GHENT, Belgium, June 10, 2014 (GLOBE NEWSWIRE) -- Ablynx [Euronext Brussels: ABLX] today announced that it will present additional positive data on its anti-IL-6R Nanobody®, ALX-0061, at the Annual European Congress of Rheumatology (EULAR), which is taking place from 11 to 14 June in Paris, France.
The poster presentation will include results from a post-hoc analysis of data collected in a24-week combined Phase I/II study in patients with moderately-to-severely active rheumatoid arthritis (RA) on a stable background of methotrexate. These data show that, in patients with established RA, intravenously administered ALX-0061 induces and maintains remission as assessed by both DAS28 criteria and the more stringent Boolean remission definition. Control of disease activity with ALX-0061 results in regaining normal physical function, supporting treat-to-target management of RA as reflected in the EULAR recommendations.
The abstract "Impact of Clinical Remission on Physical Function in Patients with Rheumatoid Arthritis Treated with ALX-0061: Post-hoc Analysis of Phase I/II Data" is available on the EULAR website at http://www.eular.org (Abstract No. FRI0329; Poster Presentation on Friday, 13 June) and shortly after the presentation, the poster will be available on Ablynx's corporate website (via this link).
ALX-0061 targets the interleukin-6 pathway via its IL-6 receptor (IL-6R), which plays a key role in the inflammation process in RA. ALX-0061 has been designed to become a best-in-class therapeutic. Its small size (26kD) may potentially allow ALX-0061 to penetrate more effectively into tissues. The potent, monovalent interaction of the molecule with its target reduces the possibility of off-target effects. Its binding to human serum albumin prolongs the in vivo half-life of the product and can lead to improved trafficking to areas of inflammation. The Nanobody has a very strong affinity for soluble IL-6R which should ensure fast target engagement and could result in a fast onset of effect.
In September 2013, Ablynx and AbbVie entered into a global license agreement, worth up to US$840 million plus double-digit royalties, to develop and commercialise ALX-0061. As part of the agreement, Ablynx is responsible for Phase I and Phase II clinical development of subcutaneous (sc) ALX-0061 in RA and systemic lupus erythematosus (SLE).
Ablynx has recently initiated a Phase I bioavailability study with the sc formulation of ALX-0061. Results of the study are anticipated by the end of 2014, with the goal to start Phase II clinical development of ALX-0061 sc in both RA and SLE patients in 2015. Upon the achievement of pre-defined Phase II success criteria, AbbVie will exercise its right to in-license ALX-0061 and be responsible for subsequent Phase III clinical development and commercialisation.
About RA and SLE
RA is characterized by chronic and progressive joint inflammation that typically results in permanent, debilitating tissue damage, which is further compounded by joint deformation. The condition is associated with lower quality of life, premature death, disability, and unemployment. It is estimated that up to 1 percent of the adult population worldwide suffer from RA.
SLE is a complex, multi-organ, autoimmune disorder characterised by the production of pathogenic autoantibodies and tissue deposition of immune complexes, which result in widespread tissue damage. Although the aetiology of SLE is not fully understood, multiple genetic, environmental, and hormonal factors have been implicated in its development. The disease displays a broad variety of symptoms and highly variable clinical features, including systemic, cutaneous, renal, musculoskeletal and haematological manifestations. Approximately 5 million people worldwide suffer from a form of lupus and 90 percent of people diagnosed are women.
The European League Against Rheumatism (EULAR) is the organisation which represents the patient, health professional and scientific societies of rheumatology of all the European nations. EULAR defines rheumatology as including rheumatic diseases of the connective tissue, locomotor and musculoskeletal systems.
The aims of EULAR are to reduce the burden of rheumatic diseases on the individual and society and to improve the treatment, prevention and rehabilitation of musculoskeletal diseases. To this end, EULAR fosters excellence in education and research in the field of rheumatology. It promotes the translation of research advances into daily care and fights for the recognition of the needs of people with rheumatic diseases. At the European political level, EULAR is representing the interests of the entire rheumatic disease community and is the natural partner of European policy makers when policies and regulatory frameworks are developed.
For more information on EULAR and its recommendations, please visit http://www.eular.org/index.cfm?framePage=/recommendations_home.cfm
Ablynx is a biopharmaceutical company engaged in the discovery and development of Nanobodies®, a novel class of therapeutic proteins based on single-domain antibody fragments, for a range of serious human diseases, including inflammation, haematology, oncology and pulmonary disease. Today, the Company has more than 30 programmes in the pipeline and seven Nanobodies in clinical development. Ablynx has on-going research collaborations and significant partnerships with major pharmaceutical companies including AbbVie, Boehringer Ingelheim, Merck & Co, Merck Serono and Novartis. The Company is headquartered in Ghent, Belgium. More information can be found on www.ablynx.com.
For more information, please contact
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pdf format of the press release http://hugin.info/137912/R/1791557/616317.pdf