Been busy with other stuff, so posting this rather late, but it looked interesting:
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. This extension will not interfere with the anticipated start of the Phase II clinical
study in the second half of 2011.
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 pharmacological profile and we are
assessing the importance of these results for the future development of the drug. We expect to
have the final Phase I data during the first half of 2011 and then plan to initiate a Phase II study in
patients with bone metastases during the second half of 2011.” |
