Affinium reports positive results from Phase IIa study of AFN-1252

21st March 2013 (Last Updated March 21st, 2013 18:30)

Affinium Pharmaceuticals has reported positive results from a Phase IIa study evaluating oral AFN-1252 in acute bacterial skin and skin structure infections (ABSSSI).

Affinium Pharmaceuticals has reported positive results from a Phase IIa study evaluating oral AFN-1252 in acute bacterial skin and skin structure infections (ABSSSI).

The antibiotic-targeting bacterial fatty acid biosynthesis inhibition, AFN-1252, demonstrated a significant efficacy, safety and tolerability profile.

Affinium Pharmaceuticals chief medical officer Dr Barry Hafkin said; "This clinical study in 103 patients from 18 centers in the US and Canada confirms excellent efficacy, safety and tolerability of 200mg of oral AFN-1252 dosed twice daily for 5-14 days in patients with acute bacterial skin and skin structure infections (ABSSSI) due to staphylococcus."

"The antibiotic-targeting bacterial fatty acid biosynthesis inhibition, AFN-1252, demonstrated a significant efficacy, safety and tolerability profile."

The patients enrolled in the study with a range of skin infections of greater than or equal to 75cm² in size, including severe abscesses, cellulitis and wound infections were recruited from outpatient or emergency room settings.

Most of the patients were treated with oral AFN-1252 as monotherapy in the outpatient setting.

The study reported that 94% of patients demonstrated day three improvement in the clinically evaluable (CE) and microbiologically-evaluable (ME) populations, while 93% of patients achieved overall cure.

The study reported treatment-emergent adverse events (TEAEs), such as headache, nausea and vomiting, in 67% patients.

A total of 87 patients, out of 103 treated, showed evidence of staphylococcus at baseline (MITT) and 88 were clinically evaluable at end of treatment, while 76 were microbiologically evaluable.

According to the study data, almost 50% of the S. aureus isolates were methicillin-resistant (MRSA).

Affinium CEO Dr Ed Mascioli said; "These data support the use of oral AFN-1252 as safe and rapid treatment of serious staphylococcal infections, including MRSA."