Data from real-world clinical use of Feraccru

RNS Number : 8305S

Shield Therapeutics PLC

28 June 2018

 

Shield Therapeutics plc

("Shield" or the "Group")

Shield reports recently presented supportive data from

real-world clinical use of Feraccru® (Ferric Maltol)

London, UK, 28 June 2018: Shield Therapeutics plc (LSE:STX), a commercial stage, pharmaceutical company delivering innovative specialty pharmaceuticals to address patients' unmet medical needs, today reports on recent presentations of results from two studies of the use of Feraccru in clinical practice.  The FRESH study (Feraccru® Real World Effectiveness Study in Hospital Practice) was presented at the British Society of Gastroenterology in Liverpool and data from a health economic study has been presented at the recent European Haematology Association meeting in Stockholm.  Feraccru is a novel oral ferric iron therapy that is approved and marketed in Europe for the treatment of iron deficiency (ID).

Controlled clinical studies can overestimate the effectiveness of new medicines and under report tolerability issues due to the willingness of subjects to remain on study despite adverse events.  This has been shown to be common for oral iron preparations, where real life data often demonstrates poorer compliance than seen in studies. 

The FRESH study was conducted across seven UK hospitals and is the first published evaluation of the use of Feraccru in clinical practice; whilst researchers at the London North West University Healthcare NHS Trust reported on the potential health economic benefit of using Feraccru in patients who would otherwise have been considered for IV iron therapy.

Preliminary results:

The FRESH study reported that, in inflammatory bowel disease (IBD) patients with recorded haemoglobin (Hb) measurements at 12 weeks, 62% had normalised Hb (≥12.0 g/dL for females and ≥13.0 g/dL for males).  Dr Fraser Cummings, consultant gastroenterologist at Southampton General Hospital, commented "Importantly, this result is comparable to that of the AEGIS phase III study (66% of patients with normalised Hb by 12 weeks) and supports the clinical effectiveness of Feraccru in real world clinical practice."

Dr Silvia Lovato, Honorary Senior Clinical Lecturer, London North West University Healthcare NHS Trust said, "We audited the first 28 patients who were prescribed ferric maltol and savings over 12 months were found to amount to £11,940 and 5 fewer days of nursing time compared to using IV iron.  If we apply the same considerations to all 800 patients who received parenteral iron infusion in the Trust in the previous 12 months, the estimated savings with ferric maltol would have been £257,604 and 107.7 days of nurse time."

About Feraccru®

Feraccru is a novel, stable, non-salt, oral formulation of ferric iron, which has a differentiated mechanism of action compared to salt-based oral iron therapies. When salt-based oral iron therapies are ingested, the iron must dissociate from the salt in the GI tract to allow the iron to be absorbed and treat the IDA.  This free iron readily chelates to form insoluble clumps and produces damaging free radicals that together cause a range of mild-to-severe GI adverse events, including nausea, bloating and constipation, leading to poor tolerability, reduced patient compliance and ultimately treatment failure.  In addition, many patients with IDA are concurrently treated with medicines that raise the pH in the gut which further reduces the effect of salt-based oral iron therapies as they require highly acidic conditions to be absorbed.

Feraccru is not an iron salt, and iron can be absorbed from the ferric maltol molecule, as a result, it does not routinely cause the same treatment-limiting intolerance issues. Feraccru has been shown in clinical trials to be well-tolerated by patients even when they had previously failed treatment with salt-based oral iron therapies, which should lead to increased patient compliance and better patient outcomes.

Currently, the only treatment option for IDA patients who cannot tolerate salt-based oral iron therapies, is IV iron therapy. IV iron therapies quickly increase iron stores via direct administration of very large doses of iron, causing an increase in Hb levels that is physiologically controlled and occurs over a period of weeks, as is the case with Feraccru.  IV iron therapies, however, are invasive, costly, inconvenient and complex to administer, and also come with potentially life-threatening, spontaneous hypersensitivity reactions. 

About Iron Deficiency

The WHO state that iron deficiency is the most common and widespread nutritional disorder in the world.   As well as affecting a large number of children and women in non-industrialized countries, it is the only nutrient deficiency which is also significantly prevalent in virtually all industrialized nations.  There are no current global figures for iron deficiency, but using anaemia as an indirect indicator it can be estimated that most preschool children and pregnant women in non-industrialized countries, and at least 30-40% in industrialized countries, are iron deficient.

Other Feraccru pipeline events:

Feraccru AEGIS-H2H non-inferiority EU Phase 3b study

The AEGIS-H2H Phase 3b study is designed as a non-inferiority trial comparing the efficacy and safety of Feraccru to the market-leading latest generation form of IV iron (Ferinject/Injectafer, ferric carboxymaltose).  Primary endpoint data from the AEGIS-H2H study is expected to be available in the second half of 2018.  

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For further information please contact:

Shield Therapeutics plc                                                                                                 [phone]

Carl Sterritt, Chief Executive Officer

Dr Karl Keegan, Chief Financial Officer

Nominated Advisor and Joint Broker                                                                         [phone]

Liberum Capital Limited

Christopher Britton/Steve Pearce

Joint Broker                                                                                                                     [phone]

Peel Hunt LLP

James Steel/ Dr Christopher Golden

Financial PR Advisor                                                                                                      [phone]

Consilium Strategic Communications

Mary-Jane Elliott/Matthew Neal

About Shield Therapeutics plc

Shield Therapeutics is a commercial stage pharmaceutical company, delivering innovative specialty pharmaceuticals to address patients' unmet medical needs.  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®, for the treatment of all adults with iron deficiency with or without anaemia which has exclusive IP rights until the mid-2030's.  For more information please visit www.shieldtherapeutics.com.

Forward-Looking Statements

This press release contains forward-looking statements. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements.  These forward-looking statements are based on management's current expectations and include statements related to the timing of future results of Feraccru trials and the timing and success of the Group's regulatory plans and commercial strategy for Feraccru.  These statements are neither promises nor guarantees, but involve known and unknown risks and uncertainties, many of which are beyond our control, that may cause actual results, performance or achievements to be materially different from management's expectations expressed or implied by the forward-looking statements, including, but not limited to, risks associated with the regulatory approval process, the Group's business and results of operations, competition and other market factors.  The forward-looking statements made in this press release represent management's expectations as of the date of this press release, and except as required by law, the Group disclaims any obligation to update any forward-looking statements contained in this release, even if subsequent events cause our views to change.

 

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