Octapharma has reportedly presented an update on the clinical development and pre-clinical data of SubQ-8 in a conference at the International Society on Thrombosis and Haemostasis Congress 2019. SubQ-8 integrates a human cell line-derived recombinant FVIII simoctocog alfa with a recombinant VWF fragment dimer from a human cell line, in a unique approach to enable uptake of subcutaneous FVIII into the circulation.
Larisa Belyanskaya, Head of Haematology International Business Unit at Octapharma, stated that the organization is thrilled to share the update and future plans for the clinical development of the drug with the haemophilia community at the ISTH Congress. The organization believes that subcutaneous administration of FVIII could be critical in helping patients to receive a ‘state of the art’ treatment for haemophilia A and that it is pleased with the favorable preclinical data with SubQ-8 and its response among the haemophilia community, she added.
Olaf Walter, Octapharma’s Board Member, was quoted saying that Octapharma is dedicated to the enhancement of lives of the people with coagulation disorders and the company is proud to be creating a product with so much potential to meet a major need for patients with haemophilia A.
Walter further added that the ISTH Congress accords with the registration of the first patient in phase 1/2 clinical study of SubQ-8 in formerly treated patients suffering from haemophilia A, which is a major breakthrough in the clinical development of this drug.
According to credible sources, the scientific symposium considered how SubQ-8 could possibly address the longstanding needs of individuals with haemophilia A. Consistent intravenous supply of FVIII poses a substantial burden to patients with haemophilia A and their families. Alternate routes of administration may assist in reducing this burden and enhance adherence to prophylaxis.
The first candidate is about to be registered in a phase 1/2 study to evaluate safety and pharmacokinetics of the product in formerly treated patients with haemophilia A, and the outcomes of this study will decide the right dosing of SubQ-8 in forthcoming phase 3 studies among adults and children, reported sources.