AST-120: Phase II data

Data from a double-blind Phase II trial in 115 patients showed that AST-120 produced a 32% response rate, defined as a >=50% reduction from baseline in days with pain, vs. 25% for placebo at week 8. Response rates at week 4 were 27% for AST-120 vs. 10% for placebo (p=0.029). AST-120 also reduced mean pain VAS scores at week 4 by 11 mm vs. 6 mm for placebo. Additionally, AST-120 significantly reduced bloating severity at week 2 (p=0.007) and week 4 (p=0.002) vs. placebo. AST-120 was well tolerated with fewer adverse events compared to placebo.

In a retrospective analysis evaluating endpoints specified in FDA's recent draft guidance on the design of clinical trials for diarrhea- or constipation-predominant irritable bowel syndrome (IBS-D or IBS-C), AST-120 produced response rates of 23% and 34% for pain reduction and improvement in stool consistency, respectively, vs. 13% and 17% for placebo at week 4. The study consisted of an 8-week, double-blind, placebo-controlled trial, followed by a 2-week, single-blind placebo washout phase and an 8-week, single-blind AST-120 treatment phase. Data were presented at the Digestive Disease Week meeting in New Orleans. ...