Feraccru®/Accrufer® publications

Shield Therapeutics plc

("Shield" or the "Group" or the "Company")

Feraccru®/Accrufer^® publications

London, UK, 3 June 2020: Shield Therapeutics plc (LSE: STX), a commercial stage, pharmaceutical company with a focus on addressing iron deficiency with its lead product Feraccru®/Accrufer^® (ferric maltol), notes the recent publication of two papers concerning Feraccru®/Accrufer^®.

ORal IrON supplementation with ferric maltol in patients with Pulmonary Hypertension (ORION-PH)

The European Respiratory Journal has recently published the results of ORION-PH (European Respiratory Journal; DOI: 10.1183/13993003.00616-2020; Olsson KM, Fuge J, Brod T, et al).  Iron deficiency is common in people with pulmonary hypertension (PH) and contributes to reduced physical performance. Whilst current guidelines recommend the use of intravenous (IV) iron this exploratory open label study aimed to explore the use of ferric maltol in PH patients. The primary objective of the study was the change in haemoglobin levels from baseline to week 12 following treatment with ferric maltol. Secondary objectives included the effects of oral ferric maltol on iron status, World Health Organization Functional Class (WHO FC) and 6 min walking distance (6MWD).

The study concluded that ferric maltol was well tolerated by the majority of patients and resulted in significant improvements in iron status and haemoglobin levels after 12 weeks of treatment. These changes were accompanied by signs of improved right ventricular function and improved exercise capacity, supporting the notion that iron deficiency has detrimental effects in patients with PH and that treating iron deficiency anaemia in these patients is important. Despite the limitations of a small open label study, the results suggest that oral iron supplementation with ferric maltol might become a safe, effective and convenient treatment option for patients with PH and iron deficiency.

Shield provided the study medication for this study but did not provide financial or logistic support and was not involved in data analysis or writing of this manuscript.

The paper is available online here: https://erj.ersjournals.com/content/erj/early/2020/05/19/13993003.00616-2020.full.pdf

Oral Iron for IBD Patients: Lessons Learned at Time of COVID-19 Pandemic

On 19 May 2020, The Journal of Clinical Medicine published a literature review conducted by Ferdinando D'Amico, Laurent Peyrin-Biroulet and Silvio Danese (J. Clin. Med. 2020, 9(5), 1536; https://doi.org/10.3390/jcm9051536). In the context of the COVID-19 health emergency the authors reviewed alternatives to IV iron to reduce all non-essential hospital activities. They recognised the importance of maintaining iron treatment in patients with inflammatory bowel disease and that oral iron, preferably ferric maltol, could be a suitable alternative for many patients.

Materia Prima, a medical writing company, received financial support from Norgine for this research. Norgine had no involvement in the preparation or development of the content of this manuscript.

The paper is available online here: https://www.mdpi.com/2077-0383/9/5/1536

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About Shield Therapeutics plc

Shield is a de-risked, commercial stage, specialty pharmaceutical company delivering innovative pharmaceuticals to address patients' unmet medical needs.  The Company's clear purpose is to develop products that help patients become people again, enabling them to enjoy the things that make a difference in their everyday lives. The Group's lead product, Feraccru®/ Accrufer® has exclusive IP rights until the mid-2030s and is approved for the treatment of iron deficiency with or without anaemia in adults in the European Union, the United States and Switzerland.  In Europe it is marketed as Feraccru® with commercialisation led by Norgine BV and in the USA the product will be marketed as Accrufer® with Shield currently in the process of selecting a commercialisation partner.  Shield also has an exclusive licence agreement with Beijing Aosaikang Pharmaceutical Co. Ltd for the development and commercialisation of Feraccru®/Accrufer® in China, Hong Kong, Macau and Taiwan.  For more information please visit www.shieldtherapeutics.com

About Feraccru®/Accrufer®

Feraccru®/Accrufer®  is a novel, stable, non-salt based oral therapy for adults with iron deficiency with or without anaemia that has been shown to be an efficacious and well-tolerated therapy in a range of controlled phase 3 trials, and offers a compelling alternative to IV iron for those patients unable to tolerate salt-based oral iron therapies and wish to avoid the complexities of infusion-based iron therapies.

When salt-based oral iron therapies are ingested they can cause a range of mild-to-severe gastrointestinal tract (GI) adverse events, including nausea, bloating and constipation through the release and subsequent reactivity of free iron in the GI tract, leading to poor tolerability, reduced patient compliance and ultimately treatment failure.  Feraccru®/Accrufer® is not an iron salt and, as a result, it does not routinely cause the same treatment-limiting intolerance issues of salt-based iron therapies, whilst the iron from the ferric maltol molecule can be readily absorbed.

Prior to Feraccru®/Accrufer®, IV iron therapies were the only realistic alternative treatment option for iron deficient patients with or without anaemia intolerant of or unwilling to be treated salt-based oral iron therapies.  However, use of such an invasive, costly, inconvenient and complex to administer treatment option, which is associated with potentially life-threatening and spontaneous hypersensitivity reactions, means there remains a clear unmet medical need for these patients to have access to an effective therapy that is well tolerated, convenient and does not require hospital-based administration.  Feraccru®/Accrufer® meets those requirements.

About Iron Deficiency

The WHO states that iron deficiency is the most common and widespread nutritional disorder in the world.  As well as affecting a large number of women and children in non-industrialized countries, it is the only nutrient deficiency which is also significantly prevalent in virtually all industrialised 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-industrialised countries, together with at least 30-40% in industrialized countries, are iron deficient.