Interim data from tenapanor’s OPTIMIZE trial signals promising treatment option for CKD-HP, says GlobalData

Ardelyx presented interim data from its ongoing OPTIMIZE study at the European Renal Association. The primary endpoint of the Phase IV OPTIMIZE study is to evaluate the use of tenapanor as the main therapy option for chronic kidney disease (CKD)–hyperphosphatemia (HP) patients on dialysis. Tenapanor is expected to gain a front-line position in the CKD -HP market due both to its novel mechanism of action and its opportunity to improve patient compliance by reducing pill burden, according to GlobalData, a leading data and analytics company.

Kajal Jaddoo, Pharma Analyst at GlobalData, comments: “Key opinion leaders (KOLs) interviewed by GlobalData have emphasized tenapanor’s potential to be an alternative therapy option to traditional phosphate binders such as sevelamer, while also offering a smaller pill size and not requiring mealtime administration.”

Interim data from the company’s ongoing OPTIMIZE study show that tenapanor proved to achieve greater phosphorus targets in binder-treated patients with phosphorus greater than 5.5mmol/L. Furthermore, tenapanor can help control serum phosphorus in binder-naïve patients.

Jaddoo continues: “Despite these results, some KOLs based in the US have stated that in general, monotherapy for treating high phosphate doesn’t work, and hence tenapanor will likely have to be integrated into existing HP treatment paradigms. KOLs further emphasized that if tenapanor is approved, a prior authorization might be put in place in prescription plans and so patients would have to have failed a traditional guideline-recommended therapy in order to get it.

“Despite the advantageous clinical data on tenapanor, the drug is expected to enter the mature dialysis market and will likely face notable barriers in entry against marketed iron-based binders, as well as the dominant cheaper calcium-based binders.”

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