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
Many private cloud projects were built to deliver self-service access to development and test resources. While those clouds delivered faster access to resources, they lacked visibility, control and security needed for production deployments. In their session at 18th Cloud Expo, Steve Anderson, Product Manager at BMC Software, and Rick Lefort, Principal Technical Marketing Consultant at BMC Software, will discuss how a cloud designed for production operations not only helps accelerate developer...
trust and privacy in their ecosystem. Assurance and protection of device identity, secure data encryption and authentication are the key security challenges organizations are trying to address when integrating IoT devices. This holds true for IoT applications in a wide range of industries, for example, healthcare, consumer devices, and manufacturing. In his session at @ThingsExpo, Lancen LaChance, vice president of product management, IoT solutions at GlobalSign, will teach IoT developers how t...
The IETF draft standard for M2M certificates is a security solution specifically designed for the demanding needs of IoT/M2M applications. In his session at @ThingsExpo, Brian Romansky, VP of Strategic Technology at TrustPoint Innovation, will explain how M2M certificates can efficiently enable confidentiality, integrity, and authenticity on highly constrained devices.
Manufacturers are embracing the Industrial Internet the same way consumers are leveraging Fitbits – to improve overall health and wellness. Both can provide consistent measurement, visibility, and suggest performance improvements customized to help reach goals. Fitbit users can view real-time data and make adjustments to increase their activity. In his session at @ThingsExpo, Mark Bernardo Professional Services Leader, Americas, at GE Digital, will discuss how leveraging the Industrial Interne...
There is an ever-growing explosion of new devices that are connected to the Internet using “cloud” solutions. This rapid growth is creating a massive new demand for efficient access to data. And it’s not just about connecting to that data anymore. This new demand is bringing new issues and challenges and it is important for companies to scale for the coming growth. And with that scaling comes the need for greater security, gathering and data analysis, storage, connectivity and, of course, the...
The IoTs will challenge the status quo of how IT and development organizations operate. Or will it? Certainly the fog layer of IoT requires special insights about data ontology, security and transactional integrity. But the developmental challenges are the same: People, Process and Platform. In his session at @ThingsExpo, Craig Sproule, CEO of Metavine, will demonstrate how to move beyond today's coding paradigm and share the must-have mindsets for removing complexity from the development proc...
Redis is not only the fastest database, but it has become the most popular among the new wave of applications running in containers. Redis speeds up just about every data interaction between your users or operational systems. In his session at 18th Cloud Expo, Dave Nielsen, Developer Relations at Redis Labs, will shares the functions and data structures used to solve everyday use cases that are driving Redis' popularity.
Much of the value of DevOps comes from a (renewed) focus on measurement, sharing, and continuous feedback loops. In increasingly complex DevOps workflows and environments, and especially in larger, regulated, or more crystallized organizations, these core concepts become even more critical. In his session at @DevOpsSummit at 18th Cloud Expo, Andi Mann, Chief Technology Advocate at Splunk, will show how, by focusing on 'metrics that matter,' you can provide objective, transparent, and meaningfu...
Artificial Intelligence has the potential to massively disrupt IoT. In his session at 18th Cloud Expo, AJ Abdallat, CEO of Beyond AI, will discuss what the five main drivers are in Artificial Intelligence that could shape the future of the Internet of Things. AJ Abdallat is CEO of Beyond AI. He has over 20 years of management experience in the fields of artificial intelligence, sensors, instruments, devices and software for telecommunications, life sciences, environmental monitoring, process...
Increasing IoT connectivity is forcing enterprises to find elegant solutions to organize and visualize all incoming data from these connected devices with re-configurable dashboard widgets to effectively allow rapid decision-making for everything from immediate actions in tactical situations to strategic analysis and reporting. In his session at 18th Cloud Expo, Shikhir Singh, Senior Developer Relations Manager at Sencha, will discuss how to create HTML5 dashboards that interact with IoT devic...
We're entering the post-smartphone era, where wearable gadgets from watches and fitness bands to glasses and health aids will power the next technological revolution. With mass adoption of wearable devices comes a new data ecosystem that must be protected. Wearables open new pathways that facilitate the tracking, sharing and storing of consumers’ personal health, location and daily activity data. Consumers have some idea of the data these devices capture, but most don’t realize how revealing and...
Struggling to keep up with increasing application demand? Learn how Platform as a Service (PaaS) can streamline application development processes and make resource management easy.
SYS-CON Events announced today that Ericsson has been named “Gold Sponsor” of SYS-CON's @ThingsExpo, which will take place on June 7-9, 2016, at the Javits Center in New York, New York. Ericsson is a world leader in the rapidly changing environment of communications technology – providing equipment, software and services to enable transformation through mobility. Some 40 percent of global mobile traffic runs through networks we have supplied. More than 1 billion subscribers around the world re...
In the world of DevOps there are ‘known good practices’ – aka ‘patterns’ – and ‘known bad practices’ – aka ‘anti-patterns.' Many of these patterns and anti-patterns have been developed from real world experience, especially by the early adopters of DevOps theory; but many are more feasible in theory than in practice, especially for more recent entrants to the DevOps scene. In this power panel at @DevOpsSummit at 18th Cloud Expo, moderated by DevOps Conference Chair Andi Mann, panelists will dis...
We’ve worked with dozens of early adopters across numerous industries and will debunk common misperceptions, which starts with understanding that many of the connected products we’ll use over the next 5 years are already products, they’re just not yet connected. With an IoT product, time-in-market provides much more essential feedback than ever before. Innovation comes from what you do with the data that the connected product provides in order to enhance the customer experience and optimize busi...