Ablynx initiates Phase I/II trial for ALX-0061 (Anti-IL-6R) in patients with rheumatoid arthritis

30-Mar-2011 - Belgium

Ablynx  announced 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.

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