Shield Thera Regulatory News (STX)

This announcement contains inside information for the purposes of Article 7 of Regulation 596/2014.

Shield Therapeutics plc

("Shield" or the "Group")

Shield reports completion of recruitment to AEGIS Head to Head Study (AEGIS-H2H) comparing Feraccru with ferric carboxymaltose

London, UK, 13 Sept 2018: Shield Therapeutics plc (LSE:STX), a commercial stage, pharmaceutical company delivering innovative specialty pharmaceuticals to address patients' unmet medical needs, today announces completion of recruitment of the AEGIS-H2H Phase 3b study of oral Feraccru compared to Intravenous (IV) ferric carboxymaltose in subjects with inflammatory bowel disease (IBD) and iron deficiency anaemia (IDA). Feraccru is a novel oral ferric iron therapy that has been approved and marketed in Europe for the treatment of iron deficiency (ID) in adults.

The Feraccru AEGIS-H2H study is a Phase 3b trial comparing the change in haemoglobin (Hb) from baseline at 12 weeks after oral Feraccru 30mg twice daily for 12 weeks versus IV ferric carboxymaltose dosed in line with its commercially approved dosing regimen. The primary endpoint is non-inferiority of Hb response at 12 weeks with preliminary results anticipated in Q1 2019.

Dr Mark Sampson, Chief Medical Officer of Shield, said, "The treatment of people living with IBD who develop IDA has increasingly been focused on intermittent IV infusions of iron due to intolerance or lack of efficacy of oral iron salts. The completion of recruitment into this study is an important step in confirming the potential of Feraccru to be an alternative to IV iron in these patients."

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 gastrointestinal tract (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, and 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.

Feraccru® has been approved by the European Commission for the treatment of iron deficiency in adults, with or without anaemia.

About Iron Deficiency

The WHO state that ID 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.

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For further information please contact:

Shield Therapeutics plc +44 (0)207 186 8500

Carl Sterritt, Chief Executive Officer

Tim Watts, Chief Financial Officer

Nominated Advisor and Joint Broker +44 (0)203 100 2222

Liberum Capital Limited

Christopher Britton/Steve Pearce

Joint Broker +44 (0)207 418 8900

Peel Hunt LLP

James Steel/Dr Christopher Golden

Financial PR Advisor +44 (0)203 709 5700

Consilium Strategic Communications

Mary-Jane Elliott/Matthew Neal

Notes

The person who arranged for the release of this announcement on behalf of Shield was Dr Mark Sampson, Chief Medical Officer

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®, for the treatment of ID in adults 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.