Neumora Therapeutics, Inc. announced that the Phase 1 trial of NMRA-266 has been placed on clinical hold by the U.S. Food and Drug Administration (FDA). NMRA-266 is a positive allosteric modulator (PAM) of the M4 muscarinic receptor and is part of the Company?s M4 PAM franchise. The clinical hold determination follows recently available pre-clinical data showing convulsions in rabbits.

Following this action, the Phase 1 single ascending dose /multiple ascending dose study with NMRA-266 has been paused. Approximately 30 participants have been dosed in the Phase 1 study, with no evidence of convulsions observed in any participant. Neumora is working with the FDA to evaluate the potential to resolve the clinical hold.

While these discussions with the Agency are ongoing, the Company?s prior guidance regarding NMRA-266 is no longer applicable. Neumora will provide an update on NMRA-266 when available. Neumora?s M4 franchise includes multiple novel compounds beyond NMRA-266 that each have different properties and chemical composition.

These compounds demonstrated robust activity in preclinical efficacy models, as well as high selectivity for the M4 receptor subtype and the potential for an oral once-daily dosing profile. Neumora is advancing pre-clinical safety and toxicology work with these compounds and expects to submit an IND in 2025.