Shield Therapeutics soars 21% following positive clinical trial
shares soared over 21% following the news that a phase III clinical trial showed Feraccru® to be non-inferior to market-leading intravenous (IV) iron therapy.
Feraccru® is a novel oral iron replacement therapy for treating iron deficiency anaemia, the most common and widespread nutritional disorder in the world, according to the WHO.
In a head-to-head clinical trial comparing it to Ferinject®, Feraccru® was efficiently absorbed and well tolerated over an extended treatment period.
The study showed that response to Feraccru® at 12 weeks was within 9% of the response seen with Ferinject® and within the 20% limit required by the study protocol to confirm non-inferiority.
Carl Sterritt, CEO and Founder of Shield, said: "We are delighted that Feraccru® has once again performed so well in a phase III clinical trial, this time delivering a major achievement in showing itself to be non-inferior to IV iron therapy, further reinforcing the value of Feraccru®.”
“We are particularly pleased to see such a clinically relevant response to Feraccru® throughout the pre-defined assessment timepoints in this complex study, having previously seen very similar long-term benefits in IBD patients with IDA in the AEGIS-IBD study.”
Shield Therapeutics are now due to receive a €2.5m development milestone payment from Norgine B.V. as per its previous agreement.
Dr Mark Sampson, Chief Medical Officer of Shield, said: "In a challenging phase IIIb clinical study, in which Feraccru® has been tested against Ferinject®, the standard of care for patients who cannot tolerate or are unwilling to take salt-based oral iron therapies, orally delivered Feraccru® has demonstrated it is non-inferior to IV iron therapy in treating iron deficiency anaemia.”
Feraccru® offers the market a simple, well tolerated, efficacious oral treatment alternative to IV iron therapy without need for hospital administration. A New Drug Application for Feraccru® in the USA is being reviewed by the FDA with a PDUFA date of 27 July 2019.
Feraccru® is approved and marketed in the European Union for the treatment of iron deficiency (ID) in adults and in Switzerland for the treatment of iron deficiency anaemia (IDA) in adults with inflammatory bowel disease (IBD).
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