GHENT, Belgium, Nov. 14, 2014 (GLOBE NEWSWIRE) -- Ablynx [Euronext Brussels: ABLX] today announced that it will present two posters on its novel anti-IL-6R Nanobody®, ALX-0061, at the 2014 American College of Rheumatology (ACR/ARHP) Annual Meeting, which is taking place from 14 to 19 November 2014 in Boston, MA, USA.
The first poster presentation will include results from a post-hoc analysis of data collected in a 24-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. These results suggest that ALX-0061 has the potential for disease modifying activity which supports treat-to-target management of RA.
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 ACR website at http://www.acrannualmeeting.org/ (Abstract No. 1479; Poster Presentation #1454 on Monday 17 November 2014) and shortly after the presentation, the poster will be available on Ablynx's corporate website (via this link).
The second poster presentation will include data from in vitro experiments that assessed the biological activity and affinity of ALX-0061 for both the soluble and membrane-bound IL-6-receptor as compared to tocilizumab (Actemra®). The in vitro results support the preferential inhibition of soluble IL-6R trans-signalling by ALX-0061, which may result in a more favourable benefit-risk profile compared to tocilizumab.
The abstract "ALX-0061, an anti-IL-6R Nanobody for use in rheumatoid arthritis, demonstrates a different in vitro profile as compared to tocilizumab" is available on the ACR website at http://www.acrannualmeeting.org/ (Abstract No. 1498; Poster Presentation #1473 on Monday 17 November 2014) 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 have the potential 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). Positive Phase I results in healthy volunteers, demonstrating a high bioavailability and a benign safety profile, were reported in October. RA and SLE phase II studies are scheduled to start 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 characterised by chronic and progressive joint inflammation that typically results in permanent, debilitating tissue and bone damage subsequently leading to joint deformities when left untreated. 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.
Ablynx is 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 programmes in development in therapeutic areas including inflammation, haematology, oncology and respiratory disease. The Company has collaborations and significant partnerships with 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
Dr Edwin Moses
t: +32 (0)9 262 00 07
m: +44 (0)7771 954 193 /
+32 (0)473 39 50 68
Associate Director Investor Relations
t: +32 (0)9 262 00 82
m: +32 (0)479 49 06 03
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Ablynx media relations Consilium Strategic Communications:
Mary-Jane Elliott, Amber Bielecka, Lindsey Neville
t: +44 203 709 5700
pdf format of the press release http://hugin.info/137912/R/1871230/658296.pdf