Welcome!

News Feed Item

Shield Therapeutics' ST10 Delivers Robust Results Meeting both Primary and Secondary Endpoints in the Pivotal AEGIS Phase 3 Programme for the Treatment of Iron Deficiency Anaemia in Inflammatory Bowel Disease

LONDON, January 7, 2014 /PRNewswire/ --

~ ST10 strongly demonstrates potential to be (1) the only effective oral treatment for ferrous intolerant IDA patients and (2) an effective alternative to intravenous iron treatment ~

Shield Therapeutics (Shield), an independent specialty pharmaceutical company focused on the development of mineral-derived hospital pharmaceuticals, today announces strongly positive top-line data from the pivotal Phase 3 programme of ST10 for the treatment of iron deficiency anaemia (IDA) in inflammatory bowel disease (IBD).  

ST10, a novel orally-dosed form of ferric iron, delivered a mean improvement in haemoglobin levels of 2.3g/dL (p <0.0001), clearly meeting the primary endpoint of haemoglobin change after 12 weeks' treatment compared to placebo.  More than 65% of treated subjects experienced normalised haemoglobin levels by week 12 and ST10 also rapidly delivered significant improvements in haemoglobin at 4 weeks (1.1g/dL, p <0.0001) and 8 weeks (1.8g/dL, p <0.0001) of therapy.  From a safety perspective, ST10 did not adversely affect IBD symptoms in treated subjects and was well tolerated for the duration of exposure.

The two AEGIS protocols recruited 128 patients with anaemia secondary to either Crohn's disease or ulcerative colitis who had previously failed therapy with oral ferrous products due to intolerance and/or inadequate therapeutic benefit.  Patients were recruited from expert centres in Austria, Germany, Hungary and the UK and were randomised (1:1) to receive ST10 or a matched placebo capsule.  Other iron therapies were not permitted during the study.  Adverse events recorded during the study were mainly gastrointestinal in nature and occurred in the ST10-treated arm with placebo-like frequency (38% of ST10-treated subjects and 40% of placebo-treated subjects).  Withdrawal from the study before 12 weeks (due to adverse events or subject decision) occurred in seven ST10-treated and nine placebo-treated subjects.  Patients who completed the 12-week double-blind phase of the study continued treatment in a 12-month open-label extension phase and results of this will be available later this year.

These results provide confirmatory pivotal clinical data which will form the basis of a Marketing Authorisation Application submission to the European regulatory authorities during 2014.  In conjunction with data that will be generated from the study of ST10 in the treatment of IDA in pre-dialysis chronic kidney disease patients that is currently progressing, these results will also form part of a subsequent New Drug Application submission to the FDA in the USA.

Full findings from the AEGIS studies will be presented at scientific congresses in due course.  

Commenting on the results, Professor Christoph Gasche, Professor of Medicine, Medical University of Vienna, Austria, said:

"I have studied the problem of anaemia in inflammatory bowel disease (IBD) patients for many years, and the data from the AEGIS studies are very encouraging.  Until now there has been no acceptable oral iron treatment available for the majority of my IBD patients with iron deficiency anaemia.  These results are statistically very convincing and the 2.3 g/dL rise in haemoglobin at 12 weeks together with the more than 1.1g/dL rise in haemoglobin at 4 weeks compared to placebo are clinically meaningful for anaemic patients.  The safety results from this study also show that ST10 is well tolerated with just a very small number of subjects withdrawing because of adverse effects and the frequency of GI side effects was similar in the placebo and ST10 groups.  My personal experience of the patients that I treated in this study fits with these results."

Also commenting on the results, Dr Tariq Ahmad, Consultant Gastroenterologist at the Royal Devon and Exeter Foundation Trust, Exeter, UK, said:

"Iron deficiency anaemia is a real problem for many of my patients.  Unfortunately patients often struggle with GI side effects caused by conventional ferrous iron salts.  Currently we offer such patients intravenous iron in hospital.  This is costly to administer, inconvenient for patients and associated with a small but significant risk of anaphylaxis.  The exciting AEGIS Phase 3 data suggests that ST10 will provide an effective, safe and more convenient alternative to intravenous iron for this group of patients as demonstrated by ST10 keeping our patients out of the infusion room by correcting and maintaining their haemoglobin in the normal range."

Shield's Founder and Chief Executive Officer, Carl Sterritt, commented:

"Delivering such resoundingly positive findings from these pivotal trials of ST10 in IBD is a tremendous achievement for Shield; and the whole team is indebted to the patients and investigators who participated in the protocols.  Our next aim is to make this therapy available as quickly as possible on a commercial basis to as wide an audience of prescribers and patients as we can, so we will be working diligently with regulatory authorities to achieve this goal.  

"The results reflect an important milestone in the development of ST10 as the only effective, low-dose oral iron-replacement therapy without the significant GI side-effects of ferrous iron or the high risks associated with intravenous administration of iron.  ST10 presents a significant opportunity for Shield to develop a paradigm changing treatment that will address a broad range of indications with a strong commercial potential and we look forward to rapidly advancing the programme."

About Shield Therapeutics

Shield Therapeutics (http://www.shieldtherapeutics.com), founded in 2008, is an independent specialty pharmaceutical company focused on the development and commercialisation of late-stage, mineral-derived hospital pharmaceuticals which address areas of high unmet medical need.  Shield has successfully completed a pivotal Phase 3 programme of its lead asset, ST10, for the treatment of iron deficiency anaemia associated with inflammatory bowel disease and is soon to commence a Phase 3 study of ST10 for the treatment of iron deficiency anaemia in patients with chronic kidney disease.

For more information about Shield Therapeutics, please contact:

Shield Therapeutics
Carl Sterritt, Chief Executive Officer
Tel +44(0)20-7186-0360

Consilium Strategic Communications
Mary-Jane Elliott / Emma Thompson / Lindsey Neville
Tel +44(0)20-7920-2333

Email: shieldtherapeutics@consilium-comms.com


More Stories By PR Newswire

Copyright © 2007 PR Newswire. All rights reserved. Republication or redistribution of PRNewswire content is expressly prohibited without the prior written consent of PRNewswire. PRNewswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

Latest Stories
"We want to show that our solution is far less expensive with a much better total cost of ownership so we announced several key features. One is called geo-distributed erasure coding, another is support for KVM and we introduced a new capability called Multi-Part," explained Tim Desai, Senior Product Marketing Manager at Hitachi Data Systems, in this SYS-CON.tv interview at 20th Cloud Expo, held June 6-8, 2017, at the Javits Center in New York City, NY.
"We provide IoT solutions. We provide the most compatible solutions for many applications. Our solutions are industry agnostic and also protocol agnostic," explained Richard Han, Head of Sales and Marketing and Engineering at Systena America, in this SYS-CON.tv interview at @ThingsExpo, held June 6-8, 2017, at the Javits Center in New York City, NY.
"With Digital Experience Monitoring what used to be a simple visit to a web page has exploded into app on phones, data from social media feeds, competitive benchmarking - these are all components that are only available because of some type of digital asset," explained Leo Vasiliou, Director of Web Performance Engineering at Catchpoint Systems, in this SYS-CON.tv interview at DevOps Summit at 20th Cloud Expo, held June 6-8, 2017, at the Javits Center in New York City, NY.
21st International Cloud Expo, taking place October 31 - November 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA, will feature technical sessions from a rock star conference faculty and the leading industry players in the world. Cloud computing is now being embraced by a majority of enterprises of all sizes. Yesterday's debate about public vs. private has transformed into the reality of hybrid cloud: a recent survey shows that 74% of enterprises have a hybrid cloud strategy. Me...
SYS-CON Events announced today that DXWorldExpo has been named “Global Sponsor” of SYS-CON's 21st International Cloud Expo, which will take place on Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. Digital Transformation is the key issue driving the global enterprise IT business. Digital Transformation is most prominent among Global 2000 enterprises and government institutions.
SYS-CON Events announced today that Datera, that offers a radically new data management architecture, has been named "Exhibitor" of SYS-CON's 21st International Cloud Expo ®, which will take place on Oct 31 - Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. Datera is transforming the traditional datacenter model through modern cloud simplicity. The technology industry is at another major inflection point. The rise of mobile, the Internet of Things, data storage and Big...
Kubernetes is an open source system for automating deployment, scaling, and management of containerized applications. Kubernetes was originally built by Google, leveraging years of experience with managing container workloads, and is now a Cloud Native Compute Foundation (CNCF) project. Kubernetes has been widely adopted by the community, supported on all major public and private cloud providers, and is gaining rapid adoption in enterprises. However, Kubernetes may seem intimidating and complex ...
SYS-CON Events announced today that Calligo, an innovative cloud service provider offering mid-sized companies the highest levels of data privacy and security, has been named "Bronze Sponsor" of SYS-CON's 21st International Cloud Expo ®, which will take place on Oct 31 - Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. Calligo offers unparalleled application performance guarantees, commercial flexibility and a personalised support service from its globally located cloud plat...
"We focus on SAP workloads because they are among the most powerful but somewhat challenging workloads out there to take into public cloud," explained Swen Conrad, CEO of Ocean9, Inc., in this SYS-CON.tv interview at 20th Cloud Expo, held June 6-8, 2017, at the Javits Center in New York City, NY.
"Outscale was founded in 2010, is based in France, is a strategic partner to Dassault Systémes and has done quite a bit of work with divisions of Dassault," explained Jackie Funk, Digital Marketing exec at Outscale, in this SYS-CON.tv interview at 20th Cloud Expo, held June 6-8, 2017, at the Javits Center in New York City, NY.
"I think DevOps is now a rambunctious teenager – it’s starting to get a mind of its own, wanting to get its own things but it still needs some adult supervision," explained Thomas Hooker, VP of marketing at CollabNet, in this SYS-CON.tv interview at DevOps Summit at 20th Cloud Expo, held June 6-8, 2017, at the Javits Center in New York City, NY.
"We are still a relatively small software house and we are focusing on certain industries like FinTech, med tech, energy and utilities. We help our customers with their digital transformation," noted Piotr Stawinski, Founder and CEO of EARP Integration, in this SYS-CON.tv interview at 20th Cloud Expo, held June 6-8, 2017, at the Javits Center in New York City, NY.
"We've been engaging with a lot of customers including Panasonic, we've been involved with Cisco and now we're working with the U.S. government - the Department of Homeland Security," explained Peter Jung, Chief Product Officer at Pulzze Systems, in this SYS-CON.tv interview at @ThingsExpo, held June 6-8, 2017, at the Javits Center in New York City, NY.
There is a huge demand for responsive, real-time mobile and web experiences, but current architectural patterns do not easily accommodate applications that respond to events in real time. Common solutions using message queues or HTTP long-polling quickly lead to resiliency, scalability and development velocity challenges. In his session at 21st Cloud Expo, Ryland Degnan, a Senior Software Engineer on the Netflix Edge Platform team, will discuss how by leveraging a reactive stream-based protocol,...
"We're here to tell the world about our cloud-scale infrastructure that we have at Juniper combined with the world-class security that we put into the cloud," explained Lisa Guess, VP of Systems Engineering at Juniper Networks, in this SYS-CON.tv interview at 20th Cloud Expo, held June 6-8, 2017, at the Javits Center in New York City, NY.