFN 1252 (Affinium Pharma) shows drug is effective and safe against Bacterial Infections

Results from a Phase IIa clinical trial evaluating oral AFN 1252, from Affinium Pharma, in acute Bacterial Skin and Skin Structure Iinfections (ABSSSI), demonstrates the drug offers excellent efficacy and safety. This study involved 103 patients with infections due to Staphylococcus, dosed twice daily for 5-14 days. The results show that Day 3 Improvement was achieved in 94% of patients in the clinically evaluable and microbiologically-evaluable populations. Overall cure, defined as resolution of lesion at short term follow-up, was seen in 93% of patients.

Of the patients who received AFN 1252, 87 had evidence of Staphylococcus at baseline, 88 were clinically evaluable at end of treatment and 76 were microbiologically evaluable. Finally, treatment emergent adverse events related to study drug occurred in 67% of patients, of which 90% were mild or moderate. "It's very exciting to have an oral formulation of a new mechanism of action antibiotic that has such high potency against MRSA and a safety profile which is promising, particularly for longer term therapy," stated Dr. Vance Fowler, Professor of Medicine at Duke University Medical Center.