Sanofi has reported that its ALTUVIIIO [Antihemophilic Factor (Recombinant), Fc-VWF-XTEN Fusion Protein] showed promise in the Phase III XTEND-Kids study in children with severe haemophilia A.
The non-randomised, open-label, interventional trial evaluated the effects of ALTUVIIIO given once a week in previously treated 73 subjects aged below 12 years with severe haemophilia A.
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These subjects received ALTUVIIIO prophylaxis over a one-year period.
The incidence of factor VIII inhibitors was the trial’s primary endpoint with secondary endpoints examining pharmacokinetics, safety, annualised bleed rates (ABRs) and other health measures.
According to the findings, the trial met these endpoints, indicating no development of inhibitors to factor VIII and ABRs.
Data revealed a median ABR of 0.00, with the estimated mean ABR being 0.61 in trial subjects.
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By GlobalDataIn the trial, 82% of the children receiving ALTUVIIIO experienced no joint bleeds, indicating the treatment’s potential to preserve joint health long-term.
ALTUVIIIO was found to be well-tolerated in trial subjects without any adverse events leading to discontinuation of the treatment.
The most common side effects observed were non-serious and included upper respiratory infections and fever.
ALTUVIIIO, also known as efanesoctocog alfa, is approved for use in both adults and children for routine prophylaxis, on-demand bleeding control, and perioperative management.
Sanofi Development global head and chief medical officer Dietmar Berger said: “The XTEND-Kids data validate the connection between high-sustained factor activity levels and improved health outcomes, including joint health. Offering a treatment option that emphasizes effective bleed protection in children with haemophilia can help give families increased peace of mind when their loved ones participate in everyday activities.
“The results are a testament to our scientific expertise and commitment to redefine the standard of care for children living with haemophilia through ALTUVIIIO and our broader portfolio of haemophilia therapies.”
Recently, the company reported data from a Phase II trial of frexalimab in patients with relapsing multiple sclerosis.
