Paris based Sanofi has pulled out of a €176M deal with Californian clinical stage biotech Ardelyx. A licensing deal for a program of pre-clinical candidates treating renal diseases and IBS-C, similar to Tenapanor, was revoked.
In February 2015, Fresno County’s Ardelyx announced its pharma-baby, Tenapanor, had passed its stage IIB clinical trials in successfully reducing serum levels of phosphate. Excess phosphate in circulation can be a result of renal failure and certain endocrine disorders. If allowed to accumulate, it can cause various other imbalances, including hypocalcemia, therefore resulting in conditions such as renal osteodystrophy.
Tenapanor works as an inhibitor of phosphate carrier molecules, such as the NaP2b protein, which is primarily expressed in the upper intestinal tract. Its safety is partly attributed to its ability to remain within the lumen of the gut without absorption, up to 98% of which is eventually excreted (as shown in rats). It has been developed as a treatment for chronic kidney disease patients on dialysis, end-stage renal disease (ESRD) and also irritable bowel syndrome (specifically IBS-C).