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news.NeuroSearch has announced that the FDA has approved its investigational new drug application for ACR16, a dopaminergic stabilizer and a novel drug candidate for the treatment of Huntington's disease.
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The investigational new drug (IND) application approval allows NeuroSearch to initiate a planned US study, named Hart, as part of the ongoing clinical program with ACR16. NeuroSearch expects that the Hart study will begin in the second half of 2008.
The Hart study is planned as a randomized, double-blinded and placebo controlled study expected to include 220 patients. In the study, patients will receive daily doses of either 22.5mg (QD), 45mg (QD) or 45mg (BID) ACR16 or placebo to evaluate the efficacy and safety of ACR16 over three months’s treatment.
The primary efficacy endpoint of this study will be the effect of ACR16 on Huntington patients’s voluntary motor function (parkinsonism, gait/balance, hand functionality, bradykinesia) measured by the modified motor score, mMS – a subscale of the unified Huntington’s disease rating scale.
Secondary endpoints include the overall clinical impression of the patients, their cognitive function, neuropsychiatric symptoms such as depression and anxiety. The efficacy endpoints in the Hart study are the same as in the ongoing European MermaiHD study.