NeuroSearch initiates a clinical study with ACR325 for the treatment of dyskinesias (involuntary movements) in Parkinson's disease
08-10-09 kl. 8/10 2009 12:28 | NeuroSearch 3,50 (-0,28%)
Copenhagen, 8 October 2009 - NeuroSearch (NEUR) today announced the initiation
of a clinical Phase Ib study of ACR325, a dopaminergic stabiliser for the
treatment of dyskinesias in Parkinson's disease. Dyskinesias are seriously
disabling involuntary movements that arise following long-term use of L-Dopa,
the standard treatment for advanced-stage Parkinson's disease. NeuroSearch has
received all the necessary approvals to initiate the study and plans to enrol
the first Parkinson patients before the end of October.
The aim of the study is primarily to determine the safety and tolerability of
ACR325 in Parkinson patients and secondly to assess the effects of the compound
on established L-Dopa induced dyskinesias. In the study, patients will be
randomised to receive ascending doses of ACR325 or placebo for three
consecutive seven day periods as an add-on to their usual L-Dopa treatment. At
baseline and at the end of each seven day period, patients will receive a
challenge dose of L-Dopa to momentarily induce dyskinesias, and thereafter
dyskinesias severity and duration are assessed. Safety and tolerability are
assessed throughout the study period. NeuroSearch expects to report data from
the study in 2010.
NeuroSearch has previously evaluated ACR325 in single and multiple clinical
Phase I studies with positive results, showing that ACR325 has a favourable
pharmacokinetic profile after oral administration to healthy volunteers.
Further, the compound proved to be well tolerated at doses exceeding the
predicted therapeutic levels. ACR325 is a dopaminergic stabiliser, exerting
potent effects on brain monoaminergic systems, as manifested, for example, by
increased extracellular levels of dopamine and noradrenaline, in particular in
the frontal cortex. A PET study to investigate the compound's neurochemical
effects in the human brain is ongoing with a view to establish
proof-of-mechanism for the compound in humans.
Flemming Pedersen, CEO of NeuroSearch, commented:
“The findings we have on ACR325 support our belief that this product candidate
holds potential as a new treatment for dyskinesias related to Parkinson's
disease - an area of high unmet medical needs. We see the drug as very
promising, and our decision to advance ACR325 into clinical studies in this
indication is in full accordance with our goal of building a portfolio of
specialist drugs.”
The initiation of Phase Ib studies with ACR325 does not change NeuroSearch's
financial guidance for 2009 of a loss before financials of approximately DKK
350 million.
Flemming Pedersen
CEO
Contact persons:
Flemming Pedersen, CEO, telephone: +45 4460 8214 or +45 2148 0118
Hanne Leth Hillman, Vice President, Director of Investor & Capital Market
Relations, telephone: +45 4017 5103
About dyskinesias in Parkinson's disease
Parkinson's disease is caused by a loss of dopamine-producing nerve cells in
the brain. The cause of the disease is believed to be a combination of genetic
and external factors. The disease is characterised by muscle rigidity and
tremor, and reduced or slow movement. At later stages of the disease, many
patients will also suffer from impairment of learning and memory. It is one of
the most common neurological disorders, and according to Decision Resources
there are 6.5 million patients with Parkinson's disease worldwide. Due to the
rising proportion of elderly people in society, the prevalence is expected to
increase up to four-fold in the next 20 years.
Parkinson's disease cannot be cured, but symptoms can be controlled. The most
important medical treatment is L-Dopa, which is effective in treating the
movement symptoms. However, longtime treatment with L-Dopa leads to the
development of abnormal, involuntary movements, referred to as dyskinesias, in
up to 90% of patients. When severe or painful, dyskinesias limit L-Dopa therapy
resulting in increased rigidity for the patient. Even when mild, it is widely
held that the appearance of dyskinesias foreshadows the development of other,
more disabling motor complications and therefore, may lead the treating
physician to reduce dopaminergic therapy. No effective treatment of L-Dopa
induced dyskinesias is currently available.
About NeuroSearch
NeuroSearch (NEUR) is a Scandinavian biopharmaceutical company listed on NASDAQ
OMX Copenhagen. The core business of the company covers the development of
novel pharmaceutical agents, based on a broad and well-established drug
discovery platform focusing on ion channels and central nervous system (CNS)
disorders. A substantial share of the activities is partner financed through
strategic alliances with Janssen Pharmaceutica, Eli Lilly and Company and
GlaxoSmithKline (GSK), and a license collaboration with Abbott. The drug
pipeline comprises eight clinical (Phase I-III) development programmes:
Huntexil™ (pridopidine) for Huntington's disease (Phase III), tesofensine for
obesity (Phase III ready), ABT-894 for ADHD (Phase II) in partnership with
Abbott, ACR343 for schizophrenia (Phase II ready), ACR325 to treat dyskinesias
in Parkinson's disease (Phase Ib), ABT-560 for the treatment of cognitive
dysfunctions (Phase I) in collaboration with Abbott, NSD-788 for anxiety (Phase
I) and NSD-721 for social anxiety disorder (Phase I) in partnership with GSK.
In addition, NeuroSearch has a broad portfolio of preclinical drug candidates
and holds equity interests in several biotech companies.
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