NeuroSearch Initiates Phase III Programme with ACR16 for the Treatment of Huntington’s Disease

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 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. 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.

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.

For further information please contact:

Flemming Pedersen,

CEO

Tel: +45 44 60 82 14

Email: ns@neurosearch.dk

Or visit: www.neurosearch.com