Phase IIb results were published in July for Shield Therapeutics’ oral iron-based phosphate binder PT20 for the treatment of hyperphosphatemia (HPT) in dialysis-dependent chronic kidney disease (CKD) patients. Although the CKD-HPT market has several marketed treatments available, PT20 has the potential to capture a slice of the HPT market by targeting dialysis-dependent patients who are not able to maintain recommended phosphate levels, despite treatment and adhering to restricting dietary phosphate intake, according to GlobalData, a leading data and analytics company.

Jesse Cuaron, Associate Director at GlobalData, commented: “Overall, PT20 was efficacious and generally well tolerated in its Phase IIb results, with Shield Therapeutics eyeing a Phase III study in the coming years. In 2019, a Phase III study was anticipated to begin in 2021, following the development of a new formulation of PT20. However, trial initiation has now been pushed back to 2022, which will directly follow the completion of the new formulation, which is expected to start in H2 2020 and last 15–18 months.”

GlobalData believes if PT20 sustains such an apparently beneficial efficacy profile from its planned Phase III trial, then it could be of high clinical value to future patients against in-family iron-based binders, Vifor’s Velphoro (sucroferric oxyhydroxide) and Akebia Therapeutics’ Auryxia (ferric citrate). With that said, PT20 will be entering a highly competitive and crowded market, filled with established metal- and non-metal-based binders.

Cuaron concludes: “There is also the potential threat from Ardelyx’s tenapanor, an inhibitor of sodium/hydrogen exchanger isoform 3 (NHE3). Ardelyx announced the NDA submission to the FDA for tenapanor in June for treating HPT in adult CKD patients on dialysis.”