Shield Therapeutics plc
("Shield" or the "Company")
Update on the AEGIS-CKD study
London, UK, 16 March 2018: Shield Therapeutics plc (LSE:STX), a commercial stage, pharmaceutical company with an initial focus on addressing iron deficiency, announces an update following detailed analyses of the data from the double-blind period of the AEGIS-CKD study, which it has presented to the FDA in a previously scheduled pre-NDA meeting.
Following a review of all enrolled subjects who completed the initial 16-week placebo-controlled portion of the study, a small number of patients in both treatment arms were identified as experiencing pre-specified events that could have led to withdrawal but, as permitted in the study protocol, with Investigator discretion they remained in the study. The Company believes the inclusion, post the confounding events, of data from these patients could have significantly impacted the haematology-focused primary endpoint of the pivotal study. Consequently, further analyses of the data have been conducted using an amended statistical analysis plan that removed the confounding data.
As a result of these revised analyses, patients treated with Feraccru demonstrated a statistically significant response (p=0.0149) in haemoglobin levels after 16 weeks of treatment compared to placebo (difference 0.52g/dl (CI 0.102, 0.930) and statistically significant results were achieved across a range of secondary iron parameters (TSAT, Ferritin levels, serum iron levels). Whilst the Company believes there is a clear and robust rationale for the analyses of the dataset as outlined, there can be no certainty that the FDA will accept the approach taken. Details of the outcome of the discussion with the FDA are therefore uncertain and clarity on such matters will be communicated to the market as soon as it is available.
Carl Sterritt, Chief Executive Officer of Shield Therapeutics, said: "I am reassured that we have rapidly been able to understand what we believe occurred in the study to produce the initial topline result. This has enabled us to take appropriate and well-controlled steps to prepare a data package that underpinned a constructive pre-NDA meeting with the FDA. The outcome of the FDA's deliberations on our submissions will help inform the Group's ongoing strategic review, which it intends to update shareholders on as soon as possible. In the meantime further routine analysis of the dataset will continue to deepen our understanding of the effect of Feraccru on IDA in CKD patients.
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For further information please contact:
Shield Therapeutics plc +44 (0)207 186 8500
Carl Sterritt, Chief Executive Officer
Dr Karl Keegan, Chief Financial Officer
Fleur Wood, Director, Investor Relations
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
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 Carl Sterritt, Chief Executive 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 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 Company 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 Company'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 Company'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 Company disclaims any obligation to update any forward-looking statements contained in this release, even if subsequent events cause our views to change.
