Navigation Links
Shield Therapeutics Files Investigational New Drug Application for ST10 for the Treatment of Iron Deficiency in Chronic Kidney Disease

LONDON, November 12, 2013 /PRNewswire/ --

Shield Therapeutics, an independent specialty pharmaceutical company focused on the development of mineral-derived hospital pharmaceuticals, today announces that it has filed an investigational new drug (IND) application with the US Food and Drug Administration (FDA) to initiate a Phase 3 pivotal study of ST10, its novel oral iron-replacement therapy, for the treatment of iron deficiency anaemia (IDA) in pre-dialysis patients with chronic kidney disease (CKD).  

ST10 is a novel oral ferric iron therapy being developed for the treatment of iron deficiency which has demonstrated potential as an effective oral alternative to parenteral (IV) iron in ferrous intolerant patients.  Previous clinical studies have shown that gastrointestinal absorption of ST10 is at least as good as ferrous products, however ST10 has minimal gastro-intestinal side effects so can be given on an empty stomach and is therefore given at a significantly lower daily dose.  As ST10 is not adversely affected by changes in gastric pH, it can also be co-prescribed with widely used acid-reducers.

The British National Formulary states: 'parenteral iron does not produce a faster response than oral iron provided the oral iron is taken reliably and is absorbed adequately.'  ST10 aims to deliver this compelling alternative to prescribers, patients and payors, in addition to avoiding the inconvenience, high cost and life-threatening hypersensitivity risks associated with IV infusions.

The 16-week prospective, multicentre, randomised, double-blind, placebo controlled AEGIS 3 study will enrol pre-dialysis CKD patients in the USA who have a diagnosis with iron deficiency anaemia.  ST10 is also currently being investigated in a pivotal Phase 3 study as a potential treatment for IDA in inflammatory bowel disease, top-line results from which are expected towards the end of 2013.

Epidemiology data suggests the current total IDA patient population in the EU, USA and Japan is approximately 34m, with an addressable population of 2.6m (IBD and CKD in the EU and US) in the first instance.  The core market in IDA is worth at least $3.0bn. The global CKD therapeutics market is forecast to grow at a compound annual growth rate (CAGR) of 6.4% to reach $11.6billion by 2018[1].

Carl Sterritt, Founder and Chief Executive Officer of Shield Therapeutics, stated: "We are excited about the market potential of ST10 and the filing of this IND application marks another important milestone in the development of ST10 as we move into a second major indication.  We believe the benefits ST10 will deliver to patients with CKD who cannot tolerate oral ferrous iron therapy, coupled with the convenient nature of its administration, will make ST10 a leader in the future treatment paradigm of IDA in CKD."

[1]Chronic Kidney Disease (CKD) Therapeutics - Pipeline Assessment and Market Forecasts to 2018, GlobalData, September 2011

About Shield Therapeutics

Shield Therapeutics (, 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 is currently conducting pivotal Phase 3 studies 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:

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

SOURCE Shield Therapeutics
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. Blue Cross Blue Shield of Michigan and Blue Care Network support the Drug Enforcement Administrations Nationwide Prescription "Drug Take-Back Day"
2. Wellness Center USA Inc. Signs Agreement to Acquire Psoria-Shield Inc.
3. Healthcare Expense Management Leader Patientco Receives $3.75M in funding led by BlueCross BlueShield Venture Partners and Sandbox Industries
4. Wellness Center USA, Inc. Completes Psoria-Shield Inc. Acquisition
5. Shield HealthCare Announces 12th Annual Caregiver Story Contest
6. BI-LO Offers Health Giveaways With Flu Vaccinations, Encourages Community To Shield Their Health This Flu Season
7. FDA Grants Soligenix Fast Track Designation for OrbeShield(TM) for the Reduction of Mortality Associated with Gastrointestinal Acute Radiation Syndrome (GI ARS)
8. Healthcare Fraud Shield Now Offers SIU Services
9. Radiation Detection, Monitoring & Safety Market (Geiger Counter, Ionization Chamber, Scintillator, Terahertz detector, Dosimeter, Environment Monitor, Shield, Lead Apron, Eyewear & Glove) - Competitive Analysis & Global Forecasts to 2017
10. Blue Cross Blue Shield Texas Launches "Be Covered Texas" Campaign to Raise Awareness of Individual Health Insurance Enrollment Options
11. ASSA ABLOY Door Group Announces RF Shielding Openings
Post Your Comments:
(Date:11/27/2015)... Research and Markets ( ) has announced the ... report to their offering. ... author the present scenario and growth prospects of the ... market size, the report considers revenue generated from the ... copper IUDs. The report forecasts the global intrauterine devices ...
(Date:11/26/2015)... , 26 november 2015 AAIPharma ... de geplande investering aan van ten minste ... laboratoria en het mondiale hoofdkantoor in ... zal resulteren in extra kantoorruimte en extra ... de groeiende behoeften van de farmaceutische en ...
(Date:11/26/2015)... Research and Markets ( ) has announced ... Outlook to 2019 - Rise in Cardiac Disorders and Growing ... to their offering. Boston ... scientific and others. --> The market ... Boston scientific and others. ...
Breaking Medicine Technology:
(Date:11/27/2015)... ... November 27, 2015 , ... CBD College ... Allied Health Education Programs (CAAHEP) awarded accreditation to its Diagnostic Medical Sonography program. CBD ... colleges, as only one of twelve colleges and universities in the state of California ...
(Date:11/27/2015)... ... 27, 2015 , ... Avid collector, Andrew Hawley from Vintage Rock Posters, announces ... This is one of Joplin's most famous and beautiful concert posters. The concert was ... in Ann Arbor. The According to Hawley, "It is hard to believe that Joplin's ...
(Date:11/26/2015)... ... November 26, 2015 , ... Inevitably when people think Thanksgiving, they also think ... during the Black Friday and Cyber Monday massage chair sales to receive ... high and low to find the best massage chair deals, they can see all ...
(Date:11/26/2015)... ... 2015 , ... The Catalent Applied Drug Delivery Institute today ... dose form selection in early phase drug development. The first of these is ... together the UK’s emerging life sciences companies, corporate partners, and investors, at Milton ...
(Date:11/26/2015)... ... November 26, 2015 , ... WorldCare International, Inc., the ... 61st annual Employee Benefits Conference. The Employee Benefits Conference was hosted by the ... Wednesday, November 11th, 2015. The conference was held at the Hawaii Convention Center ...
Breaking Medicine News(10 mins):