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 top-line results from pivotal Phase III study of Feraccru® (Ferric Maltol) in the treatment of IDA in patients with CKD

- Primary efficacy endpoint not achieved

- Tolerability profile of Feraccru reconfirmed

- A review of the full dataset will be conducted to better understand the result

- Feraccru remains commercially available for IBD patients with IDA through Shield and its commercial partners in Europe and other ongoing clinical studies will continue

London, UK, 5 February 2018: Shield Therapeutics plc (LSE:STX), a commercial stage, pharmaceutical company delivering innovative specialty pharmaceuticals to address patients' unmet medical needs, with an initial focus on addressing anaemia associated with renal and gastrointestinal disorders, today announces top-line results from its AEGIS-CKD pivotal Phase III study of Feraccru. Feraccru is a novel oral ferric iron therapy that has been approved and marketed in Europe since 2016 for the treatment of iron deficiency anemia (IDA), initially in patients with inflammatory bowel disease (IBD).

The Feraccru AEGIS-CKD study is a pivotal Phase III trial with a primary endpoint evaluating haemoglobin response to Feraccru (ferric maltol, 30mg twice daily) compared to placebo in the treatment of IDA in patients with chronic kidney disease (CKD). Top-line data is based on the 16-week primary endpoint, with 168 subjects enrolled in 30 renal centres across the US.

Initial clinical trial results:

Feraccru failed to meet the study's primary endpoint of demonstrating a statistical difference in change of haemoglobin from baseline compared to placebo at 16 weeks (0.45 v 0.15 g/dL, p=0.1686).

The response at 8 weeks demonstrated separation of the treatment arms (0.53 v 0.0 g/dL), which was not sustained to week 16.

Patient drop-out rate was low over 16 weeks and similar in both arms - 10 (9%) in the Feraccru arm v 7 (12.5%) placebo, reconfirming the strong tolerability profile of Feraccru.

Carl Sterritt, Chief Executive Officer of Shield Therapeutics, said: "We are surprised and disappointed by these top-line findings. Feraccru has previously demonstrated positive efficacy and safety in IBD patients, which led to it being approved in Europe where it continues to gain commercial traction. We now await the full dataset in order to fully understand the study's outcome and define the next steps in our strategy. Concurrently, we will focus on interacting with EMA on the label expansion application, on concluding the AEGIS-H2H study as expeditiously as possible and on taking actions to extend the current cash runway beyond the end of Q2 2018."

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.

Feraccru in Europe - possible extension of commercial label

In September 2017, Shield submitted an application to the European Medicines Agency, to broaden the existing commercial label for Feraccru to include the treatment of all patients with IDA, which has the potential to significantly expand the market opportunity for Feraccru in Europe. We continue to expect a final decision from the EMA on this application during the first half of 2018.

Strategy and next steps

Shield will continue to analyse the preliminary data findings from the AEGIS-CKD pivotal Phase III study and will conduct a review of the study's full dataset as soon as it is available, to understand the detailed results and assess whether any other confounding factors affected the outcome. In parallel, Feraccru will continue to be available commercially through Shield and our European partners for IBD patients with IDA. The Group will seek to provide a further update when it announces its financial results for the year ended 31 December 2017.

- Ends -

For further information please contact:

Shield Therapeutics plc +44 (0)207 186 8500

Carl Sterritt, Chief Executive Officer

Dr Karl Keegan, 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

US Investor Relations +1 (212) 867 1762

Lazar Partners

Fern Lazar/David Carey

This announcement contains inside information for the purposes of Article 7 of Regulation 596/2014. The person who arranged for the release of this announcement on behalf of Shield was Dr Mark Sampson, Chief Medical Officer

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 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 IDA in adult patients with IBD 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.