Shield Therapeutics PLC (AIM:STX, OTCQB:SHIEF) has announced positive results from its phase III pediatric FORTIS trial of ferric maltol (ACCRUFeR).
The trial tested children and adolescents with iron deficiency using ferric maltol against ferrous sulfate, and, the data was presented at the American Association of Pediatrics conference on 29 September, in Denver.
"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," said Shield Therapeutics vice president Dr Jackie Mitchell.
Clinically significant improvements in haemoglobin were observed across all groups. No patients discontinued ferric maltol due to adverse events, while one discontinuation occurred in the ferrous sulfate group.
Treatment-related adverse events were reported in 6.5% of ferric maltol patients versus 13% with ferrous sulfate.