ABLYNX
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 II clinical development of ALX-0061 in rheumatoid arthritis and systemic lupus erythematosus.
This Phase II study in SLE is a multi-centre, randomized, double-blind, placebo-controlled, dose-range finding study. It is expected to enrol approximately 300 subjects in the United States, Europe, South America and Asia, who will be randomly assigned to placebo or one of the four different dose groups of ALX-0061. Subjects will be followed for efficacy up to and including week 48 and for safety up to and including week 58.
The study's primary endpoint is the percentage of subjects who achieved a response at week 24 according to the composite BICLA score (BILAG-based Combined Lupus Assessment). This is a broadly accepted, sensitive, clinically meaningful composite measure of SLE disease activity that requires disease improvement across all body systems with moderate or severe baseline activity without concurrent worsening in other body systems or increase in background medication. The secondary endpoints include the composite systemic lupus erythematosus responder index (SRI), the individual components of the composite endpoints, as well the effects of ALX-0061 on health-related quality of life, flare rate and use of corticosteroids. Other planned assessments include the determination of ALX-0061 levels, biomarkers, safety, tolerability and immunogenicity.
"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 2013for the development and commercialisation of ALX-0061.
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.
Ablynxis a biopharmaceutical company engaged in the development of Nanobodies®, proprietary therapeutic proteins based on single-domain antibody fragments, which combine the advantages of conventional antibody drugs with some of the features of small-molecule drugs. Ablynx is dedicated to creating new medicines which will make a real difference to society. Today, the Company has more than
30 proprietary and partnered programmesin development in various therapeutic areas including inflammation, haematology, immuno-oncology, oncology and respiratory disease. The Company has collaborations with multiple pharmaceutical companies including AbbVie, Boehringer Ingelheim, Eddingpharm, Genzyme, Merck & Co., Merck Serono, Novartis and Taisho Pharmaceutical. The Company is headquartered in Ghent, Belgium. More information can be found on www.ablynx.com.
Dr Edwin Moses
CEO
t: +32 (0)9 262 00 07 m: +32 (0)473 39 50 68
e: edwin.moses@ablynx.com
Marieke Vermeersch
Associate Director Investor Relations t: +32 (0)9 262 00 82
m: +32 (0)479 49 06 03
e: marieke.vermeersch@ablynx.com
@AblynxABLX
Sue Charles, Daniel Gooch
London office
t: +44 (0)20 7866 7905
e: ablynx@instinctif.com
Jim Rusagara
Brussels office
t: +32 (0)2 626 9500
e: ablynx@instinctif.com
Certain statements, beliefs and opinions in this press release are forward-looking, which reflect the Company or, as appropriate, the Company directors' current expectations and projections about future events. By their nature, forward-looking statements involve a number of risks, uncertainties and assumptions that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties and assumptions could adversely affect the outcome and financial effects of the plans and events described herein. A multitude of factors including, but not limited to, changes in demand, competition and technology, can cause actual events, performance or results to differ significantly from any anticipated development. Forward looking statements contained in this press release regarding past trends or activities should not be taken as a representation that such trends or activities will continue in the future. As a result, the Company expressly disclaims any obligation or undertaking to release any update or revisions to any forward-looking statements in this press release as a result of any change in expectations or any change in events, conditions, assumptions or circumstances on which these forward-looking statements are based. Neither the Company nor its advisers or representatives nor any of its parent or subsidiary undertakings or any such person's officers or employees guarantees that the assumptions underlying such forward-looking statements are free from errors nor does either accept any responsibility for the future accuracy of the forward-looking statements contained in this press release or the actual occurrence of the forecasted developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release.
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