Ardelyx Inc (ARDX)

[Whalatane]

Some random thoughts
My wife is a Renal PA . Most of her patients are on dialysis .
All of her patients hate the current standard of care for trying to maintain serum phosphorus levels below 5.5 mg/dl
...multiple tablets with every meal .
Non compliance is a huge problem .

So the results from the current study are really important for dialysis patients as it offers the possibility that they can dial back the number of phosphate binders they are currently required to take ....replacing these tablets with 2 small twice a day pills.

Some background /comments
There are around 700,000 dialysis patients in the US,EU,Japan combined .
85% of them need phosphate binders to try and get their serum phosphorus levels around 5.5 mg/dl
In the current study only 3 of the 116 patients in the active arm ( Tenapanor and binders ) discontinued the trial due to loose stool / diarrhea .
Most dialysis patients complain of constipation and may only have 2-3 bowel movements per week. While adding Tenapanor may increase the number of bowel movements to 5-6 times a week ...this will be seen by mostly as a good thing for these patients as it represents normal life pre dialysis.

The concern about loose stool etc in these patients is IMHO largely exaggerated.

Company has a market cap today of around $330m and reminds me a lot of the companies like ZS Pharma and RLYP that developed hyperkalemia drugs for the dialysis population .
Both were eventually brought out by BP at far higher prices .

Risks near term
Company will need financing ...either before or after their final P 3 ...results in Q4
Monotherapy trial ...the final P 3... may have bigger issues with loose stool etc .
The current binders patients are on create constipation ...when Tenapanor is added the loose stool side effect offsets this constipation creating a sense of more normal bowel movements .
In Monotherapy ( only Tenapanor ) there will be no "constipation offset " ...so loose stool / diarrhea may be a bigger issue .

JMO ...I'm adding or any significant sell offs
Kiwi