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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
SelectAte

Severe haemophilia A patients with inhibitors to FVIII

We intend to enter a Phase II clinical trial in 2019.

READ MORE ON SelectAte
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 2019.

READ MORE ON SubcutAte
ChapAte

Mild / Moderate haemophilia A patients requiring prophylaxis

A development programme is planned to run in parallel with the SubcutAte programme.

READ MORE ON ChapAte

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 intends to enter a Phase II clinical trial in 2019.

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 in 2019.

ChapAte

ChapAte is directed at treating mild (5-40% of normal FVIII) and moderate (1-5% of normal FVIII) HA patients on a prophylactic basis. Such patients are usually treated with FVIII on demand and not prophylactically. Mild patients can also be treated with desmopressin on demand that boosts plasma levels of FVIII.  Although technically a more challenging project than SelectAte and SubcutAte, if the proposed clinical trial is successful, ChapAte potentially provides a new prophylaxis for mild to moderate HA patients.

A development programme is planned to run in parallel with the SubcutAte programme.

Despite new product introductions and further products in late development, the market opportunity for these product profiles remains substantial.  The treatment market for HA is approximately $8.9bn, of which:

  • $6.6bn is focused on replacement factors. (80% of the market value is concentrated in four players)
  • $2.3bn focused on alternative (bypass) products (concentrated in two major players).