Date: 2012-11-20
Type of information: Initiation of preclinical development
phase: 2a
Announcement: results
Company: Atox Bio (Israel)
Product: AB103
Action
mechanism: AB103 is a rationally designed short peptide acting as a CD28 modulator regulating the host’s inflammatory response.
Disease: necrotizing soft tissue infections (NSTI)
Therapeutic area: Infectious diseases
Country: USA
Trial
details: The trial evaluated two doses of AB103 versus placebo in 40 adult patients with NSTI enrolled at six leading medical centers across the U.S. AB103 was administered to 30 patients while 10 patients received placebo. All patients also received standard of care treatment for NSTI including surgical removal of necrotic tissue, antibiotics and supportive care.
Latest
news: Atox Bio has reported positive top-line results from the AB103 randomized, double-blind, placebo-controlled Phase 2a trial in patients with Necrotizing Soft Tissue Infections (NSTI). The trial demonstrated that patients treated with AB103 had a meaningful improvement across multiple endpoints measured in the trial compared to placebo. Patients treated with AB103 had a faster resolution of organ dysfunction, spent fewer days in ICU, required fewer days of assisted ventilation and needed fewer surgical procedures to remove infected tissue. In addition, systemic inflammatory biomarkers demonstrated a faster decline in treated patients compared to placebo, consistent with the drug’s mechanism of action. Atox Bio plans to present data from the trial at an upcoming major medical meeting.
AB103 was shown to be very well tolerated in the study with no major differences in rates of adverse events between the groups and without any adverse events that were related to the study drug.
Last September, the FDA has granted Fast Track designation to AB103.
