IPSAT P1A, a class A beta-lactamase therapy for the prevention of penicillin-induced disruption to the intestinal microflora

Abstract

Ipsat Therapies Oy is developing IPSAT (intestinal protection system in antibiotic treatment) P1A, a class A beta-lactamase therapy that targets the penicillins to reduce the antibiotic concentration in the intestines, to prevent adverse effects on the normal enteric flora (eg, overgrowth of pathogenic bacteria and selection of antimicrobial resistance). In preclinical studies, IPSAT P1A, when administered with either ampicillin or piperacillin, inactivated these beta-lactam penicillin antibiotics in the jejunum of animals, with no effect on the mean serum ampicillin or piperacillin concentrations. Furthermore, IPSAT P1A demonstrated efficacy in phase IIb clinical trials by degrading ampicillin-antibiotic residues in the gastrointestinal tract of both healthy volunteers and hospitalized patients. At the time of publication, IPSAT P1A had completed a phase I trial in France, a phase IIb trial in Russia and Ukraine, and a phase IIa trial in Estonia. Based on the preliminary clinical data, the author concludes that IPSAT P1A is effective in humans, and the combination of this beta-lactamase with a beta-lactam antibiotic could potentially limit the overgrowth and selection of pathogens that colonize the intestinal tract.