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Development Pipeline

We have a responsibility to deliver success


Offering hope for haemophilia A (HA) sufferers so they can feel as good and as pain-free as possible. Every step we take brings safer, less costly and more effective treatments closer towards approval. In haematology, we have three programmes in development.

Product/Programme Pre-clinical Phase I Phase II Phase III
SelectAte

Severe haemophilia A patients with inhibitors to FVIII

Phase II study completed 2022, Phase III planning

READ MORE ON SelectAte
XLR8

Mild/moderate haemophilia A patients or severe patients on a standard of care prophylaxis with FVIII

Phase II study completed 2022, Phase III planning

READ MORE ON XLR8
SubcutAte

Severe haemophilia A patients requiring prophylaxis with subcutaneous FVIII

Ascension has commenced a pre-clinical programme with a view to Phase II clinical readiness in 2023

READ MORE ON SubcutAte

Development products

SelectAte

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 has completed a Phase II trial and results are expected to be announced over the coming months.

XLR8

XLR8 is a subcutaneous form of PEGLip administered as an adjuvant to patients who already have some circulating FVIII. Preferably this will be severe patients who are receiving standard of care prophylaxis with IV FVIII, where the adjuvant will extend their IVFVIII dosing interval, improving compliance. XLR8 has completed Phase II clinical trial for the sequential IV administration of PEGLip and FVIII and is undergoing preclinical studies for subcutaneous administration in non-inhibitor patients. The results of the Phase II trial and results are expected to be announced over the coming months.

SubcutAte

SubcutAte is a FVIII replacement therapy directed at severe HA patients that have not gone on to develop inhibitors that:

  • can be more conveniently and comfortably administered subcutaneously (i.e. under the skin, not through the vein) as a small bolus on a daily basis in contrast to intravenous injection; and
  • will enter the circulation over time, with the aim of achieving a stable circulating level of treated FVIII, in contrast to intravenous administration. Intravenous administration has a “saw-tooth” concentration profile caused by periodic injections where the high doses of initial FVIII levels after dosing are run down (potentially to sub-optimal levels) and are restored by subsequent injections that are wasteful and potentially leaves the patients without cover.

Ascension has commenced a pre-clinical programme with a view to Phase II clinical readiness.