ABLYNX REPORTS POSITIVE PHASE I DATA FOR ITS ANTI-RANKL NANOBODY
(Thomson Reuters ONE) -
GHENT, Belgium, 20 September 2010 - Ablynx [Euronext Brussels: ABLX] today
announced the first data set from the ongoing Phase I study in 42 healthy
post-menopausal women with ALX-0141, a Nanobody(®) targeting Receptor Activator
of Nuclear Factor kappa B Ligand (RANKL). 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.
The initial safety and PK analyses indicate the following:
* ALX-0141 was well tolerated and no serious adverse events or dose limiting
toxicity occurred;
* No significant difference in the number and severity of adverse events was
reported for subjects receiving ALX-0141 compared with placebo. All
treatment related adverse events were of mild intensity, resolved within the
study period and did not result in withdrawal of a subject from the study.
* After subcutaneous injection, ALX-0141 showed a favourable PK profile,
triggering a prolonged pharmacodynamic (PD) response;
* Serum levels of the lead biomarker, CTX-1, decreased rapidly in all 31
ALX-0141 treated subjects and stayed suppressed (below 70% of the baseline
level) at the 120-day follow-up in 27 subjects (87%) in 5 of the 6 dose
levels.
Due to the unexpectedly long period of suppression of CTX-1 in a large
proportion of the subjects, the follow-up interval of the study has been
prolonged. Results of the final PD, safety and immunogenicity analyses are
anticipated to be published during the first half of 2011.
At present, less than 20% of the subjects have shown normalisation of the lead
biomarker level, indicative of the long-lasting biological activity of ALX-0141.
The study period has therefore been extended to allow for all subjects to be
followed until their biomarker values return to the baseline level.
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(at)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(at)ablynx.com
[HUG#1445220]
complete version of the press release:
http://hugin.info/137912/R/1445220/388636.pdf
This announcement is distributed by Thomson Reuters on behalf of
Thomson Reuters clients. The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and
other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: Ablynx via Thomson Reuters ONE
Unternehmensinformation / Kurzprofil:
Datum: 20.09.2010 - 08:00 Uhr
Sprache: Deutsch
News-ID 42821
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