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euroSearch A/S has enrolled and dosed the first patients in a European Phase III study, thereby launching the pivotal clinical programme with ACR16 for the treatment of Huntington’s disease
Ballerup, Denmark | April 25, 2008 | NeuroSearch A/S has enrolled and dosed the first patients in a European Phase III study, thereby launching the pivotal clinical programme with ACR16 for the treatment of Huntington’s disease. The Phase III study is a multi-centre, randomised, double-blind and placebo-controlled study planned to include up to 420 patients suffering from Huntington’s disease. The patients are randomised to receive daily doses of either 45 mg ACR16 (QD), 90 mg ACR16 (BID) or placebo over 26 weeks of treatment. The study is performed at 25-30 centres in eight European countries including Austria, Belgium, France, Germany, Italy, Portugal, Spain and the United Kingdom
The primary endpoint of the Phase III study is to assess the effect of ACR16 on Huntington’s patients’ voluntary motor function, including parkinsonism, gait/balance, hand functionality and bradykinesia measured by the modified Motor Score, mMS, which is a subscale of the Unified Huntington’s Disease Rating Scale (UHDRS). It is well-established among neurologists and in the Huntington’s disease community that the loss of voluntary motor function shows a strong correlation with patients’ functional decline over time. Secondary endpoints in the study include the overall clinical impression of the patients, their cognitive function, neuropsychiatric symptoms such as depression and anxiety as well as assessment of the safety and tolerability of ACR16.
Flemming Pedersen, CEO of NeuroSearch, comments:
“Our ultimate goal in this programme is to be able to offer Huntington’s patients a specific and targeted treatment option which does not exist today. ACR16 has shown promising effects in alleviating some of the most functionally disabling symptoms of the disease, and having dosed the first patients in this comprehensive Phase III programme, we have taken an important step forward in the fulfilment of our goal. We expect that an efficacious treatment for Huntington’s disease is likely to be rapidly adopted by physicians and patients, while also offering significant pharmacoeconomic benefits to societies. The successful preparation and now initiation of this Phase III programme is a major and important achievement for NeuroSearch and we hope in the near future to be able to introduce ACR16 as a novel drug for patients with Huntington’s disease.”
ACR16 belongs to a novel class of active agents called dopaminergic stabilisers, which have the unique ability to either enhance or counteract dopamine dependent functions in the brain, depending on the level of dopaminergic activity. Dopamine is an important neurotransmitter in the brain, and the dopaminergic system plays a central role in the control of motor and mental functions. In preclinical studies dopaminergic stabilisers have demonstrated the ability to stabilise motor, cognitive and psychiatric dysfunction, and they do this without compromising normal brain functions.
Huntington’s disease is a fatal, hereditary neurodegenerative genetic disorder, which leads to damage of the nerve cells in certain areas of the brain including the basal ganglia and cerebral cortex. Patients suffering from Huntington’s disease experience a wide variety of symptoms typically grouped into three categories (the “symptoms triad”): motor, cognitive and psychiatric disorders. Some of the motor symptoms include muscle spasms and rigidity, tics, gait and balance problems as well as chorea and in the later stage of the disease also difficulties in swallowing. The most significant cognitive symptoms are slowed processing of information in the brain, resulting in communicational and planning difficulties, while depression is the most common of the psychiatric symptoms of Huntington’s disease.
The disease occurs at a rate of about one in every 10,000 in most western countries with symptoms onset typically around 35 and 45 years of age. There is currently no cure or effective treatment for Huntington’s disease and the disease progresses without remission over an expected lifespan of 10 to 25 years after symptoms onset. Several medications are prescribed off label, with the sole exception of tetrabenazine, to help control psychiatric and movement problems, but most drugs used have limited effect and are associated with undesirable side effects. Eventually, every person afflicted by Huntington’s disease requires full-time care.
ACR16 was discovered and is developed internally by NeuroSearch, which has the rights to develop and commercialise the compound for the treatment of Huntington’s disease in the European Union, Norway, Switzerland and North America. All other rights to the compound have been outlicensed to Astellas Pharma Inc. ACR16 has been granted orphan drug designation by the EMEA as well as by the FDA.
The initiation of the European Phase III study with ACR16 triggers a payment of SEK 100 million (DKK 80 million/EUR 10.6 million) to the former shareholders of Carlsson Research AB.
NeuroSearch can decide to pay either in cash or by delivery of shares.
NeuroSearch maintains its expectations for 2008 of a loss before financials in the region of DKK 450 million as announced in the 2007 annual report from the beginning of March.
SOURCE: NeuroSearch A/S |
