TIDMSTX
Shield Therapeutics PLC
03 June 2020
Shield Therapeutics plc
("Shield" or the "Group" or the "Company")
Feraccru(R)/Accrufer(R) 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 (R) /Accrufer(R)
(ferric maltol), notes the recent publication of two papers
concerning Feraccru (R) /Accrufer(R) .
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
For further information please contact:
Shield Therapeutics plc www.shieldtherapeutics.com
Tim Watts, CEO +44 (0)20 7186 8500
Karen Chandler Smith, Investor
Relations
Nominated Adviser and Joint
Broker
Peel Hunt LLP
James Steel/Dr Christopher
Golden +44 (0)20 7418 8900
Joint Broker
finnCap Ltd
Geoff Nash/Matt Radley/Alice
Lane +44 (0)20 7220 0500
Financial PR & IR Advisor
Walbrook PR +44 (0)20 7933 8780 or shield@walbrookpr.com
+44 (0)7980 541 893 / +44 (0)7584 391
Paul McManus/Lianne Cawthorne 303
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 (R) / Accrufer
(R) 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 (R) with commercialisation led by
Norgine BV and in the USA the product will be marketed as Accrufer
(R) 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(R)/Accrufer(R) in
China, Hong Kong, Macau and Taiwan. For more information please
visit www.shieldtherapeutics.com
About Feraccru(R)/Accrufer(R)
Feraccru (R) /Accrufer(R) 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 (R) /Accrufer(R) 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 (R) /Accrufer(R) , 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 (R) /Accrufer(R)
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.
This information is provided by RNS, the news service of the
London Stock Exchange. RNS is approved by the Financial Conduct
Authority to act as a Primary Information Provider in the United
Kingdom. Terms and conditions relating to the use and distribution
of this information may apply. For further information, please
contact rns@lseg.com or visit www.rns.com.
END
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