The News

Ablynx initiates Phase I for ALX-0141 (ANTI-RANKL)

14/12/2009

GHENT, Belgium, 14 December 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]
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.
 
 
 
For more information, please contact:
 
College Hill Life Sciences - for International media enquiries:
Sue Charles, Justine Lamond
t:   +44 (0)20 7866 7857
f:   +44 (0)20 7866 7900
e:  ablynx@collegehill.com
 
Ablynx:
Dr Edwin Moses
Chairman and CEO
t:   +32 (0)9 262 00 07
m: +44 (0)7771 954 193 / +32 (0)473 39 50 68
e:  edwin.moses@ablynx.com
 
Eva-Lotta Allan
Chief Business Officer
t:   +32 (0)9 262 00 75
m: +32 (0)475 78 36 21 / +44 (0)7990 570 900
e:  eva-lotta.allan@ablynx.com