Shield Therapeutics PLC Positive top-line results from AEGIS-PAED PK study (3392R)

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RNS Number : 3392R

Shield Therapeutics PLC

14 June 2018

Shield Therapeutics plc

("Shield" or the "Group")

Shield reports positive top-line results from its AEGIS-PAED PK Paediatric Phase I Pharmacokinetics study of Feraccru(R) (Ferric Maltol) in subjects with iron deficiency

London, UK, 14 June 2018: Shield Therapeutics plc (LSE:STX), a commercial stage, pharmaceutical company delivering innovative specialty pharmaceuticals to address patients' unmet medical needs, today announces top line results from its paediatric phase I pharmacokinetics (PK) study of Feraccru in 36 subjects aged 12-17 years. Feraccru is a novel oral ferric iron therapy that is approved and marketed in Europe for the treatment of iron deficiency (ID).

The Feraccru AEGIS-PAED PK study is a Phase I trial with a primary endpoint of evaluating the iron response to, and safety of, Feraccru at different doses in adolescent subjects aged 12 -17 years with ID. Completion of this study signifies delivery of the first major milestone in Feraccru's paediatric development plan as agreed with the EMA. These data allow for selection of an optimal dosing schedule for a Phase III pivotal study in children that will follow subject to funding.

Positive results from the Phase III study should lead to Feraccru being granted a paediatric license, thus providing an even larger commercial opportunity for this effective therapy in the treatment of ID.

Preliminary results:

Feraccru achieved all the pre-defined goals of the protocol, including demonstrating positive effects on serum iron parameters over the duration of the study and showing good tolerance at all dosing levels.

Dr Stephen Allan, Professor of Paediatrics, Liverpool School of Tropical Medicine, UK commented, : "Iron deficiency is a global problem in children that significantly impacts their health and education and leads to longer term societal impact. There is a great need for a widely available oral therapy that is both effective and well tolerated. These results are encouraging and I look forward to the results of the Phase III study."

Mark Sampson, Chief Medical Officer at Shield Therapeutics stated "I am delighted that these results confirm the potential of Feraccru to provide a well-tolerated and effective oral therapy for children suffering with iron deficiency and allows us to progress to our pivotal Phase III programme. We are grateful to the children and parents who were willing to participate in the study and progress our knowledge of Feraccru."

About Feraccru(R)

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 ID. 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 ID 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 ID patients who cannot tolerate salt-based oral iron therapies, is IV iron therapy. IV iron therapies quickly increase iron stores via direct administration of high 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

US Investor Relations [phone]

Lazar Partners

Fern Lazar/David Carey

About Shield Therapeutics plc

Shield 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(R), for the treatment of ID in adult patients 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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June 14, 2018 02:00 ET (06:00 GMT)