10 October 2017
Completion of patient enrolment in pivotal AEGIS-CKD Phase 3 study
Top line data anticipated early in the first quarter of 2018
London, UK, 10 October 2017: Shield Therapeutics plc (LSE:STX), a specialty pharmaceutical company focused on secondary care, today announces the completion of enrollment of the pivotal Phase 3 AEGIS-CKD study of its European-marketed product, Feraccru®. Top-line data, based on the 16-week primary endpoint, is anticipated early in the first quarter of 2018. Subjects were enrolled in 30 renal centres across the USA.
A positive outcome from this study will enable initiation of the regulatory filing with the US FDA that could lead to the commercialisation of Feraccru in the US and increase the target population for Feraccru from c. 330,000 Inflammatory Bowel Disease (IBD) patients with Iron Deficiency Anaemia (IDA) in Europe to c. 2.6m patients with IDA related to both IBD and CKD in Europe and the USA.
The study is evaluating Feraccru (ferric maltol, 30mg bd) compared to placebo in the treatment of IDA in patients with non-dialysis Chronic Kidney Disease (CKD). Feraccru is currently approved in Europe for the treatment of IDA in adults with IBD. Shield recently filed for approval of an expanded label for Feraccru in Europe.
“We are pleased to reach this important recruitment milestone. Many CKD patients struggle to tolerate currently available oral iron preparations, resulting in poor control of their IDA. We look forward to the data early in the first quarter of 2018 and to taking the next steps to make Feraccru available to as many patients as quickly as possible. I would like to thank the patients for their willingness to participate, as well as the clinicians and colleagues who have worked so diligently on this programme.”
Dr Mark SampsonChief Medical Officer of Shield Therapeutics
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Dr Mark Sampson, Chief Medical Officer
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About Shield Therapeutics plc
Shield Therapeutics is a specialty pharmaceutical company focused on the commercialisation and development of late-stage, hospital-focused pharmaceuticals which address areas of unmet medical need. 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 iron deficiency anaemia (IDA) in adult patients with inflammatory bowel disease (IBD) which has exclusive IP rights until the mid-2030’s. Shield Therapeutics, headquartered in London, is listed on LSE's AIM under the ticker STX. For more information please visit www.shieldtherapeutics.com.
Feraccru® is Shield's lead product and is a novel therapy for the treatment of IDA. Feraccru® received marketing authorisation across Europe in February 2016 for the treatment of IDA in adult patients with IBD and is in the early stages of commercialisation in European markets. The Group is currently completing a pivotal Phase 3 clinical trial of Feraccru® in IDA patients with pre-dialysis CKD and expects to announce results of this study early in the first quarter of 2018. A positive result is expected to facilitate the filing of an NDA for Feraccru® in the US as well as significantly broader commercialisation in Europe and beyond.