Shield Therapeutics PLC (LON:STX) has published a paper highlighting a study into the benefits of PT20 as a treatment for people with the kidney disease hyperphosphatemia.
Published recently in Nephrology Dialysis Transplantation, the paper detailed the results of a phase IIb study for PT20, an iron-based phosphate binder.
Hyperphosphatemia is a condition where due to renal failure there is too much phosphorus present in the blood.
Shield said that the study demonstrated that PT20 treatment for 28 days resulted in a statistically significant and dose-dependent reduction in serum phosphate concentration and was generally well tolerated.
The study, which was funded by Shield, was a pivotal study to support marketing authorisation submissions, it added.
Shield said it has agreed with the US FDA that PT20 requires only one further pivotal Phase III study after which regulatory filings for marketing approval would be expected to follow.
This will involve the development of a new formulation of PT20, which will allow the Phase III study to be carried out and which will be suitable for commercial use.
Formulation work could start in the second half of 2020, Shield added, which would potentially allow the Phase III study to start in 2022, subject to finance being available.