SOURCE: Ablynx

December 14, 2009 12:25 ET

ABLYNX INITIATES PHASE I FOR ALX-0141 (ANTI-RANKL)

GHENT, BELGIUM--(Marketwire - December 14, 2009) - Ablynx [Euronext Brussels: ABLX] announced today that it has initiated a double-blind, randomised, placebo-controlled Phase I study with ALX-0141, a Nanobody® targeting Receptor Activator of Nuclear Factor kappa B Ligand (RANKL), in healthy postmenopausal women.

RANKL is involved in the production of osteoclasts, a type of cell responsible for the destruction of bone (bone resorption). Under normal physiological circumstances there is a delicate balance between bone formation and bone resorption, however, a disturbance in this balance can lead to excessive osteoclast activity and bone loss. An anti-RANKL Nanobody has the potential to inhibit this process and may have therapeutic application in the treatment of degenerative bone diseases, such as post-menopausal osteoporosis (PMO), rheumatoid arthritis and cancer driven bone deterioration.

The Phase I study will investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of a single subcutaneous injection of ALX-0141. In addition, the study will measure important bone biomarkers to provide an early indication of efficacy. Ablynx will recruit up to 42 postmenopausal women, who represent the initial target population for ALX-0141 in PMO.

Dr Edwin Moses, CEO and Chairman at Ablynx, commented: "We are delighted to advance ALX-0141 into the clinic within just 3.5 years of initiating this programme. There are now four Nanobodies in clinical trials including Pfizer's anti-TNF-alpha Nanobody which entered Phase II in September 2009 in patients with rheumatoid arthritis."

About Ablynx [Euronext Brussels: ABLX] - http://www.ablynx.com

Founded in 2001 in Ghent, Belgium, Ablynx is a biopharmaceutical company focused on the discovery and development of Nanobodies, a novel class of therapeutic proteins based on single-domain antibody fragments, for a range of serious and life-threatening human diseases. The Company currently has over 230 employees. Ablynx completed a successful IPO on Euronext Brussels [ABLX] on 7 November 2007.

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Contact Information

  • For more information, please contact:

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    t: +44 (0)20 7866 7857
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    Ablynx:
    Dr Edwin Moses
    Chairman and CEO
    t: +32 (0)9 262 00 07
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    e: Email Contact

    Eva-Lotta Allan
    Chief Business Officer
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    m: +32 (0)475 78 36 21 / +44 (0)7990 570 900
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