NeuroSearch Successfully Completes Phase I with ACR325 And Announces the Decision to Progress Development into Phase II Proof-of-Concept Studies in Parkinson’s disease and Bipolar Disorder
COPENHAGEN, Denmark, June 26, 2008 - NeuroSearch (NEUR.CO)
has completed Phase I evaluation of its drug candidate, ACR325,
with a highly positive outcome. The results of double-blinded,
placebo controlled single and multiple dose studies in healthy
volunteers show that ACR325 has a linear and predictable
pharmacokinetic profile after oral administration. Further, the
compound proved very well tolerated at doses and plasma levels
exceeding by far the predicted therapeutic levels.
Following these positive Phase I results which are fully in line
with promising findings from preclinical studies, NeuroSearch has
initiated preparations to progress ACR325 into Phase II
Proof-of-Concept studies in Parkinson’s disease and Bipolar
Disorder. The first Phase II study will be in Parkinson’s
patients suffering from L-Dopa induced dyskinesias (treatment
related involuntary movements) and is expected to start enrolment
in the second half of 2008. A Phase II study in Bipolar Disorder is
planned to follow.
In preclinical studies, ACR325 has shown efficacy in a range of
models for psychosis and motor disorders, in particular relevant
for the treatment of Bipolar Disorder and motor disturbances
including dyskinesias relating to Parkinson’s disease. Unlike
marketed antipsychotics, ACR325 does not, even at high doses,
suppress locomotor activity, pointing towards good tolerability for
this drug candidate and a potential clinical profile with less or
even no side effects related to movement, motivation and reward.
Further, preclinical results from studies on Parkinson’s
related complications of L-Dopa treatment show that ACR325 has the
ability to prevent the occurrence of motor complications, while
leaving the beneficial treatment effects intact.
Dr. Joseph R. Calabrese*, Bipolar Disorders Research Chair and
Professor of Psychiatry, Co-Director of Bipolar Disorders Research
Center and Director of Mood Disorders Program, University Hospitals
Case Medical Center, Case Western Reserve University, Cleveland,
Ohio commented:
“The novel concept of dopamine stabilisers combined
with the preliminary data on ACR325, provide a convincing rationale
for the development of this compound as a mood stabiliser for use
in the short- and long-term treatment of Bipolar Disorder.
Specifically, the preclinical data suggest that ACR325 may possess
the ability to treat both phases of bipolar disorder at the same
time; the manic phase which is presumed to be a high dopamine
state, as well as the depressed phase, which is believed to be a
low dopamine state. There is tremendous unmet need in the medical
management of bipolar disorder and we are desperately in need of
new treatments.”
* Prof. J.R. Calabrese is member of NeuroSearch’s Scientific
Advisory Board for ACR325
Professor, Dr. Wolfgang Oertel**, Chairman of the Department
of Neurology, Philipps University, Marburg, Germany and a leading
expert in Parkinson’s Disease and other movement disorders,
comments.
“ACR325 is an exciting compound, representing a truly new
approach in the treatment of Parkinson’s patients and
psychosis. L-DOPA is still the mainstay therapy for
Parkinson’s disease, yet leading to dyskinesias and psychotic
events after long-term treatment and as the disease progresses.
ACR325 and dopaminergic stabilizers as a class have the potential
to treat and prevent motor- and psychiatric complications of the
disease and its therapy.”
** Prof. Wolfgang Oertel is member of NeuroSearch’s
Scientific Advisory Board for ACR325.
ACR325 is a dopaminergic stabiliser, belonging to a new class of
compounds with a unique ability to either enhance or inhibit
dopamine controlled functions, depending on the initial level of
dopaminergic activity. Dopamine is a neurotransmitter, playing an
essential role in the control of mental and motor functions. High
levels of brain dopamine lead to psychotic symptoms, while low
levels lead to thought and motor impairment. ACR325 has also
demonstrated an ability to strengthen the glutamatergic and
noradrenalinergic functions, which is an important aspect in novel
treatments for psychosis and motor dysfunctions.
NeuroSearch has all rights to ACR325.
The Phase I results and the decision to progress ACR325 into Phase
II Proof-of-Concept studies do not change NeuroSearch’s
financial expectations for 2008 of an operating loss in the region
of DKK 450 million.
Thomas Hofman-Bang
Chairman of the Board
Contact persons:
Flemming Pedersen, CEO, telephone: +45 4460 8214 or mobile: +45
2148 0118
Hanne Leth Hillman, Vice President, Director of Investor Relations
& Corporate Communications, mobile: +45 4017 5103
