NeuroSearch announces the results of a meta-analysis of data from a clinical Phase II/III programme with Huntexil® for Huntington's disease
30-12-10 kl. 30/12 2010 07:26 | NeuroSearch 3,50 (-0,28%)
Announcement
-- The results of a meta-analysis of pooled datasets from the HART and
MermaiHD studies support the conclusions drawn from each individual trial,
with better precision due to the larger number of observations
-- On the Total Motor Score (TMS), the meta-analysis showed a significant
improvement from treatment with Huntexil®of -2.1 points (p <0.01) at week
12 and of -3.3 points (p <0.001) at week 26
-- On the modified Motor Score (mMS), a -0.6 point (p =0.12) change was seen
at week 12 and a significant improvement of -1.2 points (p <0.01) at week
26
-- NeuroSearch plans to present and discuss the data on Huntexil®with
Regulators during the first half of 2011
Copenhagen, 30 December 2010 - Today, NeuroSearch (NEUR) announced the results
from a meta-analysis performed on 12 and26 week datasets from two clinical
studies with Huntexil®(pridopidine) in the treatment of Huntington's disease: a
26-week Phase III study in 437 patients, the MermaiHD study, and a 12-week
Phase IIb study in 227 patients, the HART study. The meta-analysis used a mixed
effects model for repeated measures.
Huntexil® is a novel drug from a new class of pharmaceutical agents, the
dopidines, which have unique dopaminergic stabilising properties.
On the Total Motor Score (TMS), the meta-analysis showed a significant
improvement compared to placebo from treatment with Huntexil® (45 mg twice
daily) of -2.1 points (95% CI: (-3.6; -0.6), p <0.01) at week 12 (combined
data) and of -3.3 points (95% CI: (-5.3; -1.4), p <0.001) at week 26. TMS is a
standard measure of total motor signs in patients with Huntington's disease. On
the modified Motor Score (mMS), focused on the impairment of voluntary
movements and comprising a subset of items from the TMS, the meta-analysis
showed a placebo-corrected change of -0.6 point (95% CI: (-1.3; 0.15), p =0.12)
at week 12 and a significant improvement of -1.2 points (95% CI: (-2.2;
-0.3), p <0.01) at week 26.
The results of the meta-analysis support the conclusions reported individually
from the MermaiHD and HART studies earlier in 2010, in that treatment with
Huntexil® (45 mg twice daily) has a beneficial effect on patients' motor
symptoms, as measured on the TMS, and a good safety profile. However, neither
study met the predefined significance level for the primary endpoint, mMS.
Chairman of the European Huntington's Disease Network, EHDN, Prof. G.B.
Landwehrmeyer, commented;
“This meta-analysis corroborates prior findings, which taken together indicate
that Huntexil® has the potential to prove to be an important therapeutic
advance in Huntington's disease patients.”
The results of the meta-analysis will be included in the clinical data package
on Huntexil®, which NeuroSearch plans to present to and discuss with Regulatory
Authorities in the US and Europe during the first half of 2011. The outcome of
these discussions will be important in defining the best strategy to obtain
regulatory approval of the drug as a novel treatment for patients with
Huntington's disease.
Patrik Dahlen
CEO
Contact persons:
Patrik Dahlen, CEO, telephone: +45 2629 7296
Hanne Leth Hillman, Vice President, Director of Investor & Capital Market
Relations, telephone: +45 4017 5103
About NeuroSearch
NeuroSearch A/S is a leading CNS focused and European based biopharmaceutical
company listed on NASDAQ OMX Copenhagen A/S (NEUR). The company's core business
is development of novel drugs to treat diseases of the central nervous system
(CNS), and the pipeline comprises eight products in clinical development (Phase
I-III). These include Huntexil® (pridopidine), a unique orphan drug in Phase
III for the treatment of Huntington's disease, and tesofensine ready for Phase
III development as a new type of obesity treatment. NeuroSearch is also
building commercial competences with a view to market Huntexil® through an
in-house sales organisation.
NeuroSearch has a well-established drug discovery platform in the field of ion
channels and monoamine transporters, ensuring the continuous production of
novel pharmaceutical agents. The company has strategic drug discovery and
development alliances with Janssen Pharmaceutica and Eli Lilly as well as a
licence collaboration with Abbott. Further, NeuroSearch has equity interests in
a number of private companies in the Life Science industry.
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