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Development Pipeline

We have a responsibility to deliver success

Offering hope for haemophilia A and osteoarthritis sufferers so they can feel as good and as pain-free as possible. Every step we take brings new products closer to safer, less costly, more effective and more quickly available treatments. In haematology, we have three development programmes.

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

Severe haemophilia A patients with inhibitors to FVIII

We intend to begin a Phase II clinical trial in 2018.


Severe haemophilia A patients requiring prophylaxis with subcutaneous FVIII

We are planning a Phase II study to begin in 2019.


Mild / Moderate haemophilia A patients requiring prophylaxis

A development programme is planned to run in parallel with the PBB-8-SQ programme.


Development products


PBB-8-IN is a long acting FVIII, which Ascension intends to trial in HA patients with inhibitors. About 25-30% of severe HA patients develop inhibitors to FVIII replacement therapy, rendering such therapy ineffective. These patients either take on-demand bypass therapies losing the benefits of prophylactic treatment, or undergo costly and unpleasant Immune Tolerance Induction therapy.

Ascension intends to begin a Phase II clinical trial in 2018.


Ascension is using its experience developing nano-lipid based products with PEG to create a SQ version, PBB-8-SQ. Alongside treating patients with inhibitors, one of the biggest drawbacks has been the need for intravenous administration of blood factors. Subcutaneous delivery is much more easily administered, encouraging self-medication and improved compliance. This product is suitable for severe haemophilia A patients who make up approximately 40% of the haemophilia A population and require prophylactic treatment to manage their condition effectively.

Ascension has focused on the benefits of Chaperoned FVIII because of its unique attributes:

  • PEG covalently bonded to the liposome not protein
  • No alteration required to the base protein so no new biologic or chemical entity is formed
  • It improves the performance of plasma derived and recombinant blood factors alike
  • Applies to all haemophiliacs, whether on plasma derived FVIII or rFVIII, providing Ascension with the largest market by meeting the broadest unmet medical need

The unique capability to work with all versions of FVIII and to deliver a subcutaneous solution makes PBB-8-SQ a highly differentiated, market disruptive (and therefore valuable) product.

Ascension is planning a Phase II study to begin in 2019.


PBB-8-CH is a Chaperone, to protect the patient’s own endogenous Factor VIII for mild to moderate haemophiliacs (together about 60% of the haemophilia A population). This may provide affordable prophylaxis for these sections of the haemophiliac community who currently have to rely of treatment on demand (i.e. Accident & Emergency).

A development programme is planned to run in parallel with the PBB-8-SQ programme.