Danish biopharmaceutical company NeuroSearch has announced positive top line results from a phase III study of Huntexil (pridopidine), a candidate drug for the treatment of Huntington's disease, reports financial daily newspaper Børsen. The company's share price rocketed 78% on the news.
The six-month study showed a significant improvement in the motor function of Huntington's disease patients, and positive effects on both voluntary and involuntary motor symptoms. Huntexil was also very well tolerated with a safety profile similar to placebo. 90% of the patients enrolled in the study have chosen to continue treatment in an open-label phase for a further six months.
NeuroSearch is now taking up dialogue with scientific advisors and regulatory agencies (EMEA and FDA) to discuss the outcome of the study and plans for submissions for market authorisation for Huntexil as a novel treatment for Huntington's disease.
Huntexil is also being evaluated in a placebo-controlled study in the US and Canada involving around 220 patients with Huntington's disease. Patient recruitment is still ongoing, and study results are expected in H2 2010.
Huntexil is one of a novel class of drugs called dopaminergic stabilisers, which can stabilize behavioural and motor disturbances caused by neurological and psychiatric disorders, without compromising normal thought processes or motor functions.
Huntington’s disease is a rare, inherited neurological disorder first described by the New York physician George Huntington in 1872. It is caused by a faulty gene which leads to progressive degeneration of nerve cells in the brain, resulting in a wide and distressing range of symptoms. The prevalence of Huntington’s disease is 5 to 8 per 100,000, varying geographically.
Headquartered in the Copenhagen suburb of Ballerup, NeuroSearch develops 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 strategic alliances with GlaxoSmithkline (GSK), Janssen Pharmaceutica and Eli Lilly & Co. NeuroSearch is listed on the Nasdaq OMX Nordic Exchange.