Shield Therapeutics Announces The Acceptance For Review By The European Medicines Agency Of The Marketing Authorisation Application For Feraccru®
LONDON, January 7, 2015 /PRNewswire/ --
~ Shield seeks approval of Feraccru for the treatment of iron deficiency anaemia ~
Shield Therapeutics (Shield), an independent pharmaceutical company focused on the development of specialist hospital pharmaceuticals, today announces the recent acceptance for review by the European Medicines Agency (EMA) of the Marketing Authorisation Application (MAA) for Feraccru (ST10, ferric maltol). Shield is seeking marketing authorisation of Feraccru for the treatment of iron deficiency anaemia (IDA), initially in patients with inflammatory bowel disease (IBD) and those intolerant of oral ferrous therapies, thereby providing an effective alternative to those patients whose only current option is intravenous iron therapy.
The MAA for Feraccru, a novel orally-delivered form of ferric iron, is based on the highly positive findings of the AEGIS pivotal Phase III programme. Data from this study showed that Feraccru delivered a mean increase in haemoglobin levels of 2.3g/dL in 12 weeks, clearly meeting the primary endpoint of haemoglobin change compared to placebo (p<0.0001). Feraccru also rapidly delivered significant haemoglobin increases after only 4 weeks of therapy (1.1g/dL, p<0.0001) and more than 65% of treated subjects experienced normalised haemoglobin levels by week 12.
These results strongly demonstrated Feraccru's potential to be the only realistic oral treatment for ferrous intolerant IDA patients, thereby providing an effective alternative therapy to i.v. iron, which comes with the risk of serious and life-threatening hypersensitivity reactions. Leading regulatory agencies such as the EMA specify[1] that i.v. irons only be administered when full resuscitation facilities can be assured, suitably trained staff are immediately available and patients are closely observed following each injection. Together these requirements significantly complicate administration of such therapies.
The EMA will review the application under the centralised marketing authorisation procedure. When approved Feraccru will receive marketing authorisation in all member states of the European Union (EU), as well as in Iceland, Liechtenstein and Norway.
Feraccru is also being studied for the treatment of IDA in pre-dialysis chronic kidney disease patients and the data generated from this study will, along with the data generated from the pivotal studies in IBD patients, be used to form part of a subsequent New Drug Application submission to the FDA in the USA.
Effectiveness data on Feraccru were presented in 2014 at ECCO and UEGW, will soon be published in a leading peer-reviewed journal and will be further presented at the ECCO meeting in February 2015.
-------------------------------------------------- 1. http://www.ema.europa.eu/docs/en_GB/document_library/Referrals_document/IV_iron_31/WC500151308.pdf Commenting on the results, Professor Christoph Gasche, Professor of Medicine, Medical University of Vienna, Austria, the Principal Investigator on the AEGIS Phase III Programme, said:
"The results of the AEGIS study confirm our belief that Feraccru has real potential to become a leading treatment of iron deficiency anaemia. Not only did the results show a significant increase in haemoglobin levels, but it was also very well tolerated in our patients. Once approved we would expect Feraccru to provide a simple and effective alternative to intravenous iron for our patients."
Shield's Founder and Chief Executive Officer, Carl Sterritt, commented:
"Granting a centralised data review was an early recognition of the multiple patient benefits that Feraccru is likely to deliver and I am delighted the European Medicines Agency has now accepted for review Feraccru's marketing authorisation application. This is a major milestone for the Company and we are pleased to continue to progress our first novel therapy, the approval of which should provide patients, prescribers and payors with a novel therapeutic alternative without the risks, inconveniences, unnecessary expense and side effects associated with the current standards of care. We look forward to 2015, during which we will work closely with the EMA as it reviews the data and commence commercial preparations so we can bring Feraccru to patients as soon as possible."
About Feraccru
Feraccru contains iron in a stable ferric state as a complex with a trimaltol ligand (ferric maltol). It is formulated as 30mg of ferric iron in a hard gelatin capsule. The complex is designed to provide iron for uptake across the intestinal wall and transfer to the iron transport and storage proteins in the body. Feraccru dissociates on uptake from the gastro-intestinal tract and ferric maltol itself does not appear to enter the systemic circulation.
Clinical Efficacy
The safety and efficacy of Feraccru for the treatment of iron deficiency anaemia in 128 adult patients with IBD (Ulcerative Colitis and Crohn's disease) and recorded intolerance of ferrous sulphate, was assessed in randomised, placebo-controlled clinical studies (AEGIS 1 and AEGIS 2). Subjects were randomised to receive either 30mg Feraccru twice a day, or a matched placebo capsule for 12 weeks. The primary efficacy analysis was the rise in Hb levels from baseline to week 12 compared to placebo. Mean Hb levels increased by 2.26g/dL in Feraccru-treated subjects from baseline (mean Hb 11.10 g/dL [SD 1.03]) to Week 12 (mean Hb 13.20 g/dL [SD 1.04]) compared to no change in placebo treated subjects from baselines (mean Hb 11.10 g/dL [SD 0.85]) to week 12 (mean Hb 11.15 g/dL [SD 1.04)]. The difference between the change from baseline for Feraccru compared to placebo at week 12 was 2.25 g/dL (p<0.0001).
Clinical Safety
In clinical trials involving 128 IBD patients, 109 of whom were treated for up to 64 weeks with Feraccru capsules, adverse reactions were seen in 23% of subjects (N=109). The most frequently reported adverse reactions were gastrointestinal symptoms (abdominal pain, flatulence constipation and diarrhoea). In the 12-week placebo-controlled portion of the studies, adverse reactions were reported in 25% of subjects (N= 64) treated with Feraccru 30mg twice a day compared to 12% of subjects (N=64) receiving placebo. Feraccru should not be used in patients with known hypersensitivity to ferric maltol or to any of the excipients of the product.
Members of Shield's management team will be attending the upcoming JP Morgan Healthcare Conference in San Francisco from the 12th to 14th of January.
About Shield Therapeutics
Shield Therapeutics (http://www.shieldtx.com) 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, Feraccru, for the treatment of IDA associated with inflammatory bowel disease and is soon to commence a Phase 3 study of Feraccru for the treatment of IDA in patients with chronic kidney disease. Shield Therapeutics is also developing a novel iron-based phosphate binder, PT20, for the treatment of hyperphosphataemia related to dialysis-dependent or dialysis-independent chronic kidney disease. PT20 is currently completing a first pivotal trial.
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 / Lindsey Neville
Tel +44(0)203-709-5700
Email: shieldtherapeutics@consilium-comms.com
Help employers find you! Check out all the jobs and post your resume.
~ Shield seeks approval of Feraccru for the treatment of iron deficiency anaemia ~
Shield Therapeutics (Shield), an independent pharmaceutical company focused on the development of specialist hospital pharmaceuticals, today announces the recent acceptance for review by the European Medicines Agency (EMA) of the Marketing Authorisation Application (MAA) for Feraccru (ST10, ferric maltol). Shield is seeking marketing authorisation of Feraccru for the treatment of iron deficiency anaemia (IDA), initially in patients with inflammatory bowel disease (IBD) and those intolerant of oral ferrous therapies, thereby providing an effective alternative to those patients whose only current option is intravenous iron therapy.
The MAA for Feraccru, a novel orally-delivered form of ferric iron, is based on the highly positive findings of the AEGIS pivotal Phase III programme. Data from this study showed that Feraccru delivered a mean increase in haemoglobin levels of 2.3g/dL in 12 weeks, clearly meeting the primary endpoint of haemoglobin change compared to placebo (p<0.0001). Feraccru also rapidly delivered significant haemoglobin increases after only 4 weeks of therapy (1.1g/dL, p<0.0001) and more than 65% of treated subjects experienced normalised haemoglobin levels by week 12.
These results strongly demonstrated Feraccru's potential to be the only realistic oral treatment for ferrous intolerant IDA patients, thereby providing an effective alternative therapy to i.v. iron, which comes with the risk of serious and life-threatening hypersensitivity reactions. Leading regulatory agencies such as the EMA specify[1] that i.v. irons only be administered when full resuscitation facilities can be assured, suitably trained staff are immediately available and patients are closely observed following each injection. Together these requirements significantly complicate administration of such therapies.
The EMA will review the application under the centralised marketing authorisation procedure. When approved Feraccru will receive marketing authorisation in all member states of the European Union (EU), as well as in Iceland, Liechtenstein and Norway.
Feraccru is also being studied for the treatment of IDA in pre-dialysis chronic kidney disease patients and the data generated from this study will, along with the data generated from the pivotal studies in IBD patients, be used to form part of a subsequent New Drug Application submission to the FDA in the USA.
Effectiveness data on Feraccru were presented in 2014 at ECCO and UEGW, will soon be published in a leading peer-reviewed journal and will be further presented at the ECCO meeting in February 2015.
-------------------------------------------------- 1. http://www.ema.europa.eu/docs/en_GB/document_library/Referrals_document/IV_iron_31/WC500151308.pdf Commenting on the results, Professor Christoph Gasche, Professor of Medicine, Medical University of Vienna, Austria, the Principal Investigator on the AEGIS Phase III Programme, said:
"The results of the AEGIS study confirm our belief that Feraccru has real potential to become a leading treatment of iron deficiency anaemia. Not only did the results show a significant increase in haemoglobin levels, but it was also very well tolerated in our patients. Once approved we would expect Feraccru to provide a simple and effective alternative to intravenous iron for our patients."
Shield's Founder and Chief Executive Officer, Carl Sterritt, commented:
"Granting a centralised data review was an early recognition of the multiple patient benefits that Feraccru is likely to deliver and I am delighted the European Medicines Agency has now accepted for review Feraccru's marketing authorisation application. This is a major milestone for the Company and we are pleased to continue to progress our first novel therapy, the approval of which should provide patients, prescribers and payors with a novel therapeutic alternative without the risks, inconveniences, unnecessary expense and side effects associated with the current standards of care. We look forward to 2015, during which we will work closely with the EMA as it reviews the data and commence commercial preparations so we can bring Feraccru to patients as soon as possible."
About Feraccru
Feraccru contains iron in a stable ferric state as a complex with a trimaltol ligand (ferric maltol). It is formulated as 30mg of ferric iron in a hard gelatin capsule. The complex is designed to provide iron for uptake across the intestinal wall and transfer to the iron transport and storage proteins in the body. Feraccru dissociates on uptake from the gastro-intestinal tract and ferric maltol itself does not appear to enter the systemic circulation.
Clinical Efficacy
The safety and efficacy of Feraccru for the treatment of iron deficiency anaemia in 128 adult patients with IBD (Ulcerative Colitis and Crohn's disease) and recorded intolerance of ferrous sulphate, was assessed in randomised, placebo-controlled clinical studies (AEGIS 1 and AEGIS 2). Subjects were randomised to receive either 30mg Feraccru twice a day, or a matched placebo capsule for 12 weeks. The primary efficacy analysis was the rise in Hb levels from baseline to week 12 compared to placebo. Mean Hb levels increased by 2.26g/dL in Feraccru-treated subjects from baseline (mean Hb 11.10 g/dL [SD 1.03]) to Week 12 (mean Hb 13.20 g/dL [SD 1.04]) compared to no change in placebo treated subjects from baselines (mean Hb 11.10 g/dL [SD 0.85]) to week 12 (mean Hb 11.15 g/dL [SD 1.04)]. The difference between the change from baseline for Feraccru compared to placebo at week 12 was 2.25 g/dL (p<0.0001).
Clinical Safety
In clinical trials involving 128 IBD patients, 109 of whom were treated for up to 64 weeks with Feraccru capsules, adverse reactions were seen in 23% of subjects (N=109). The most frequently reported adverse reactions were gastrointestinal symptoms (abdominal pain, flatulence constipation and diarrhoea). In the 12-week placebo-controlled portion of the studies, adverse reactions were reported in 25% of subjects (N= 64) treated with Feraccru 30mg twice a day compared to 12% of subjects (N=64) receiving placebo. Feraccru should not be used in patients with known hypersensitivity to ferric maltol or to any of the excipients of the product.
Members of Shield's management team will be attending the upcoming JP Morgan Healthcare Conference in San Francisco from the 12th to 14th of January.
About Shield Therapeutics
Shield Therapeutics (http://www.shieldtx.com) 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, Feraccru, for the treatment of IDA associated with inflammatory bowel disease and is soon to commence a Phase 3 study of Feraccru for the treatment of IDA in patients with chronic kidney disease. Shield Therapeutics is also developing a novel iron-based phosphate binder, PT20, for the treatment of hyperphosphataemia related to dialysis-dependent or dialysis-independent chronic kidney disease. PT20 is currently completing a first pivotal trial.
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 / Lindsey Neville
Tel +44(0)203-709-5700
Email: shieldtherapeutics@consilium-comms.com
Help employers find you! Check out all the jobs and post your resume.