Shield Therapeutics PLC Completion of patient enrolment in Phase 3 study (1132T)
October 10 2017 - 2:00AM
UK Regulatory
TIDMSTX
RNS Number : 1132T
Shield Therapeutics PLC
10 October 2017
Shield Therapeutics plc
("Shield" or the "Group")
Completion of patient enrolment in pivotal AEGIS-CKD Phase 3
study
Top line data anticipated early in the first quarter of 2018
London, UK, 10 October 2017: Shield Therapeutics plc (LSE:STX),
a specialty pharmaceutical company focused on secondary care, today
announces the completion of enrollment of the pivotal Phase 3
AEGIS-CKD study of its European-marketed product, Feraccru(R).
Top-line data, based on the 16-week primary endpoint, is
anticipated early in the first quarter of 2018. Subjects were
enrolled in 30 renal centres across the USA.
A positive outcome from this study will enable initiation of the
regulatory filing with the US FDA that could lead to the
commercialisation of Feraccru in the US and increase the target
population for Feraccru from c. 330,000 Inflammatory Bowel Disease
(IBD) patients with Iron Deficiency Anaemia (IDA) in Europe to c.
2.6m patients with IDA related to both IBD and CKD in Europe and
the USA.
The study is evaluating Feraccru (ferric maltol, 30mg bd)
compared to placebo in the treatment of IDA in patients with
non-dialysis Chronic Kidney Disease (CKD). Feraccru is currently
approved in Europe for the treatment of IDA in adults with IBD.
Shield recently filed for approval of an expanded label for
Feraccru in Europe.
Dr Mark Sampson, Chief Medical Officer of Shield Therapeutics,
commented: "We are pleased to reach this important recruitment
milestone. Many CKD patients struggle to tolerate currently
available oral iron preparations, resulting in poor control of
their IDA. We look forward to the data early in the first quarter
of 2018 and to taking the next steps to make Feraccru available to
as many patients as quickly as possible. I would like to thank the
patients for their willingness to participate, as well as the
clinicians and colleagues who have worked so diligently on this
programme."
- Ends -
For further information please contact:
Shield Therapeutics plc +44 (0)207 186 8500
Dr Mark Sampson, Chief Medical Officer
Carl Sterritt, Chief Executive Officer
Karl Keegan, Chief Financial Officer
Nominated Advisor and Joint Broker +44 (0)203 100 2222
Liberum Capital Limited
Christopher Britton/Steve Pearce
Joint Broker +44 (0)207 418 8900
Peel Hunt LLP
James Steel/Dr Christopher Golden
Financial PR Advisor +44 (0)203 709 5700
Consilium Strategic Communications
Mary-Jane Elliott/Matthew Neal
US Investor Relations +1 (212) 867 1762
Lazar Partners
Fern Lazar/ David Carey
About Shield Therapeutics plc
Shield Therapeutics is a specialty pharmaceutical company
focused on the commercialisation and development of late-stage,
hospital-focused pharmaceuticals which address areas of unmet
medical need. Our clear purpose is to help our patients become
people again, by enabling them to enjoy the things that make the
difference in their everyday lives. The Group has a marketed
product, Feraccru(R), for the treatment of iron deficiency anaemia
(IDA) in adult patients with inflammatory bowel disease (IBD) which
has exclusive IP rights until the mid-2030's. Shield Therapeutics,
headquartered in London, is listed on LSE's AIM under the ticker
STX. For more information please visit
www.shieldtherapeutics.com.
About Feraccru(R)
Feraccru(R) is Shield's lead product and is a novel therapy for
the treatment of IDA. Feraccru(R) received marketing authorisation
across Europe in February 2016 for the treatment of IDA in adult
patients with IBD and is in the early stages of commercialisation
in European markets. The Group is currently completing a pivotal
Phase 3 clinical trial of Feraccru(R) in IDA patients with
pre-dialysis CKD and expects to announce results of this study
early in the first quarter of 2018. A positive result is expected
to facilitate the filing of an NDA for Feraccru(R) in the US as
well as significantly broader commercialisation in Europe and
beyond.
This information is provided by RNS
The company news service from the London Stock Exchange
END
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