The following is an excerpt from an update from Takeda. Read the update in its entirety here.
Takeda recently informed HFA of it’s decision聽to suspend screening and further enrollment in聽the TAK-754 and TAK-748 clinical studies, effective immediately.
TAK-754 is an AAV8 gene therapy for the treatment of hemophilia A currently in Phase 1/2 clinical聽development, while TAK-748 is an AAV8 gene therapy for the treatment of hemophilia B in Phase 1/2 study start-up聽(no subject dosed as of today). In order to determine the most appropriate way forward for both TAK-754 and TAK-748, Takeda is currently assessing the interim data from the ongoing Phase 1/2 study of TAK-754 in hemophilia A, together聽with the overall current gene therapy landscape in hemophilia. Takeda will communicate more details on these results to聽the community in due time once their assessment has been finalized. Takeda notes that this decision is not a聽result of any safety concerns with TAK-754 and TAK-748.
Takeda has informed investigators who are working directly on these studies.聽Those who are enrolled will continue to be under close clinical observation聽according to study protocol, and those who were planned to be enrolled into these studies will be informed and聽transitioned smoothly.
Read the update in its entirety here.