FDA hits Neumora with clinical hold for schizophrenia drug after preclinical data showed convulsions in rabbits

Neumo­ra Ther­a­peu­tics has hit a road block to be­com­ing a ma­jor neu­ro­science play­er, with the FDA plac­ing a clin­i­cal hold on a Phase 1 study for one of its ear­ly-stage as­sets in schiz­o­phre­nia.

The com­pa­ny said that the tri­al is on hold fol­low­ing “re­cent­ly avail­able” pre­clin­i­cal da­ta for its drug dubbed NM­RA-266 which showed con­vul­sions in rab­bits. Neumo­ra said that 30 pa­tients in the Phase 1 have al­ready tak­en the drug, a mod­u­la­tor of the M4 mus­carinic re­cep­tor, and no con­vul­sions have been re­port­ed.

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