Shield Therapeutics PLC (LON:STX) will present compelling data from its phase IIIb clinical trial that shows its lead drug Feraccru offers a “real oral alternative” to intravenous (IV) iron for patients with iron deficiency anaemia.
The data, which was the backbone of a successful US regulatory submission, shows the treatment, also known as Accrufer in the States, was “non-inferior” to the standard of care – an IV infusion.
WATCH: Shield Therapeutics to present data showing Feraccru offers 'real oral alternative'
It was also a simple-to-administer, well-tolerated and efficacious treatment that required no hospital care, the study concluded.
Crucially, over a year it prevented the recurrence of iron deficiency anaemia, whereas 39% of the people in the IV treatment group required further “intervention” due to a return of iron deficiency anaemia.
Principal investigator Dr Stefanie Howaldt, from the MVZ-Immunology Clinic in Hamburg, said: "This data shows that not only is Feraccru a real oral alternative to IV iron for these patients with iron deficiency anaemia, but that it can also prevent the need for repeated IV infusions."
Howaldt will share the phase IIIb results with delegates at the United European Gastroenterology Week in Barcelona later Tuesday.
On July 26 the Food & Drug Administration (FDA) awarded the treatment a broad label to treat iron deficiency in adults, addressing a population many times wider than the iron-deficiency anaemia indications included in the submission data.
There are around three times as many patients with iron deficiency than with iron deficiency anaemia. That means the total addressable population could reach up to 40mln in the US, according to Proactive Research’s Emma Ulker.