PT 20 iron-based phosphate binder study is published in Nephrology Dialysis Transplantation.-Shield Therapeutics

Shield Therapeutics plc a commercial stage, pharmaceutical company with a focus on addressing iron deficiency with its lead product Feraccru/Accrufer (ferric maltol), notes the recent publication in Nephrology Dialysis Transplantation of a paper concerning PT 20, Shield’s iron-based phosphate binder.

PT 20 is a novel iron-based phosphate binder that has the potential to treat patients with hyperphosphatemia (when there is too much phosphorus present in the blood) related to dialysis or non-dialysis dependent chronic kidney disease (CKD). The publication Nephrology Dialysis Transplantation has published a paper entitled “Efficacy and safety of PT 20, an iron-based phosphate binder, for the treatment of hyperphosphataemia: a randomized, double blind, placebo-controlled, dose-ranging, Phase IIb study in patients with haemodialysis-dependent chronic kidney disease.” The study, which was funded by Shield, was a pivotal study to support marketing authorisation submissions and was a double-blind, parallel-group, placebo-controlled, dose-ranging study in which the efficacy and safety of 28 days of oral PT 20 treatment were evaluated in patients with dialysis-dependent CKD. Participants were randomly assigned to receive PT 20 or placebo three times daily. The study demonstrated that PT 20 treatment for 28 days resulted in a statistically significant and dose-dependent reduction in serum phosphate concentration and was generally well tolerated.

Shield has agreed with the FDA that PT 20 requires only one further pivotal Phase III study after which regulatory filings for marketing approval would be expected to follow. Shield will first develop a new formulation of PT 20 which will allow the Phase III study to be carried out and which will be suitable for commercial use. It is anticipated that the formulation work could start in the second half of 2020 which would potentially allow the Phase III study to start in 2022, subject to finance being available.

See- “Efficacy and safety of PT 20, an iron-based phosphate binder, for the treatment of hyperphosphataemia: a randomized, double-blind, placebo-controlled, dose-ranging, Phase IIb study in patients with haemodialysis-dependent chronic kidney disease”- Mark Sampson, Nuno Faria, Jonathan J Powell on behalf of the PEACH study investigators
Nephrology Dialysis Transplantation, gfaa116, https://doi.org/10.1093/ndt/gfaa116.