ABLYNX INITIATES PHASE II SLE STUDY WITH ITS ANTI-IL-6R NANOBODY, PARTNERED WITH ABBVIE - Seite 2

Dr Edwin Moses, CEO of Ablynx, commented:
"Ablynx and our partner AbbVie are committed to making ALX-0061 available for patients suffering from debilitating inflammatory diseases including rheumatoid arthritis and systemic lupus erythematosus. The efficacy and safety of this novel anti-IL-6R Nanobody is currently being evaluated in multiple Phase II studies with results from the RA studies anticipated in the second half of 2016 and SLE in 2018. If the results meet the pre-defined success criteria, AbbVie will exercise its right to in-license ALX-0061 and be responsible for subsequent development and commercialisation."

About ALX-0061
ALX-0061 targets the interleukin 6 pathway via its IL-6 receptor (IL-6R) and is being developed for the treatment of RA and SLE. IL-6 is a pro-inflammatory cytokine that plays a role in T-cell activation, production of acute phase proteins in response to inflammation, induction of immunoglobulin production, and stimulation of osteoclast differentiation and activation. ALX-0061 (26kD) has a very strong affinity for the soluble IL-6R and contains an anti-IL-6R Nanobody linked to an anti-human serum albumin (HSA) Nanobody, thereby increasing the in vivo serum half-life. Phase I/II proof-of-concept results with ALX-0061 were published in February 2013, followed by the signing of a global exclusive licensing deal with AbbVie in September 2013 for the development and commercialisation of ALX-0061.

About SLE and 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.

RA is characterised 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.