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Ablynx provides update on its ongoing Phase I study for ALX-0141


GHENT, Belgium, 9 January 2011 - Ablynx [Euronext Brussels: ABLX] announces an update on its ongoing Phase I study in 42 healthy post-menopausal women treated with ALX-0141, a Nanobody® targeting Receptor Activator of Nuclear Factor kappa B Ligand (RANKL).

In September 2010, at 120 days follow-up, positive safety data were reported, as well as data on the pharmacokinetics (PK) of ALX-0141. The double-blind, placebo-controlled Phase I study was designed to assess safety, tolerability and PK of a subcutaneous injection of ALX-0141. In addition, serum levels of certain bone biomarkers were measured, to provide an early indication of efficacy. ALX-0141 was administered in 6 dose levels as a single subcutaneous injection ranging from 0.003 mg/kg to 1 mg/kg.

At the 9 month follow-up time point, statistically significant suppression of the bone biomarker CTX-1 was noted. Following a single dose of 1mg/kg, 4 out of 6 subjects (67%), in this highest dose group, showed statistically significant suppression of CTX-1 at 9 months and will be followed-up until their biomarker normalizes. As a comparison, published Phase I data for denosumab (a monoclonal antibody also targeting RANKL and developed by Amgen which some analysts predict will reach peak sales of $3 billion) also showed statistically significant suppression of another bone biomarker, serum NTX-1, for 9 months at the highest dose level of 3mg/kg.

Dr Edwin Moses, CEO and Chairman at Ablynx, commented: “The prolongation of biomarker suppression beyond the expected endpoint confirms the high biological activity of ALX-0141. We are delighted with the positive safety data and the drug’s PK/PD profile and we are assessing the importance of these results for the future development of the drug. We expect to have the final biomarker data available by the second quarter of 2011.”

About ALX-0141 and Receptor Activator of Nuclear Factor kappa B Ligand (RANKL)
Through its binding and activation of the RANK receptor, RANKL plays a critical role in the maturation, survival and activation of a type of cell responsible for the destruction of bone (osteoclasts). 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. Increased bone resorption and/or decreased bone formation are often hallmark symptoms of osteoporosis, cancer-induced bone loss or rheumatoid arthritis (RA) related bone erosion. ALX-0141 has the potential to inhibit this process and may have therapeutic application in the treatment of degenerative bone diseases, such as post-menopausal osteoporosis, rheumatoid arthritis and cancer driven bone deterioration.

ALX-0141 is a sequence optimised Nanobody that targets the RANKL. RANKL, via interaction with its cognate receptor RANK, is the central regulator of bone resorption and it activates cells involved in bone resorption. Overproduction of RANKL is implicated in a variety of degenerative bone diseases, such as osteoporosis, RA and bone metastases. ALX-0141 is currently in Phase I clinical development. ALX-0141 has potential to be developed in a range of indications including the treatment of osteoporosis, bone metastases in cancer and bone erosion associated with RA.

ALX-0141, like denosumab (Prolia®/Xgeva®), has a novel mechanism of action that differentiates it from other anti-resorptive agents as it intervenes in bone erosion at the level of osteoclast differentiation, activation, and survival. ALX-0141 inhibits bone resorption by targeting and binding to RANKL and thereby preventing RANKL from binding to receptors on the surface of osteoclasts.

About Ablynx
Ablynx (Euronext: ABLX) is a biopharmaceutical company engaged in 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, including inflammation, thrombosis, oncology and Alzheimer’s disease. Today, the Company has over 25 projects in the pipeline and there are five Nanobodies in clinical development. Ablynx has ongoing research collaborations and significant partnerships with major pharmaceutical companies, including Boehringer Ingelheim, Merck Serono, Novartis and Pfizer. The Company is headquartered in Ghent, Belgium and currently employs over 250 people. More information can be found on www.ablynx.com.


For more information, please contact 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
Marieke Vermeersch
Investor Relations Manager
t: +32 (0)9 262 00 82
m: +32 (0)479 49 06 03
e: marieke.vermeersch@ablynx.com


Certain statements, beliefs and opinions in this press release are forward-looking, which reflect the Company’s or, as appropriate, the Company’s directors’ current expectations and projections about future events. By their nature, forward-looking statements involve a number of risks, uncertainties and assumptions that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties and assumptions could adversely affect the outcome and financial effects of the plans and events described herein. A multitude of factors including, but not limited to, changes in demand, competition and technology, can cause actual events, performance or results to differ significantly from any anticipated development. Forward looking statements contained in this press release regarding past trends or activities should not be taken as a representation that such trends or activities will continue in the future. As a result, the Company expressly disclaims any obligation or undertaking to release any update or revisions to any forward-looking statements in this press release as a result of any change in expectations or any change in events, conditions, assumptions or circumstances on which these forward-looking statements are based. Neither the Company nor its advisers or representatives nor any of its or their parent or subsidiary undertakings or any such person’s officers or employees guarantees that the assumptions underlying such forward-looking statements are free from errors nor does either accept any responsibility for the future accuracy of the forward-looking statements contained in this press release or the actual occurrence of the forecasted developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release.


Publisher Contact Information:

Ablynx
+32 9 262 00 00
ciska.vansteenkiste@ablynx.com

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