GCISTX’s ferric maltol demonstrates potential to treat inflammatory bowel disease
(STX ) has revealed positive findings from a recent real-world study of ferric maltol assessing clinical characteristics and outcomes of patients with inflammatory bowel disease (IBD) that were also receiving ferric maltol for iron-deficiency anaemia in the UK.
The data was published in BMJ Open Gastroenterology under, "Ferric maltol Real-world Effectiveness Study in Hospital practice: clinical characteristics and outcomes of patients with inflammatory bowel disease receiving ferric maltol for iron-deficiency anaemia in the UK."
The study, which assessed the clinical characteristics and outcomes of patients with IBD that were also receiving ferric maltol for iron-deficiency anaemia in the UK (FRESH Study), confirmed ‘favourable benefit/risk balance findings’ from randomised control trials.
The Group, which is focused on addressing iron deficiency, said the clinical study found that ferric maltol increases haemoglobin and iron indices and is ‘generally well tolerated’ in patients with both IBD and iron deficiency anemia (IDA) treated in clinical practice.
STX’s lead product, Feraccru®/Accrufer® is already approved for use in the US, European Union, UK and Switzerland and has exclusive IP rights until the mid-2030s. Earlier this month, Australia's Therapeutic Goods Administration approved Feraccru® as a treatment.
In particular, Shield views the US market opportunity for Accrufer® as ‘substantial and growing’. A recent head-to-head study identified Accrufer® to be a credible alternative to IV therapy particularly for maintaining haemoglobin levels over the long term.
Shield recently raised up to £25m which it said will be used to finance the US launch of Accrufer® in the US which it believes has the potential to generate significant returns.
Accrufer® was approved in July 2019 by the United States FDA for the broad indication of treatment of iron deficiency in adults. Since then, the Company has conducted an extensive process in order to identify and appoint a commercialisation partner for the US market.
Sales estimates generated by management consultants and other third parties support the potential for sales of Accrufer® in the US to exceed $100 million from the third year following launch and to reach $300 million-$400 million by years five to six, it noted.
Despite shares having more than halved in recent months following the news that STX would not be signing a US marketing deal before the end of 2020, STX’s Directors believe the recent fundraising fulfils the necessary requirements for a Shield-led US launch of Accrufer®, a pathway they view as having the potential to generate significant returns for shareholders.
Potential sales estimates for Accrufer® in the US are forecasted to exceed $100m from the third year following launch and to reach $300m-$400m by years five to six, which would generate a significant upside to the placing price. Shares in STX were trading 0.59% higher at 34p today following the release of positive data from a real-world study of ferric maltol.
Reasons to STX
Shield is a de-risked, specialty pharmaceutical company focused on commercialising its lead product, Feraccru®/Accrufer®, a novel, non-salt based oral therapy for adults with iron deficiency with or without anaemia.
Proven and Approved
The Group’s Feraccru®/Accrufer® product has been approved for use in the United States, European Union, UK and Switzerland and has exclusive IP rights until the mid-2030s.
Feraccru® is commercialised across the UK and European Union by Norgine B.V. and the Company is currently in the process of evaluating commercialisation options for the US market, including the potential launch of Accrufer® in the US by Shield.
Shield also has an exclusive licence agreement with Beijing Aosaikang Pharmaceutical to develop and commercialise Feraccru®/Accrufer® in China, Hong Kong, Macau and Taiwan.
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