Ipsat Therapies Announces Positive Top-line Data from Phase IIb Study of Ipsat P1A
29-Oct-2007
Ipsat Therapies announced that the Ipsat P1A phase IIb study met both primary endpoints. Ipsat P1A is the most advanced of Ipsat's portfolio of beta-lactamases, specifically designed to inactivate residual amounts of antibiotics in the patients' gastrointestinal tract, after parenteral administration of beta-lactam antibiotics for serious infections.
The recently completed Phase IIb study was a randomised, placebo controlled, double blind, multi-center study in hospitalized patients treated with intravenous ampicillin for serious respiratory infections. It was designed to evaluate the preventative effect of oral administration of Ipsat P1A on the changes in intestinal microflora, development of antimicrobial resistance and gastrointestinal side effects induced by ampicillin. Group 1 (n=54) was treated with intravenous ampicillin and oral P1A, and group 2 (n=58) was treated with intravenous ampicillin and placebo.
Ampicillin treatment led to significant changes in intestinal microflora, with a reduction in 'similarity index' and an increase in the number of ampicillin-resistant coliforms compared to baseline. Administration of Ipsat P1A effectively prevented these effects, as demonstrated by a smaller decrease in similarity index in the treated group compared to placebo ( -27.2% vs -44.5%, respectively, p<0.001). Treatment with P1A also reduced the emergence of ampicillin-resistant coliforms by more than 3-fold compared to placebo (+ 12.7% vs + 40.2%, respectively, p< 0.001). The study therefore met primary end-points, in both intent-to-treat and per protocol populations.
P1A was well tolerated. The rate of overall adverse events was comparable between the two treatment groups. Four patients developed diarrhea, three in the placebo group and one in the treated group.
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