- Shield Therapeutics
- 25 September 2024 14:56:34
Source: Sharecast
The AIM-traded firm said the trial showed significant efficacy, safety, and tolerability of the oral liquid suspension, paving the way for regulatory submissions to the US FDA and the EMA in Europe for a paediatric indication in children older than one month in the first half of 2025.
It said the study, known as FORTIS/ST10-01-305, met all primary endpoints, showing a clinically relevant increase in haemoglobin (Hb) levels over 12 weeks.
In children aged two to 17, the mean Hb increase was 1.25 grams per decilitre, while infants showed an increase of 1.77 grams per decilitre.
Comparatively, the ferrous sulphate group saw a mean increase of 1.15 grams per decilitre.
Importantly, no patients in the ferric maltol group discontinued the study due to treatment-related adverse events.
The data would be used to support Shield's regulatory filings for paediatric use in both the US and Europe.
Additionally, the company said it expected to receive €1m development milestones from its European partner, Norgine, following compliance notifications and approval of the paediatric indication by the EMA.
“We are delighted that the results in this important Accrufer/Ferracru paediatric phase three study show similar levels of efficacy and safety as in prior trials with adults,” said interim chief executive officer Anders Lundstrom.
“We will now initiate the work with the regulatory applications to be able to expand the patient population who can benefit from a safe and effective oral iron treatment.”
At 1436 BST, shares in Shield Therapeutics were up 5.67% at 3.8p.
Reporting by Josh White for Sharecast.com.