Octapharma Share Promising Preclinical Data for SubQ-8, a Novel Subcutaneous Recombinant FVIII, at WFH 2018

LACHEN, Switzerland I May 28, 2018 I Octapharma announced today that pre-clinical data for SubQ-8 were presented during a symposium at the recent World Federation of Hemophilia (WFH) 2018 World Congress in Glasgow, UK. SubQ-8, currently under development, is a recombinant FVIII from a human cell line for subcutaneous administration. SubQ-8 is based on Octapharma’s human cell line-derived rFVIII product simoctocog alpha combined with a fragment of the von Willebrand Factor (VWF) protein, and harnesses the protective power of VWF in an innovative approach to facilitate transportation of FVIII into the circulation.

Regular intravenous administration of FVIII poses a considerable burden to people with haemophilia A and their families. Alternative routes of administration may help to alleviate some of this burden and improve adherence to prophylaxis therapy.

This symposium, entitled ‘Taking FVIII into the future: The development of subcutaneous recombinant human FVIII for the treatment of haemophilia A’, reviewed the challenges that intravenous administration poses to people with haemophilia A on a daily basis, and presented data on the uptake of SubQ-8 into the vasculature following subcutaneous administration in animal models.

David Lillicrap (Queens University, Ontario, Canada) chaired the symposium and introduced the relevance of SubQ-8 within the rapidly advancing haemophilia treatment field. Cedric Hermans (Saint-Luc University Hospital, Brussels, Belgium) discussed the important role of FVIII, and the use of FVIII therapy as a natural approach to restoring blood clotting in haemophilia A. The proven benefits of FVIII prophylaxis include protecting from devastating intracranial bleeds and reducing the risks of long term joint damage. Dr Hermans also presented the challenges and burdens of intravenous infusion of FVIII, which may present a hurdle to initiating and adhering to prophylaxis. As a result, there is demand for a simpler FVIII administration method.

Christoph Kannicht (Octapharma Research & Development, Berlin, Germany) explained the rationale for the development of SubQ-8, and addressed the challenge of achieving sufficient FVIII bioavailability after subcutaneous infusion. Pre-clinical data in the animal models showed 45.5% bioavailability of FVIII after subcutaneous administration of SubQ-8, and a 3.6-fold prolongation of FVIII half-life compared with FVIII intravenous infusion. Andreas Tiede (Hannover Medical School, Hannover, Germany) addressed the immunogenicity risk of protein therapeutics administered subcutaneously or intravenously, concluding that there is no evidence for a difference in risk. The immunogenicity of SubQ-8 has been studied in mice and subcutaneous administration of SubQ-8 resulted in a slower development of anti-FVIII antibodies than intravenous administration of FVIII.

The data presented represent a promising basis for future clinical studies of SubQ-8. Larisa Belyanskaya, Head of Octapharma’s IBU Haematology, said “WFH was a fantastic platform to share the most recent data on the development of our new subcutaneous FVIII product, SubQ-8. We at Octapharma believe that SubQ-8 could play an important role in ensuring patients receive optimal treatment for haemophilia A”. Olaf Walter, Board Member of Octapharma, added that “Octapharma is committed to improving patients’ lives and we are proud to be developing a product with such potential for the haemophilia field. Presenting our preclinical data at WFH is an important step in realising our goal”.

About SubQ-8

SubQ-8 is Octapharma’s developmental rFVIII product for subcutaneous administration, currently in the preclinical stage.

About Haemophilia A

Haemophilia A is an X-linked hereditary disorder caused by FVIII deficiency which, if left untreated, leads to haemorrhages in muscles and joints and consequently to arthropathy and severe morbidity. FVIII replacement prophylactic treatment reduces the number of bleeding episodes and the risk of permanent joint damage. This disorder affects one in every 5,000 to 10,000 men worldwide. Globally, 75% of haemophilia cases are left undiagnosed or untreated. The development of neutralising FVIII antibodies (FVIII inhibitors) against infused FVIII represents the most serious treatment complication. The cumulative risk of FVIII inhibitor development is reported to be currently up to 39%.

About Octapharma

The vision of Octapharma is “Our passion drives us to provide new health solutions advancing human life”. Headquartered in Lachen, Switzerland, Octapharma is one of the largest human protein manufacturers in the world, developing and producing human proteins from human plasma and human cell lines. As a family-owned company, Octapharma believes in investing to make a difference in people’s lives and has been doing so since 1983; because it’s in our blood. Our company values are Ownership, Integrity, Leadership, Sustainability and Entrepreneurship.

In 2017, the Group achieved €1.72 billion in revenue, an operating income of €349 million and invested €287 million to ensure future prosperity. Octapharma employs around 7,700 people worldwide to support the treatment of patients in 113 countries with products across three therapeutic areas:

• Haematology (coagulation disorders)

• Immunotherapy (immune disorders)

• Critical care

Octapharma has seven R&D sites and six state-of-the-art manufacturing facilities in Austria, France, Germany, Mexico and Sweden.

SOURCE: Octapharma

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