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 (= ITT population) showed that six months' (26 weeks) treatment with Huntexil results in 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 per cent of the patients completing the study and 82 per cent in full compliance with the study.
Treatment with Huntexil 45mg BID (twice daily) demonstrated statistically and clinically improvements compared to placebo in the ITT population on the following measures of motor symptoms in Huntington's disease. Treatment with Huntexil 45mg QD (once daily) showed some improvements on these motor function domains, however did not reach statistical significance.
The improvements in motor function observed with Huntexil 45mg twice daily in the MermaiHD study appear very robust, as they remain consistent across assessments and analyses. They showed increasing separation from placebo over time and are consistent across the two pre-stratified study groups of patients on use/non-use of antipsychotic medication (approximately 40 per cent of patients were on antipsychotics).
The importance of studying both patient groups has been emphasized by experts and regulators to demonstrate that Huntexil improves the symptoms of Huntington's disease per se, and that it is also safe in patients treated with antipsychotics. The use of antipsychotics showed no influence on the positive treatment effects of Huntexil.
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.
Flemming Pedersen, CEO of NeuroSearch, said: "The Phase III results from the MermaiHD study are very encouraging,demonstrating that Huntexil can provide significant benefits to huntington patients on symptoms not reached by any current treatment, and this without any 'trade-offs' in terms of safety or worsening of any other disease symptoms. We remain determined to bring Huntexil forward as a new medication to patients with Huntington's disease and we will work closely with physicians and regulatory authorities to make this happen as soon as possible."