As corrected, Pridopidine's more particular reason for rejection is also interesting.
The drug was said to be effective against a pre specified subset of 208 individuals who were not taking antidopaminergenic medicines. Their stats on this look reasonably good.
However, the EMA rejected the analytical framework of this subgroup, stating that "the validity and relevance of the results in the subgroup of patients . . . have not been demonstrated." This seems a bit cryptic, but I can think of a couple of possibilities: First, that in the real world virtually everyone is taking dopamine and/or second, Pridopiline worked no better than dopamine, i.e., no better than the current SOC.
By contrast, per clinicaltrials.gov, our Phase 2 PDD trial required participants be on a "stable regime" of a dopamine drug.
Has it been Powerwalker who has been arguing that drug-naive patients seemed to do better in the AD Phase 1 trial under the theory that the other drug competes for space on the Sigma1 receptor? Perhaps that was something that Prilenia thought was happening in the HD space regarding the S1R. In any event, it did not work out for them.
Finally, Pridopiline's commercial name was to have been "Nurzigma," an obvious reference to the Sigma1 receptor MOA.
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