Ascension Healthcare to Present Positive Phase 2 Data on Two Haemophilia Programmes at the 64th American Society of Hematology Annual Meeting

Ascension Healthcare to Present Positive Phase 2 Data on Two Haemophilia Programmes at the 64^th American Society of Hematology Annual Meeting

• Data demonstrates the potential of SelectAte and XLR8 for the treatment of severe haemophilia A patients
  
  

LONDON, 3 November 2022 – Ascension Healthcare plc (“Ascension” or the “Company”), a clinical-stage biopharmaceutical company focused on developing and commercialising innovative therapies for haemophilia and osteoarthritis, today announces that abstracts detailing positive data from its two Phase 2 clinical trials of SelectAte and XLR8, have been selected for poster presentations at the 64^th American Society of Hematology (ASH) Annual Meeting. The ASH annual meeting will take place from the10-13 December 2022 in New Orleans, Louisiana and virtually.

Professor Edward Tuddenham, Emeritus Professor of Haematology at University College London and member of Ascension’s Medical and Scientific Advisory Board will present data from the Company’s Phase 2 open-label, multicentre SelectAte trial, completed with 24 severe haemophilia A patients focussing on those with, or prone to generate, inhibitors to factor VIII FVIII), and separately the Phase 2 open-label, multicentre XLR8 trial completed with 14 severe haemophilia A patients without inhibitors to FVIII.

Biresh Roy, Chief Executive Officer at Ascension commented: “We are immensely privileged to have been selected to present our successful Phase 2 SelectAte and XLR8 programmes at ASH, a world leader in supporting and promulgating clinical and scientific developments in haematology. The data from these studies demonstrate the potential of both of these programmes in applying our patented approach to PEGLip as an investigational drug for the treatment of haemophilia A. SelectAte aims to prophylactically treat severe haemophilia A patients who have developed inhibitors (neutralising antibodies) to FVIII. XLR8, a form of PEGLip administered as an adjuvant to patients who already have some circulating FVIII, is designed to extend the FVIII dosing interval, thereby improving patient compliance.”

Full details of the poster presentations are:

SelectAte:

Title: Prophylactic Treatment of Severe Haemophilia A Patients with Inhibitors to FVIII with PEGLip-FVIII
Publication Number: 2477
Session Name: 322. Disorders of Coagulation or Fibrinolysis: Clinical and Epidemiological: Poster II
Session Date: Sunday, December 11, 2022
Presentation Time: 6:00 PM - 8:00 PM
Location: Ernest N. Morial Convention Center, Hall D

XLR8:

Title: The Use of a PEGylated Liposome in a Phase II Trial to Enhance the Potency and Extend the Dosing Interval of Prophylactic Standard Half-Life FVIII, without Increasing the Dose
Publication Number: 2464
Session Name: 322. Disorders of Coagulation or Fibrinolysis: Clinical and Epidemiological: Poster II
Session Date: Sunday, December 11, 2022
Presentation Time: 6:00 PM - 8:00 PM
Location: Ernest N. Morial Convention Center, Hall D

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About Ascension Healthcare plc

Ascension Healthcare plc is a clinical-stage biopharmaceutical company focused on developing and commercialising innovative therapies for the treatment of haemophilia and osteoarthritis. The Company has three products in clinical development for the treatment of haemophilia A and also a range of internationally marketed products for osteoarthritis sufferers. For more information please visit: www.ascension.co.uk/

About Haemophilia A
Haemophilia A (“HA”) is a congenital bleeding disorder which leaves a patient at risk of uncontrolled bleeding due to a lack of blood clotting Factor VIII (“FVIII”). HA is the most common form of haemophilia with a prevalence rate estimated at 1.7 - 2.5 in 10,000 male births and can be categorised from mild (5-40%of normal circulating FVIII) to moderate (1-5% of normal), to severe (<1% of normal); of these severe HA is prevalent in circa 0.6 to 1 in 10,000 males (World Federation of Haemophilia Global Survey 2021). The global market for haemophilia A treatments was estimated to be worth approximately $11 billion in 2021, (Ascension Healthcare research)

About 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 FVIII replacement therapy, rendering such therapy ineffective for prophylaxis. Current options for these patients are (i) Immune Tolerance Induction Therapy (ITI) to eradicate inhibitors, which is costly, lengthy, unpleasant and sometimes unsuccessful; (ii) bypassing blood factor agents to treat or prevent bleeds on demand or (iii) non-factor agents administered 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 replacement FVIII treatment.

About XLR8
XLR8 is a form of PEGLip administered as an adjuvant to patients who already have some circulating FVIII. The therapy is primarily aimed at severe patients who are receiving standard of care prophylaxis with intravenous FVIII, where the adjuvant will extend their FVIII dosing interval, thereby improving compliance.