Positive efficacy and tolerance in pediatric trial
FORTIS Phase 3 pediatric trial shows ferric maltol effective and well-tolerated in children aged 2 months and up.
- Treatment-related adverse events in ferric maltol arm 6.5%
- Treatment-related adverse events in ferrous sulfate arm 13%
- Patients discontinuing ferric maltol due to adverse events 0
- Patients discontinuing ferrous sulfate due to adverse events 1
- US iron deficiency market opportunity $2.3B
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London, UK, 01 October 2025 Shield Therapeutics plc (LSE: STX), a commercial-stage pharmaceutical company specialising in iron deficiency, today announced the presentation (virtual and in person) of the positive efficacy, tolerability and palatability results for the ferric maltol pediatric FORTIS clinical trial at the American Association of Pediatrics (AAP) National Conference on 29th September 2025 in Denver, Colorado.
Abstract available online via the AAP Conference website: Browse Poster Hall
| The Poster can be viewed via the Shield website: Publications | Shield Therapeutics plc |
Poster Presentation Details:
Title: P4.017: "Efficacy And Safety Of A Novel Oral Iron (Ferric Maltol) In Children And Adolescents; A Randomized, Multicenter, Open-Label, Active Comparator Study"
Presenter: Dr David Gass MD MS (Associate professor of pediatrics. Carolinas Medical Centre, Charlotte)
Key Results (as previously disclosed):
- Clinically and statistically significant Hb improvements vs. baseline were observed across all groups (ferric maltol arms and ferrous sulfate arm (P<0.0001)
- No patient discontinued ferric maltol treatment due to an adverse event compared to one patient who discontinued from the ferrous sulfate arm.
- Treatment related adverse events (AEs) were reported in 6.5% of patients treated with ferric maltol and 13% of patients treated with ferrous sulphate. No treatment related serious AEs (SAEs) were reported in either group.
Dr Jackie Mitchell, VP of Quality, RA and Clinical Development at Shield, commented: "This first publication of results confirming the safety and effectiveness of ferric maltol treatment in children as young as 2 months is an important milestone for Shield to further the expansion of ACCRUFeR® in this additional patient population who can benefit from a much needed safe and effective oral iron treatment."
Clinically low iron levels (aka iron deficiency, ID) can cause serious health problems for adults of all ages, across multiple therapeutic areas. Together, ID and ID with anemia (IDA) affect about 20 million people in the US and represent a $2.3B market opportunity. As the first and only FDA approved oral iron to treat ID/IDA, ACCRUFeR® has the potential to meet an important unmet medical need for both physicians and patients and is now the leading #1 branded prescription oral iron in the market today (data source - IQVIA Xponent PlanTrak).
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