Huntexil^® (pridopidine) in Huntington’s disease

Huntexil^® (pridopidine earlier designated ACR16) is the first drug in a new class of therapeutic agents, called dopaminergic stabilisers, and which NeuroSearch is developing for the treatment of Huntington’s disease. NeuroSearch is a Scandinavian biopharmaceutical company specialising in the development of novel drugs for better treatment of central nervous system disorders.
 

Clinical studies with Huntexil^® in Huntington’s disease

The MermaiHD study - Phase III study completed with positive results

On 3 February 2010, NeuroSearch reported positive top-line results from the MermaiHD study, the European Phase III study with Huntexil^® in Huntington's disease, and with the following main conclusions:

•  Huntexil^® significantly improves motor functions in Huntington patients
•  Positive effects observed on both voluntary and involuntary motor symptoms
•  Huntexil^® was very well tolerated with an adverse event profile similar to placebo

The MermaiHD study met the primary endpoint to show an effect on voluntary motor function. In addition, data from the 437 Huntington patients, who participated in the study show that six months' (26 weeks) treatment with Huntexil^® results in significant improvements in a broader range of voluntary and involuntary motor symptoms associated with the disease. The study was conducted in 32 centres across Europe, and showed a very high compliance with 92% of the patients completing the study and 82% in full compliance with the study protocol.

Following the results, NeuroSearch is now initiating interactions with scientific advisors and regulatory agencies (EMEA and FDA) to discuss the MermaiHD study outcome and the plans for submissions for market authorisation for Huntexil^® as a novel treatment for Huntington's disease.

NeuroSearch is also evaluating Huntexil^® in a Phase IIb confirmatory study, the HART study in the USA and Canada, where patient recruitment is still ongoing. Also an open-label treatment extention to the MermaiHD study is still ongoing.

The HART study in North America (the USA and Canada)

The HART study is a randomised, double-blinded, placebo-controlled Phase IIb study, conducted at 28 clinical centres across the USA and Canada to examine the effects of Huntexil^® on the same Huntington’s disease parameters as in the MermaiHD study with a primary focus on motor function. Patients in the HART study are randomly allocated to receive one of three Huntexil^® doses or placebo. The study was initiated with a planned total enrolment of 220 patients with Huntington’s disease and recruitment is still ongoing. Results from the HART study are expected in the second half of 2010.

To enrol in the HART study

If you are interested in participating in the HART study, please contact the US Huntington Study Group on their toll-free number (+1-800-487-7671), or visit their website: www.huntington-study-group.org

Patients, who complete 3-month randomised treatment in the HART study, may be eligible to continued treatment with Huntexil^® upon request from their doctor and subject to FDA (the US Food and Drug Administration and IRB (Institutional Review Board) approval. 

Open-label extention to the MermaiHD study in Europe

The MermaiHD study is followed by an open-label treatment period, which is still ongoing. Patients, who completed the six months' randomised study treatment, have been offered to continue open-label treatment with up to 45 mg Huntexil^® twice daily for six months. Close to 90% of the patients have chosen to continue treatment in the open-label phase, and the last patient is expected to complete the full 12 months treatment period in May 2010. Results from the open-label treatment period are also expected to be available in the second half of 2010.

Please follow this link, if you wish to read more about Huntexil^® (pridopidine). 

 

About Huntexil^® (pridopidine) - a dopaminergic stabiliser

Huntexil^® is the first compund in NeuroSearch's portfolio of dopaminergic stabilisers. Dopaminergic stabilisers have shown a unique ability to help regulate levels of dopamine in the brain – increasing dopamine activity when too low and reducing it when too high. Dopamine is a nerve signal transmitter, playing an essential role in motor control as well as in behaviour and cognition. Huntington’s disease disrupts or disturbs the dopamine activity in different brain regions, leading to the serious motor, cognitive and psychiatric symptoms associated with the disease.

The beneficial effects of Huntexil in Huntington's disease have been demonstrated in a Phase III study, the MermaiHD study. Earlier Huntexil^® has been evaluated also in several smaller studies in Huntington's disease, Parkinson's disease and schizophrenia with very consistent results. In particular, treatment with Huntexil^® has resulted in significant improvements in motor control for patients with Huntington’s disease without beeing associated with worsening of other disease signs and symptoms. In the Phase III study Huntexil^® has also shown to be generally very well tolerated with an adverse event profile similar to placebo.