GHENT, BELGIUM--(Marketwire - November 09, 2012) - Ablynx (EURONEXT BRUSSELS: ABLX) today announced that it will present data from two Nanobody®-based products in rheumatoid arthritis (RA) at the annual meeting of the American College of Rheumatology (ACR) from 10-14 November in Washington D.C., USA. The poster presentations will be based on the outcome of pre-clinical and clinical studies that have previously been disclosed.
Ablynx will have three poster sessions including two posters on its novel IL-6R Nanobody, ALX-0061, and one poster on its novel anti-TNFa Nanobody, ozoralizumab (ATN-103).
ALX-0061 is a bi-specific IL-6R targeting Nanobody with monovalent binding to IL-6R and human serum albumin. Translational modelling studies resulted in a novel first-in-human design that combined a single-ascending dose, a multiple ascending dose and clinical POC using pharmacokinetics, biomarker and early clinical read outs as decision tools. Earlier reported results from the 12 week interim analysis of the Phase I/II study demonstrate that ALX-0061 has the potential to become a best-in-class IL-6R inhibitor in RA with a strong efficacy profile based on a 80% ACR20 response, a 60% DAS28-CRP remission rate, and a fast onset of DAS28-CRP remission; and an excellent safety profile with no serious infections, no decrease in neutrophils, no clinically significant increases in liver enzymes and no increases in lipid levels (cholesterol and LDL) being observed.
Ozoralizumab, ATN-103, a novel TNFa inhibitor, is a trivalent, bi-specific Nanobody that potently neutralises TNF and binds to human serum albumin to increase its in vivo half-life. The results from the Phase II open-label extension study demonstrated that ozoralizumab enables highly effective and well-tolerated individualised treatment. The specific molecular features of Nanobodies, including their small size, low immunogenic potential and manufacturability, contributed to the desired outcome, with the majority of patients showing marked improvement in their disease activity. Moreover, the once-induced remission could be maintained at doses less than 80mg monthly. This treatment approach could be beneficial to patients and minimise treatment costs.
Details on the poster sessions
Abstract/poster #336: Pre-clinical development of ALX-0061, an anti-IL-6R Nanobody for therapeutic use in rheumatoid arthritis with a high in vitro affinity and potency and a competitive in vivo pharmacological profile - 11 November
Abstract/poster #1307: Anti-IL-6 receptor Nanobody (ALX-0061) seamless "first-in-human" Phase I/II POC study in patients with active RA on stable MTX treatment- 12 November
Abstract/poster #1311: A novel individualised treatment approach in open-label extension study of ozoralizumab (ATN-103) in subjects with rheumatoid arthritis on a background of methotrexate - 12 November
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 approximately 25 programmes in the pipeline and seven Nanobodies at clinical development stage. Ablynx has ongoing research collaborations and significant partnerships with major pharmaceutical companies including Boehringer Ingelheim, Merck KGaA, Novartis and Merck & Co. The Company is headquartered in Ghent, Belgium. More information can be found on www.ablynx.com.
press release in pdf: http://hugin.info/137912/R/1656461/535559.pdf