ACR16 closer to Phase III clinical trials

Neurosearch applied for permission to start Phase III clinical trials of ACR16, a dopamine stabilizer, in Europe and the U.S.
ACR16 is a dopamine stabilizer which improved movement and cognition in a small Phase II clinical trial. (See HDL: Swedish Company Announces Results of Phase II study of Dopamine Stabilizing Compound.) Neurosearch has applied to start Phase III clinical trials in both Europe and the United States. ACR16 was given fast track status by the FDA in 2006.

The drug will be tested as a symptomatic treatment although it may be an actual treatment for the disease itself. This way, if the drug is effective for symptoms, it could be available to patients much quicker.

Marsha L. Miller, Ph.D.
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.

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