Shield Therapeutics (AIM:STX), the commercial-stage pharmaceutical company specialising in iron deficiency treatments, said the Phase 3 FORTIS pediatric trial results for ferric maltol have been published in the journal Pediatric Drugs.
The trial compared ferric maltol against ferrous sulfate for treating iron deficiency anaemia in infants, children and adolescents.
Haemoglobin levels improved significantly against baseline across all treatment arms, with statistical significance at P<0.0001.
No patient discontinued ferric maltol due to an adverse event, against one discontinuation in the ferrous sulfate arm.
Treatment-related adverse events occurred in 6.5% of ferric maltol patients compared with 13% on ferrous sulfate, with no serious treatment-related events in either group.
Professor Richard Russell, the study's Principal Investigator, said the publication "confirming the safety and effectiveness of ferric maltol treatment in children as young as 2 months is an important milestone in expanding therapeutic choices for pediatric patients".
The capsule formulation is already approved for adolescents and adults, marketed as ACCRUFeR in the US for those aged 10 and above and as FeRACCRU in the EU for ages 12 and up.
Shield plans to register the liquid formulation used in the FORTIS trial to support treatment of younger children from age two, extending the drug's addressable patient population beyond its current approvals.
News Intelligence what this means for the company
Shield Therapeutics published Phase 3 FORTIS trial results showing ferric maltol was safer and better tolerated than ferrous sulfate in children aged 2 months to adolescence, with 6.5% treatment-related adverse events versus 13% for the comparator and zero discontinuations due to adverse events. The peer-reviewed publication clears a regulatory dependency and positions the company to file for approval of a liquid formulation in children as young as age 2, expanding ACCRUFeR's addressable market beyond its current 10+ (US) and 12+ (EU) age restrictions.
The published data de-risks the pediatric label extension and removes a key milestone uncertainty. Success in younger children materially widens the commercial opportunity, though regulatory approval and uptake in a new age group remain ahead.
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