Ardelyx and Kyowa’s tenapanor therapy for hyperphosphatemia (HP) in chronic kidney disease (CKD) patients who are on dialysis is likely to gain a front-line position in the CKD-HP market due both to its novel mechanism of action (MoA) and its opportunity to address low patient compliance for those on HP monotherapy and the need for therapies targeting refractory CKD-HP – two long-standing unmet needs in the space, according to GlobalData, a leading data and analytics company.

Key Opinion Leaders (KOL) interviewed by GlobalData believe that tenapanor monotherapy and combination therapy would prove extremely useful in treating CKD-HP, as the former would help improve patient compliance by reducing pill burden, while the latter would provide a dual mechanism approach in treating refractory CKD-HP patients.

Jesse Cuaron, Associate Director at GlobalData, commented: “The market has historically been crowded with phosphate binders, which require patients to ingest a large number of tablets or capsules per day with each meal. In addition, the therapy default has been a single mechanism approach because there has not been another drug with a significantly differing MoA for treating CKD-HP. This will provide tenapanor with a huge advantage and we expect the drug to have a positive uptake.

“The companies will, of course, need to have a strong marketing campaign in the US, as a SoC already exists. However, given its novel MoA, it will likely have a better chance in competition against incumbent therapies given its first in class status.”

Tenapanor’s Phase III PHREEDOM study demonstrated that the drug was both efficacious and safe. Specifically, there were sustained reductions in serum phosphorus concentrations and a decrease in mean serum phosphorus. Kyowa announced similar results were achieved in Phase II studies in Japan. Furthermore, the BLOCK and AMPLIFY Phase III trials showed that tenapanor was efficacious both when administered as a monotherapy or when used with phosphate binders in treating refractory HP patients. Additionally, analyses of the PHREEDOM, BLOCK, and AMPLIFY trials showed that tenapanor was well tolerated across the studies.