Drug Development

Pridopidine is still a mess in latest Huntington’s study, but Teva maps PhIII

Six years ago a Danish company called NeuroSearch enjoyed a few days in the sun when it said its experimental drug for Huntington’s diease, Huntexil (pridopidine), had scored positive data for improving motor functions in patients in a Phase III study. But a few weeks later the company was battered by a reassessment of the data, which concluded that the drug had failed.

Karl Kieburtz, University of Rochester

Karl Kieburtz, University of Rochester

NeuroSearch never recovered from that setback. But Teva in-licensed the drug. And this week it unveiled new Phase II data on Huntexil, which continues to perform unevenly in clinical studies.

Once again the drug failed to improve motor functions in patients. But Teva says it got encouraging data in a subpopulation of early stage patients, recording an improvement in Total Motor Score and dystonia observed at 26 and 52 weeks at specific doses.

Now Teva says it’s ready to go back into Phase III, this time armed with some additional insights on the drug’s mechanism of action.

Teva’s investigators say they discovered that the drug is a Sigma 1 Receptor (S1R) treatment, putting it into a more widely known pipeline that has been studied closely for neurodegenerative conditions. And that new knowledge prompted the company to change the study from a 26-week trial, where the drug flopped, to 52 weeks.

Karl Kieburtz, director of the Clinical & Translational Science Institute at the University of Rochester Medical Center, had this to say:

“These study results are very important for the HD community and for the continued development of pridopidine. Firstly, pridopidine’s safety profile has been confirmed and extended. Secondly, we now have a clearer idea of the dosages to study in Phase 3. Lastly, we have some of the most encouraging evidence to date about an intervention which may slow the inexorable functional decline of HD.”

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