SelectAte is being developed to treat severe HA patients who have developed inhibitors (neutralising antibodies) to FVIII. Approximately 30% of severe HA patients develop inhibitors to prophylactic FVIII replacement therapy, rendering such therapy ineffective. Current options for these patients are (i) Immune Tolerance Induction Therapy (ITI) to eradicate inhibitors, which is costly, lengthy and sometimes unsuccessful, and unpleasant or (ii) bypassing agents to treat or prevent bleeds on demand or (iii) prophylactically which can be very costly; some of these agents have an FDA “black box” safety warning (risk of blood clots and death).
This is a large market that is, at present, not served by a safe, convenient, inexpensive prophylactic treatment.
Ascension intends to enter a Phase II clinical trial in 2019.