Shield Therapeutics - AEGIS-H2H study update
The information contained within this announcement is deemed by the Group to constitute inside information as stipulated under the Market Abuse Regulation (EU) No. 596/2014. Upon the publication of this announcement via the
("Shield" or the "Group" or the "Company")
AEGIS-H2H study update
This update has no impact on existing marketing authorisations in the EU, US and
Based on a range of positive clinical trials Feraccru®/Accrufer® is approved for the treatment of iron deficiency in adults with or without anaemia in the
The above statement was made in relation to the "per protocol" (PP) analysis of the study results. These data have been published and presented at both the United European Gastroenterology Week (UEGW)1 and European Crohn's and
However, the pre-defined success criteria of this clinical study, as set out in the statistical analysis plan, inadvertently required that ferric maltol could be considered non-inferior to IV iron if the difference in the proportion of responders in each arm at week 12 was less than 20% in both the ITT and the PP analyses, but should have allowed for non-inferiority if either the PP or ITT populations achieved this target. In the ITT analysis (which refers to all patients who were randomised into the study, whether or not they completed the entire 12-week period and fully complied with the study design), Feraccru®/Accrufer® clearly demonstrated effectiveness, but did not achieve non-inferiority compared to the IV iron therapy. The
In light of the above finding which has just come to light, the Board has instigated an immediate independent review into the analysis of both datasets, which is being overseen by a non-executive director. The Company will update the market on this review in due course.
As stated above, this clarification has no impact on existing marketing authorisations, nor on any approved prescribing information and the data was not used in the regulatory submissions that led to the approval of Feraccru®/Accrufer® in either
In the meantime, the Company is working closely with its commercial partners to ensure relevant information is clearly communicated to all stakeholders in a timely manner.
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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
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.
1. Howaldt S et al. OP195.
2. Howaldt S, et al. P685, presented at ECCO 2020; Howaldt S, et al. P331, presented at ECCO 2020, Howaldt S, et al. P567, presented at ECCO 2020
This information is provided by RNS, the news service of the
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