Shield Therapeutics (AIM:STX) has published a paper showing the efficacy of PT20 as a treatment for people with hyperphosphatemia, a common complication of chronic kidney disease.
The paper, which has been published in ‘Nephrology Dialysis Transplantation’, showed results from a Phase IIb study for the company’s novel iron-based phosphate binder, PT20.
PT20 has the potential to treat patients with hyperphosphatemia, a condition where due to renal failure there is too much phosphorus present in the blood. The condition can be related to either dialysis or non-dialysis dependent chronic kidney disease (CKD).
The Phase IIb study, which was funded by Shield, was a double-blind, parallel-group, placebo-controlled, dose-ranging study in which the efficacy and safety of 28 days of oral PT20 treatment were evaluated in patients with dialysis-dependent CKD, it detailed.
Participants were randomly assigned to receive PT20 or placebo three times daily.
Shares in Shield Therapeutics opened flat at 82p on Wednesday afternoon.
The Phase IIb study showed that 28 days of PT20 treatment “resulted in a statistically significant and dose-dependent reduction in serum phosphate concentration and was generally well tolerated.”
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 Shield first developing 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 is expected to 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.
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