NeuroSearch files Clinical Trial Application for the initiation of a clinical Phase III programme with ACR16 in Huntington's disease in Europe

Announcement


NeuroSearch files Clinical Trial Application for the initiation of a clinical
Phase III programme with ACR16 in Huntington's disease in Europe 

NeuroSearch has filed a Clinical Trial Application (CTA) in Europe for the
initiation of Phase III clinical studies with the drug candidate ACR16 for the
treatment of Huntington's disease. The European Phase III programme will
involve multiple centres in several countries, including the United Kingdom,
Germany, Austria, France, Belgium, Portugal and Spain. 

The European Phase III programme is planned as a randomised, double-blind,
placebo-controlled study of ACR16 (45 mg or 90 mg daily dosing) for the
symptomatic treatment of Huntington's disease. A total of approximately 420
patients are planned to be enrolled in the study, and dosing will continue for
six months. The selected primary endpoint in the Phase III programme is the
change from baseline in the modified Motor Score (mMS) subscale of the Unified
Huntington's Disease Rating Scale (UHDRS). Secondary objectives are to assess
effects on the patients' overall improvement, behaviour, symptoms of depression
and anxiety, and cognitive functions as well as to assess the safety and
tolerability of ACR16. 

NeuroSearch is also preparing for an Investigational New Drug (IND application
to the FDA for a three months' clinical study in the US. The US and European
studies are planned to provide the basis for international market
authorisations (MA) on ACR16 for the symptomatic treatment of Huntington's
disease. 

Flemming Pedersen, CEO of NeuroSearch, comments:
“The filing of the European Phase III application on ACR16 in Huntington's
disease is a major achievement for our company. We have reached this milestone
timely in accordance with plans, and we are now one important step closer to
having our first product on the market.” 

ACR16 belongs to a novel class of drugs, characterised as dopaminergic
stabilisers, CNS active compounds that can both enhance and counteract
dopaminergic effects in the brain depending on the initial level of
dopaminergic activity. Thus they have the ability to stabilize behavioural and
motor disturbances caused by neurological and psychiatric disorders. They do
this in pathological states without compromising normal thought processes or
motor functions. ACR16 has been successfully investigated in a Phase II
multi-centre, randomised and placebo-controlled trial in patients with
Huntington's disease as well as in three Phase Ib studies within Huntington's
disease, Parkinson's disease and schizophrenia respectively. 

Huntington's disease is a fatal hereditary disease, caused by a faulty gene on
chromosome 4, which leads to damage of the nerve cells in more areas of the
brain. Patients suffering from Huntington's disease experience a wide variety
of symptoms, typically grouped into three categories: motor, cognitive and
psychiatric - often referred to as the “symptoms triad”. The motor symptoms
include chorea, muscle spasms, tics, rigidity and, in the later stage of the
disease, difficulties swallowing. The most significant cognitive symptoms are
slowed processing of information in the brain, resulting in communicational and
planning difficulties, among other symptoms. Depression is the most common of
the psychiatric symptoms of Huntington's disease. Other symptoms include
personality changes, apathy, anxiety, irritability and mania. Huntington's
disease is associated with high unmet medical needs as no effective treatment
exists addressing a range of these symptoms. 



Asger Aamund
Chairman of the Board



Contact persons:

Flemming Pedersen, CEO, phone: +45 4460 8214 or +45 2148 0118

Hanne Leth Hillman, Vice President, Director of Investor Relations & Corporate
Communications, phone: +45 4460 8212 or +45 4017 5103 



NeuroSearch (NEUR) is a Scandinavian biopharmaceutical company listed on the
OMX Nordic Exchange Copenhagen A/S. Our core business covers the development of
novel drugs, based on a broad and well-established drug discovery platform
focusing on ion channels and CNS disorders. A substantial part of the company's
activities are partner financed through a broad alliance with GlaxoSmithKline
(GSK) and collaborations with among others Abbott and Astellas. The drug
pipeline comprises 11 clinical development programmes: ACR16 in Huntington's
disease (Phase III preparation), tesofensine in obesity/type 2 diabetes (Phase
III preparation), NS2359 in depression (Phase II) and ADHD (Phase II) in
partnership with GSK, NS1209 in epilepsy and pain (Phase II), ABT-894 in ADHD
(Phase II) and pain (Phase II) in partnership with Abbott, ACR16 in
schizophrenia (Phase I) in partnership with Astellas, ACR325 in bipolar
disorder (Phase I) and ABT-107 as well as ABT-560 for the treatment of various
CNS diseases - both (Phase I) in collaboration with Abbott. In addition,
NeuroSearch has a broad portfolio of preclinical drug candidates and holds
equity interests in several biotech companies.