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)
GHENT, BELGIUM | March 28, 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).
SOURCE: Ablynx
Post Views: 55
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)
GHENT, BELGIUM | March 28, 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).
SOURCE: Ablynx
Post Views: 55
