Swedish Orphan Biovitrum’s Promising Study on Efanesoctocog Alfa for Haemophilia A

Swedish Orphan Biovitrum Ab ((GB:0MTD)) announced an update on their ongoing clinical study.

Swedish Orphan Biovitrum is conducting a clinical study titled An Open-label, Multicentre Study to Compare the Pharmacokinetics of Efanesoctocog Alfa Versus rFVIII Products, Damactocog Alfa Pegol or Turoctocog Alfa Pegol, After a Single Intravenous Dose of 50 IU/kg in a Fixed Sequence in Previously Treated Adults With Severe Haemophilia A. The study aims to compare the pharmacokinetic profiles of efanesoctocog alfa with two other extended half-life rFVIII products in adults with severe Haemophilia A, focusing on the half-life and safety of these treatments.

The intervention being tested is efanesoctocog alfa, a recombinant coagulation factor VIII Fc-von Willebrand Factor-XTEN fusion protein. It is intended to improve the treatment of severe Haemophilia A by potentially offering a longer half-life compared to existing treatments.

The study is designed as an open-label, non-randomized, sequential intervention model. Participants will first receive their current treatment (either damactocog alfa pegol or turoctocog alfa pegol) followed by efanesoctocog alfa, with no masking involved. The primary purpose is to compare pharmacokinetic profiles.

Key dates for the study include a start date of August 28, 2024, and a last update on April 2, 2025. These dates are crucial for tracking the study’s progress and ensuring timely updates to stakeholders.

This study could significantly impact Swedish Orphan Biovitrum’s market position by potentially introducing a superior treatment option for Haemophilia A. Positive results may boost investor confidence and stock performance, especially in comparison to competitors in the haemophilia treatment market.

The study is ongoing, with further details available on the ClinicalTrials portal.