GHENT, Belgium, 28 March 2011 - Ablynx [Euronext Brussels: ABLX] announced today that it had
initiated a double-blind, randomised, placebo-controlled Phase I/II study with ALX-0061, a Nanobody
targeting the interleukin 6 receptor (IL-6R), in patients with rheumatoid arthritis (RA).
IL-6 and its receptor IL-6R are involved in the pathogenesis of various inflammatory and auto-immune
diseases, including RA. ALX-0061 selectively and potently binds to the IL-6R, and has demonstrated a
favourable pharmacodynamic (PD), pharmacokinetic (PK) and safety profile in pre-clinical studies.
ALX-0061 incorporates albumin targeting as a means of half-life extension and this is believed to
improve the delivery of the Nanobody to the inflamed tissue. ALX-0061 may have the potential to
provide a valuable alternative treatment option for patients with RA and other inflammatory diseases.
The Phase I/II study will investigate the safety, PK, PD and efficacy of single and multiple intravenous
administrations of ALX-0061. Ablynx will recruit up to 72 patients with RA in up to ten centres in Europe.
Dr Edwin Moses, CEO and Chairman at Ablynx, commented: “We are delighted to advance ALX-0061
directly into patients with RA, which may lead to a clinical proof-of-concept by 2012. The trial being
initiated today brings the total number of Nanobodies in clinical trials to six.”
About ALX-0061 (IL-6R)
ALX-0061 is a Nanobody binding to the interleukin-6 receptor (IL-6R). It has the potential to differentiate
through its high potency, high stability and low molecule weight of only 26kD which should translate
into superior tissue penetration, attractive PK/PD and superior safety and efficacy profile compared with
a benchmark monoclonal antibody. The Nanobody is half-life extended with a Nanobody targeting
albumin, which is believed to improve the delivery of the Nanobody to the inflamed tissue. An IMPD was
filed with ALX-0061 in December 2010.
The involvement of the IL-6 pathway in a variety of diseases indicates that multiple indications can be
pursued with large market potential including rheumatoid arthritis (RA), Crohn’s disease, Castleman’s
disease, multiple myeloma and systemic lupus erythematosus (SLE). Although there are biologics on
the market for treatment of RA, there is a clear unmet medical need for novel RA treatments as many
patients are not sufficiently helped with the current disease-modifying therapies such as TNF-a
therapies and methotrexate. |
