Shield Therapeutics PLC PT20 paper publication
July 16 2020 - 2:05AM
RNS Non-Regulatory
TIDMSTX
Shield Therapeutics PLC
16 July 2020
Shield Therapeutics plc
("Shield" or the "Group" or the "Company")
PT20 paper publication
Demonstrates statistically significant and dose-dependent
reduction in serum phosphate concentration
London, UK, 16 July 2020: Shield Therapeutics plc (LSE: STX), a
commercial stage, pharmaceutical company with a focus on addressing
iron deficiency with its lead product Feraccru (R) /Accrufer(R)
(ferric maltol), notes the recent publication in Nephrology
Dialysis Transplantation of a paper concerning PT20, Shield's
iron-based phosphate binder.
PT20 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 PT20, 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 PT20
treatment were evaluated in patients with dialysis-dependent CKD.
Participants were randomly assigned to receive PT20 or placebo
three times daily. 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 paper is available online here:
https://academic.oup.com/ndt/advance-article/doi/10.1093/ndt/gfaa116/5870136?guestAccessKey=88a1458d-6ef5-4e88-adcf-cf016a475be8
Shield 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. Shield will first
develop a new formulation of PT20 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.
For further information please contact:
Shield Therapeutics plc www.shieldtherapeutics.com
Tim Watts, CEO +44 (0)20 7186 8500
Karen Chandler Smith, Investor
Relations
Nominated Adviser and Joint
Broker
Peel Hunt LLP
James Steel/Dr Christopher
Golden +44 (0)20 7418 8900
Joint Broker
finnCap Ltd
Geoff Nash/Matt Radley/Alice
Lane +44 (0)20 7220 0500
Financial PR & IR Advisor
Walbrook PR +44 (0)20 7933 8780 or shield@walbrookpr.com
+44 (0)7980 541 893 / +44 (0)7584 391
Paul McManus/Lianne Cawthorne 303
About Shield Therapeutics plc
Shield is a de-risked, specialty pharmaceutical company focused
on commercialising its lead product, Feraccru(R)/Accrufer(R), a
novel, stable, non-salt based oral therapy for adults with iron
deficiency with or without anaemia. Feraccru(R)/Accrufer(R) has
been approved for use in the United States, European Union, UK and
Switzerland and has exclusive IP rights until the mid-2030s.
Feraccru is commercialised in the UK and Europe by Norgine B.V. and
the Company is currently in the process of selecting a
commercialisation partner for the US market. Shield also has an
exclusive licence agreement with Beijing Aosaikang Pharmaceutical
Co., Ltd., for the development and commercialisation of
Feraccru(R)/Accrufer(R) in China, Hong Kong, Macau and Taiwan.
For more information, please visit www.shieldtherapeutics.com .
Follow Shield on Twitter @ShieldTx
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END
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