GHENT, BELGIUM--(Marketwire - January 09, 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.”
Complete version of the press release: http://hugin.info/137912/R/1478138/414028.pdf
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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: Email Contact
Marieke Vermeersch
Investor Relations Manager
t: +32 (0)9 262 00 82
m: +32 (0)479 49 06 03
e: Email Contact
