Pridopidine: Phase II data

The double-blind, U.S. and Canadian Phase II HART trial in 227 patients showed that 45 mg twice-daily Huntexil missed the primary endpoint of significantly improving voluntary motor function as measured by the change from baseline in the mMS subscale of the UHDRS vs. placebo at week 12 (p=0.078). High-dose Huntexil did meet the secondary endpoint of significantly improving the TMS of the UHDRS vs. placebo (p=0.039). There were no significant differences between treatment groups on endpoints for cognition, affective symptoms or generalized function/well-being. NeuroSearch said Huntexil demonstrated a dose-response relationship in which significant improvements from baseline in both mMS and TMS were observed with increasing doses of the compound. Patients received 10, 22.5 or 45 mg twice-daily Huntexil or placebo for 12 weeks. Huntexil was well tolerated. ...