~ Progress across Haemophilia clinical programmesand further expansion of Consumer Healthcare business~
LONDON, November29, 2021 – Ascension Healthcare plc (“Ascension” or the “Company”), a clinical-stage biopharmaceutical company focused on developing and commercialising innovative therapies for haemophilia and osteoarthritis, today provides an update on its haemophilia clinical programmes and consumer healthcare business.
BUSINESS UPDATE
Haemophilia Ascension’s ‘SelectAte’ Phase 2 clinical development programme is aimed at evaluating the efficacy and safety of the Company’s proprietary pegylated liposome (PEGLip) technology in providing prophylactic Factor VIII (FVIII) replacement therapy to inhibitor and non-inhibitor patients suffering from severe Haemophilia A. SelectAte involves the intravenous co-administration of PEGLip with a commercially available recombinant FVIII. The inhibitor arm of the study is almost complete with 9 patients out of 10 processed and the non-inhibitor arm comprising 10 patients has completed. Positive results have been observed to date across both arms indicating the potential for a safe FVIII replacement treatment for inhibitor patients and an extension of dosing interval when compared to existing FVIII replacement therapies.
Ascension’s ‘XLR8’ (formerly ‘ChapAte’) Phase 2 clinical programme is aimed at evaluating the efficacy and safety of the Company’s PEGLip technology in prophylactically treating non-inhibitor patients via a separate administration of PEGLip, following an initial loading dose of FVIII. Positive results were obtained from this study, also indicating the potential for an extended dosing interval, without compromising haemostatic cover, in patients currently receiving prophylactic FVIII standard of care.
Final study reports will be available for both SelectAte and XLR8 in Q1 2022.
Dr Gavin Ling, Chief Medical Officer of Ascension commented: “It is very encouraging to see initial positive data from both the SelectAte and XLR8 trials, demonstrating the potential of our PEGLip technology in providing prophylactic FVIII replacement therapy to patients suffering from severe Haemophilia A. We look forward to announcing the full data sets for both trials early next year and are excited about moving into Phase 3 with a dosing interval that extends beyond any currently licensed FVIII treatment.”
Biresh Roy, Chief Executive Officer of Ascension added: “Ascension is excited to provide this update regarding the positive clinical progress of its lead Haemophilia A programmes, which offer the potential for safe, effective FVIII replacement therapies, particularly for inhibitor patients. The results are further evidence of our unique PEGylated liposomal technology in this area of unmet medical need and provide a firm foundation as the company seeks financing to progress its studies into Phase 3 clinical development in 2022.”
Consumer Healthcare Despite the challenges of COVID-19, Ascension’s Consumer Healthcare business performed strongly during the period. Earlier in the year, the Company successfully rebranded its core FlexiSEQ product, containing Ascension’s patented Sequessome® technology (SEQ Tech®) in a topical formulation. The Company expanded its offering with the introduction of 30g and 100g pack sizes for FlexiSEQ, an equine version under the brand name Nanoflex in the U.S and a CBD Oil product. The business also continued to expand into new geographies, particularly in Asia and the Middle East through distributors.
AMERICAN SOCIETY OF HEMATOLOGY(ASH) CONFERENCE Ascension will be presenting a poster at the 63rd annual gathering of the American Society of Hematology in Atlanta, Georgia from 11th -14th December 2021 headlining interim results from the inhibitor arm of the SelectAte Phase 2 study. Further information will be announced in due course, and anyone interested in meeting the Company should contact Consilium Strategic Communications on the details below.
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.
About Haemophilia The Company’s product development programmes are focused on treating a form of haemophilia, haemophilia A (“HA”), 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, affecting 80% - 85% of the total haemophilia population. HA has a prevalence rate of about 1 in 10,000 births and can be categorised from mild (5-40%) to moderate (1-5%), to severe (<1%) circulating FVIII depending on the actual level of functioning FVIII in the body.
The Company has developed and acquired intellectual property over several years (PEGylated liposomes and PEGylated blood proteins) with the intention of developing novel products for haemophiliacs, principally to deal with problems relating to the development of inhibitors in severe haemophiliacs, the lack of a convenient, safe, effective and economical prophylactic treatment administered by subcutaneous injection for severe haemophiliacs and the need for a prophylactic treatment to boost existing FVIII levels in moderate and mild HA patients.
About FlexiSEQ FlexiSEQ is a topical gel designed to support joint health and mobility. Unlike many topical gels for joint pain, FlexiSEQ is drug-free so can be used long-term by patients who are sensitive to, or cannot take, traditional pain medications. Ascension’s patented Sequessome® technology (SEQ Tech®) contained within FlexiSEQ’s topical formulation means that FlexiSEQ is safe and drug-free. User experience and clinical studies have shown significant benefits for users in improved joint health, mobility, and a reduction in the need for painkillers leading to an improved quality of life.
