Shield Therapeutics Shares Rise 8% Following Phase III Trial Success

2 min read | September 25, 2024 07:20 AM PDT | By Team Kalkine Media

Shield Therapeutics Shares Rise 8% Following Phase III Trial Success — Image source: shutterstock

Highlights

Positive Phase III Trial Results: Shield Therapeutics announced successful phase III trial results for its iron deficiency treatment, Accrufer, demonstrating significant efficacy in pediatric patients.

Efficacy in Children: The oral medication, ferric maltol, resulted in an average hemoglobin increase of 1.25 g/dL over 12 weeks in children aged 2 to 17, with even better outcomes noted in infants.

Regulatory Plans and Financial Milestones: The company aims to seek regulatory approval for Accrufer’s use in children over one month old by mid-2025 and expects a €1 million milestone payment from partner Norgine upon European Medicines Agency approval.

Description

Shield Therapeutics PLC (OTC:SHIEF) has experienced an 8% increase in its share price following the announcement of promising phase III trial results for its iron deficiency treatment, Accrufer. This oral drug, scientifically known as ferric maltol, has shown significant efficacy and safety in pediatric patients aged 2 to 17. The trial results revealed an impressive average hemoglobin increase of 1.25 g/dL over a 12-week period, indicating the drug's potential in addressing iron deficiency in younger populations. Notably, even higher efficacy was observed in infants, marking a substantial achievement in Shield's development program.

With the successful completion of the trial, Shield Therapeutics is now preparing to seek regulatory approval for the use of Accrufer in children older than one month in both Europe and the United States, with a target date set for mid-2025. This move could expand the market for Accrufer significantly, as there is a recognized need for effective treatments in this demographic.

Additionally, the company anticipates a €1 million milestone payment from its partner, Norgine, contingent upon receiving approval from the European Medicines Agency. The acknowledgment of the unmet medical need for Accrufer is underscored by estimates indicating that around 20 million patients in the United States alone are affected by anemia.

Market traction for Accrufer will depend on continued efforts and investments in marketing and commercialization strategies, positioning Shield Therapeutics for potential growth in the pediatric treatment landscape. As the company moves forward, it will be pivotal in addressing the pressing needs of iron deficiency among children.

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