RDX5791 is a potent and selective inhibitor of NHE3, a sodium transporter on the surface of the intestinal epithelia. RDX5791 is being studied in two different settings: (i) the management of fluid overload and dietary sodium restriction in kidney and heart disorders such as end-stage renal disease / hemodialysis (ESRD/HD), chronic kidney disease (CKD), and heart failure (HF) and (ii) the treatment of constipation disorders such as constipation-predominant irritable bowel syndrome (IBS-C).
RDX5791 has been evaluated to date in three clinical trials involving a total of 371 subjects including 285 subjects who were administered the drug at various doses and regimens in different settings:
· RDX5791-101: a single-dose ascending portion followed by a multiple-ascending dose portion in 80 subjects with the primary goal to determine the safety of RDX5791 in healthy adult volunteers;
· RDX5791-102: a 7-day dose-regimen clinical study in 105 subjects to determine how best to administer RDX5791 to bring about different levels of sodium diversion while controlling stool form; and
· RDX5791-201: a Phase 2, 4-week clinical study evaluating RDX5791 once daily in 186 patients with IBS-C.
In all cases, RDX5791 was well-tolerated with rates of adverse events similar to that seen with placebo including gastrointestinal adverse events such as diarrhea. The biological effects of RDX5791 support the proposed mechanism of RDX5791: the prevention of sodium absorption and the diversion of sodium into the stool along with water from the body.
For more information on the AstraZeneca collaboration click here